SECRETARY OF LABOR,
EMERY CHEMICALS, DIVISION OF NATIONAL
DISTILLERS AND CHEMICAL CORPORATION,
LOCAL UNION 14340, UNITED STEELWORKERS
OSHRC Docket No. 86-0457
The Parties' stipulation and settlement agreement is
approved. This order is issued pursuant to a delegation of authority to the
Executive Secretary. 41 Fed. Reg. 37173 (1976), amended at 44 Fed. Reg. 7255 (1979).
FOR THE COMMISSION
Ray H. Darling, Jr.
Dated: November 18, 1987
SECRETARY OF LABOR,
EMERY CHEMICALS, DIVISION OF
NATIONAL DISTILLERS AND
LOCAL UNION 14340, UNITED STEEL
WORKERS OF AMERICA,
OSHRC Docket No. 86-0457
APPEARANCES: Bruce C. Heslop, Esquire, Office of the Solicitor, U.S. Department of Labor, Cleveland, Ohio, on behalf of complainant.
Robert E. Denham, Esquire, National Distillers and
Chemical Corporation, Cincinnati, Ohio, on behalf of
Mr. Richard Smith, Chairman, Safety Committee, Local
14340, United Steelworkers of America, on behalf of
authorized employee representative.
DECISION AND ORDER
SPARKS, Judge: Respondent, Emery Chemicals, Division of National Distillers and Chemical Corporation ("Emery") owns and operates a workplace at 4900 Este Avenue, Cincinnati, Ohio, for the manufacture of specialty chemicals (Tr. 24). Uses of the respondent's products include synthetic lubricants, cosmetics and toiletries, paints, detergents, rubber goods, plastics, adhesives and textile chemicals.
On December 2, 1985, representatives of the Secretary conducted a Special Emphasis Program inspection of Emery's Plant (Tr. 19) designed to determine Emery's compliance with those elements of OSHA's Hazard Communication Standard, 29 C.F.R. § 1910.1200 et seq. ("the Standard") which became effective on November 25, 1985 (Tr. 19, 20). During the course of the December 2, 1985, inspection, five Material Safety Data Sheets ("MSDS's") and five labels were provided to OSHA's compliance safety and health officer (Tr. 21). On March 4, 1986, a closing conference was held at Emery's Plant. Thereafter, a four-item citation for other than serious violations was issued by OSHA on March 7, 1986, alleging various deficiencies in Emery's labels and MSDS's. No penalty was proposed. The Company's notice of contest was filed on April 3, 1986. Party status was accorded Local 14340 of the United Steelworkers of America, AFL-CIO, by order of the Review Commission dated May 19, 1986.
The citation in this proceeding involves two principal issues. The first is addressed by item one which alleges violations relating to the labels used by Emery on containers of five Emery products. The Secretary contends that these labels are deficient in that they failed to contain "appropriate hazard warnings" as mandated by 29 C.F.R. § 1910.1200(f)(1)(ii). The second main issue--addressed by items two through four--involves the MSDS for one Emery product, Emerox 1110 Azelaic Acid. The Secretary alleges that this MSDS did not properly list the chemical ingredients (item two) and physical and chemical characteristics (item three) of Azelaic Acid, and that emergency and first aid procedures for this substance were inadequate (item four).
Pursuant to a stipulation by the parties at the hearing, it is found that the substances referred to in the citation, specifically Emerox 1110, Emery 658, Emersol 6357, Emery 1202 and Emery 878 are produced by respondent for shipment out of the plant to manufacturing sector customers (Tr. 6).
At the hearing, the Secretary moved to amend item four of the citation to substitute the term "inhalation" for "ingestion"[[1/]] (Tr. 6). Respondent vigorously opposed the amendment at the hearing and moved for reconsideration of the ruling granting the motion. The motion to amend was granted, and respondent afforded an opportunity to overcome any alleged prejudice although none was shown. Respondent did not avail itself of the opportunity to offer further evidence but has renewed its opposition to the amendment. After reconsideration, it is held that the amendment was proper under the circumstances and the ruling is affirmed.
The OSHA "hazard communication standard," 29 C.F.R. § 1910.1200, provides that by November 25, 1985, chemical manufacturers and importers shall label containers of hazardous chemicals leaving their workplaces and provide material safety data sheets with initial shipments.[[2/]] See § 1910.1200(j)(1). The purpose of the standard, as set forth in 1910.1200(a)(1), is:
[T]o ensure that the hazards of all chemicals produced or imported by chemical manufacturers or importers are evaluated, and that information concerning their hazards is transmitted to affected employers and employees within the manufacturing sector. This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training.
The standard is unique in its requirement for
"downstream" disclosure of information regarding hazardous chemicals from
chemical manufacturers and importers to employer-purchasers of such products. See
§ 1910.1200(b)(1). The full and accurate downstream flow of information regarding
hazardous chemicals is essential to complete implementation of the standard's requirements
by manufacturing sector employers who purchase such products. See generally
§ 1910.1200(d)(1), § 1910.1200(e) and § 1910.1200(h). To initiate this downstream
flow of information, the standard requires chemical manufacturers, such as respondent, to
evaluate chemical substances produced in their workplace to determine if they are
hazardous, see § 1910.1200(b)(1) and (d), to ensure that each container of
hazardous chemicals leaving its workplace is appropriately labeled, tagged or marked, see
§ 1910.1200(f), and to develop a material safety data sheet for each hazardous chemical
they produce, see § 1910.1200(g).
Item one of the citation alleged that the labels used on five of respondent's products[[3/]] failed to comply with § 1910.1200(f)(1)[[4/]], in that they were not labeled, tagged or marked with "appropriate hazard warnings." More specifically, the Secretary contends that the labels on the products were deficient in that they failed to warn of the hazard to target organs.
A threshold question is whether the materials listed in item one were hazardous chemicals which were subject to the HCS. The term "hazardous chemical" is defined in § 1910.1200(c) as ". . . any chemical which is a physical hazard or a health hazard." The Secretary does not contend the chemicals are physical hazards so we are concerned only with whether either is a "health hazard."[[5/]] Neither are any of the chemicals specifically named on any of the lists of chemicals subject to the HCS.
Appendices A and B, which are incorporated in the
definition, "provide[s] further definition and explanations of the scope of health
hazards covered by this section . . . and describe the criteria to be used to determine
whether or not a chemical is to be considered hazardous for purposes of this
standard." The standard is performance oriented and requires the employer to
evaluate the scientific data available and make a determination as to the information
required on the MSDS and labels. The standard does not require that an employer
perform any testing but does envision a search of scientific literature to determine the
reported results of studies "which are designed and conducted according to
established scientific principles, and which report statistically significant conclusions
regarding the health effects of a chemical" (Appendix B, para. 4).
The Secretary relied upon data shown on the MSDS and determined that four of the five products at issue, Emery 658, Emerson 6357, Emery 1202 and Emery 878, contained ingredients comprising more than one percent of the product which presented a "corrosive" hazard (Exs. 2A, 2B, 2C, 2D; Tr. 37-38). Respondent does not seriously contest the determination that the four named products are properly classed as hazardous chemicals (Tr. 153) but does vigorously oppose the finding that the fifth product, Emerox 1110, is a hazardous chemical. Complainant contends that Emerox 1110, which contains 80 percent azelaic acid and more than one percent of adipic acid, presents an "irritant" hazard (Ex. C-6). In support of that contention, the Secretary notes that a revised MSDS for Emerox 1110 was filed shortly after the inspection which lists the two ingredients as "irritants"[[6/]] (Ex. C-6. section II). There is some confusion in the record, because the product is known by both Emerox 1110 and its principal chemical, azelaic acid. On the revised MSDS, the product is identified as Emerox 1110 Azelaic Acid (Ex. C-6).
The record as a whole does not support the conclusion that azelaic acid is an irritant. Patty's Industrial Hygiene and Toxicology, which is listed in Appendix C to § 1910.1200 as an "Information Source," states the acute effects of azelaic acid as follows (Ex. C-5 p. 4949):
Azelaic acid appears to have low acute toxicity. In the rabbit 500 mg azelaic acid produced only a mild skin irritation in 24 hrs. and 3 mg was only a mild eye irritant (123).
Respondent's expert toxicologist, Dr. Marian Vinegar,
examined the basic data of the studies reported by Patty's and determined that the
findings of the studies would require that azelaic acid be classed as a non-irritant
pursuant to the definition in Appendix A, Section 4, of the HSC [[7/]] (Tr. 133-134, 144).
A study conducted under contract with the Air Force to determine the toxicity of a
number of materials, including azelaic acid, found that there was "no
irritation" caused by azelaic acid (Ex. R-3; Tr. 135-140). Emery also commissioned a
test of the toxicity of Emerox 1110, including eye irritation, which was reported in 1964
(Tr. 140-141). Dr. Vinegar interpreted the results as yielding scores of only one for eye
conjunctival redness or swelling while a minimum score of at least two is required of
conjunctival swelling or redness to be deemed a "positive reaction" under 16
C.F.R. § 1500.42 (Ex. C-4; Tr. 140-143). See 16 C.F.R. § 1500.42, test for
eye irritants. She was of the opinion, therefore, that azelaic acid was not an
irritant as defined under the Hazard Communication Standard (Tr. 144). The
Secretary's compliance officer acknowledged that he had not read any of the underlying
studies reported by Patty's nor other scientific studies (Tr. 93-95). The record as
a whole fails to establish that azelaic acid is a chemical hazard as defined in the HCS.
Although Emerox 1110 contains 80 percent azelaic acid, the revised MSDS shows it also contains 1.1 percent to 1.3 percent adipic acid (1, 6-- Hexanedioic acid) which is also designated an "irritant" in Section II of that document (Ex. C-6). Patty's reports that adipic acid "produces severe eye irritation in rabbits" and no evidence to the contrary was offered (Ex. C-5, p. 4945; Tr. 160). Dr. Vinegar concedes that adipic acid by itself might cause problems with the eyes (Tr. 162).
An examination of the evidence and the standard compels the conclusion that Emerox 1110 as a whole is not a hazardous chemical within the meaning of the HCS. The section of the standard which requires a hazard determination, 29 C.F.R. § 1910.1200(d), requires chemical manufacturers and importers to evaluate the chemicals manufactured or imported by them to determine if any of the chemicals are hazardous as defined by the HCS. Chemicals appearing on named lists are established as hazardous. Neither azelaic acid or other chemicals in Emerox 1110 appear on the lists. If not on a list, a manufacturer may refer to reported scientific studies or conduct such studies to determine whether a chemical is hazardous.
Dr. Vinegar, respondent's expert witness, testified that a scientific study has been made of Emerox 1110 as a whole under conditions equivalent to those described in the HCS (Tr. 141). The study was conducted in August 1964 by Hill Top Research Institute, Inc., Miamiville, Ohio (Ex. R-4). Dr. Vinegar described the results of the tests as follows (Tr. 142-143).
In 16 CFR 1500.42, which used the same scoring method as this test did, in order for a material to be considered to have a positive reaction in the rabbit's eye, they must score at least a one for a cornea effect, corneal capacity, or it must score at least a one for iritis, which is irritation to the iris, or it must score at least a two for conjunctival redness or at least a two in conjunctival swelling. These rabbits, at most, showed only a score of one for conjunctival redness or swelling. So, it was considered they were not showing a positive reaction as defined under 16 CFR 1500.42.
Dr. Vinegar testified that the composition of Emerox 1110 has not been changed since 1964 (Tr. 161). Therefore, the product, when tested as a whole, was shown not to be a hazardous chemical although it contains a small percentage of adipic acid. The evidence fails to establish that Emerox 1110 is a hazardous chemical within the meaning of the HCS.
The Secretary contends that an "appropriate hazard warning" on labels required by 29 C.F.R. § 1910.1200 must include the target organs for any hazardous chemical. His position is set forth in a compliance directive designated as CPL2-2.38A (Ex. C-3, C-4; Tr. 26-30).
As the five labels listed in item 1(a) do not state the target organs, they were found inadequate (Tr. 43-44). Industrial Hygienist Sweeney explained the labeling deficiency as follows (Tr. 45-46):
A. In OSHA's definition of health hazard, which appears in the Hazard Communication Standard, Standard, [sic] there are nine target organs that are listed, and there are six hazard properties that are listed. As a minimum, what OSHA is looking for on container labels is a linking of which hazard can occur to which target organ.
More specifically, Sweeney explained the alleged defect in the labels as follows (Tr. 45):
A. Yes, this label does indicate that this
product is capable of causing irritation, but it does not specify that the eyes, the skin
and the mucous membrane or the respiratory tract are the target organs which can be
affected by this product.
Four of the labels, Emery 658, Emersol 6357, Emery 1202 and Emery 878, contain similar warnings[[8/]] (Ex. C-1).
Industrial Hygienist Sweeney acknowledged that, if the warning was appropriate for one label, it was appropriate for all four (Tr. 82-86). Emerox 1110 Azelaic Acid is found not be a hazardous chemical within the meaning of the HCS so the allegation that its label was inadequate is dismissed.
In determining what is an appropriate warning, it is useful to examine the purpose and scheme of the hazard communication standard. It was found that the full disclosure of information by manufacturers regarding the hazardous properties of chemicals was essential to enable "downstream" employers to develop effective training programs and provide employees with sufficient information to protect their own health. That is based on the concept that informed and trained employers and employees will use the information to make intelligent decisions concerning the use and handling of a product.
The standard, therefore, requires that appropriate hazard warnings be stated on the labels of hazardous chemicals. Complainant has found that general warnings become meaningless and are ignored by employees (Tr. 79). Therefore, warnings such as "do not get in eyes" and "avoid breathing vapor" are not deemed appropriate (Tr. 45-47). The labels of the products listed in item 1(a)--(e) contain such general statements as "causes severe burns, may be harmful if absorbed through the skin" and "do not get in eyes, on skin, or clothing." Mr. Sweeney testified that the labels of the four corrosive products did not meet the requirements of the HCS, because they did not identify the eyes as a target organ and an irritant to the skin and respiratory tract (Tr. 44-45). The Secretary points out that the valid scientific information is contained on the MSDS to warrant such warning on the labels. Respondent argues that, as the HCS is a performance standard, considerable latitude is afforded the employer to determine what warning is "appropriate" (Tr. 70, 79).[[9/]] Respondent notes that the MSDS contains the complete information regarding the product and that the label is not intended to convey all the data shown on the MSDS. That approach is approved in the preamble to the HCS, so the issue in this case is whether the labels in question contain the acceptable minimum information not whether they show all the available information. Emery points to the definition of corrosives as "a chemical that causes visible destruction of, or irreversible alterations in, living tissue by chemical action at the site of contact" [Appendix A(2)] and argues that such destruction occurs at any point of contact and a general warning is justified. Conversely, the Secretary contends that the identification of the target organs is an essential minimum requirement of an appropriate warning. In support of his position, the Secretary relies upon Appendices A and B to the standard and OSHA's policy directive at CPL2-2.38 (Exs. C-3, C-4). An examination of the foregoing documents compel the conclusion that labels are required to contain a statement identifying the target organs.
Appendix A, which is a mandatory portion of the HCS, states as follows:
Although safety hazards related the physical
characteristics of a chemical can be objectively defined in terms of testing requirements
(e.g. flammability), health hazard definitions are less precise and more subjective.
Health hazards may cause measurable changes in the body--such as decreased
pulmonary function. These changes are generally indicated by the occurrence of signs
and symptoms in the exposed employees--such as shortness of breath, a non-measurable,
subjective feeling. Employees exposed to such hazards must be apprised of
both the change in body function and the signs and symptoms that may occur to signal that
change. (Emphasis supplied.)
Section 1910.1200, Appendix A, paragraph 7, contains a statement and accompanying chart [[10/]] as follows:
7. Target organ effects. The
following is a target organ categorization of effects which may occur, including examples
of signs and symptoms and chemicals which have been found to cause such effects.
These examples are presented to illustrate the range and diversity of effects and hazards
found in the workplace, and the broad scope employers must consider in this area, but are
not intended to be all-inclusive.
|a.||Hepatotoxins: ..................................||Chemicals which produce liver damage.|
|Signs and Symptoms: .................||Jaundice; liver enlargement.|
|Chemicals: ..................................||Carbon tetrachloride; nitrosamines.|
|b.||Nephrotoxins: ..................................||Chemicals which produce kidney|
|Signs and Symptoms: .................||Edema; proteinuria.|
|Chemicals: ..................................||Halogenated hydrocarbons; uranium.|
|c.||Neurotoxins: ....................................||Chemicals which produce their primary|
|toxic effects on the nervous system.|
|Signs and Symptoms: .................||Narcosis; behavioral changes;|
|decrease in motor functions.|
|Chemicals: ..................................||Mercury; carbon disulfide.|
|d.||Agents which act on the blood||Decrease hemoglobin function; deprive|
|or hemtopoietic system:||the body tissues of oxygen.|
|Signs and Symptoms: .................||Cyanosis; loss of consciousness.|
|Chemicals: ..................................||Carbon monoxide; cyanides.|
|e.||Agents which damage the lung:.......||Chemicals which irritate or damage|
|the pulmonary tissue.|
|Signs and Symptoms: .................||Cough; tightness in chest; shortness|
|Chemicals: ..................................||Silica; asbestos.|
|f.||Reproductive toxins: ........................||Chemicals which affect the|
|reproductive capabilities including|
|chromsomal damage (mutations) and|
|effects on fetuses (teratogenesis).|
|Signs and Symptoms: .................||Birth defects; sterility.|
|Chemicals: ..................................||Lead; DBCP.|
|g.||Cutaneous hazards: ........................||Chemicals which affect the dermal|
|layer of the body.|
|Signs and Symptoms: .................||Defatting of the skin; rashes;|
|Chemicals: ..................................||Ketones, chlorinated compounds.|
|h.||Eye hazards: ...................................||Chemicals which affect the eye or|
|Signs and Symptoms: .................||Conjunctivitis; corneal damage.|
|Chemicals: ..................................||Organic solvents; acids.|
The inclusion of such specialized and detailed information in the standard indicates the importance that the Secretary attached to the information and it strongly supports the Secretary's position that it was information required to be placed on the labels. It demonstrates that the Secretary believes such information to be essential to meet the purposes and goals of the HCS. The absence of such data would deprive downstream employers and employees of important information. This interpretation is clearly set forth in the Secretary's policy directive, CPL2-2-38, which states as follows (Ex. C-3, pp. A6-7; also see exh. C-4, p. 11):
The "hazard warning" must convey the hazard of the chemical. This is intended to be specific information regarding the hazard--the specific hazards indicated in the standard's definitions for "physical" and "health" hazards would be appropriate. Phrases such as "caution", "danger", or "harmful if inhaled", generally do not meet the intent of the standard by themselves. The definition of "hazard warning" states that the warning must convey the hazard of the chemical. If, when inhaled, the chemical causes lung damage, then that is the appropriate warning. Lung damage is the hazard, not inhalation. There are some situations where the specific target organ effect is not known. Where this is the case, the more general warning statement would be permitted. For example, of the only information available is an LC50 test result, "harmful if inhaled" may be appropriate.
As the injurious effects on specific organs are known, the general warning would not be applicable in this case. Of course, the directive is not a part of the standard; but it does show how the Secretary has consistently interpreted the HCS.
In the instant case, an appropriate hazard warning would include a statement such as suggested by Industrial Hygienist Sweeney that the products cause severe burns to the eyes (Tr. 78). The scientific studies justify the warning proposed and the HCS requires it. As the labels of the four corrosive chemicals, Emery 658, Emersol 6357, Emery 1202 and Emery 878 did not provide the required information, a violation of 29 C.F.R. § 1910.1200(f)(1)(ii) has been established as alleged in item one.
Items two, three and four allege that the material safety data sheet for Emerox 1110 was deficient in that it failed to list ingredients determined to be health hazards, failed to list some of the physical or chemical characteristics and failed to provide complete first aid information.
Having determined that the evidence failed to establish that Emerox 1110 was a hazardous chemical, it follows that it did not violate the standard as alleged in items two, three and four.
FINDINGS OF FACT
1. Respondent is an employer who produces chemical products for sale to manufacturers.
2. Respondent has adopted a hazard determination review procedure for its chemical products.
3. Respondent has adopted a MSDS preparation and review program for its chemical products.
4. Respondent's MSDS preparation and review
program is independent of whether those products are "hazardous chemicals" under
5. Four corrosive products produced by respondent, Emery 658, Emery 878, Emersol 6357, and Emery 1202, failed to list the target organs on labels.
6. The four products listed in paragraph five above are particularly harmful to the eyes and an appropriate hazard warning should have mentioned that fact.
7. Emerox 1110 Azelaic Acid was tested as a whole to determine whether it is corrosive or an irritant to humans.
8. Emerox 1110 Azelaic Acid is not corrosive or an irritant to humans.
9. Azelaic acid is the result of a chemical
CONCLUSIONS OF LAW
1. Respondent is an employer subject to the hazard communication standard.
2. The HCS requires that the labels of hazardous chemicals identify the target organs.
3. Respondent violated 29 C.F.R. § 1910.1200(f)(1)(ii) by failing to list the target organs on the labels of Emery 658, Emersol 6357, Emery 1202 and Emery 878 as alleged in item one of the citation.
4. Emerox 1110 Azelaic Acid is not a "hazardous chemical" within the meaning of the HCS.
5. Respondent did not violate 29 C.F.R. §
1910.1200(g)(2)(ii), 29 C.F.R. § 1910.1200(g)(2)(i)(C)(1) and 29 C.F.R. §
1910.1200(g)(2)(x) as alleged in items two, three and four of the citation.
It is ORDERED:
1. Item one of the citation is affirmed as an other than serious violation.
2. Items two, three and four of the citation are vacated. Dated this 4th day of May, 1987.
JOE D. SPARKS
[[1/]] Complainant also amended item three of the citation to refer to Section VI rather than Section IV of the MSDS sheet (Tr. 6).
[[2/]] For a thorough discussion of the purpose, approach and organization of the Hazard Communication Standard, see Judge Burroughs' decision in Hilton-Davis Chemical Co., ___ OSAHRC ___ ___ BNA OSHC ___, ___ CCH OSHD ¶ ___ (No. 86-494, January 30, 1987).
[[[3/]] The five products alleged to lack appropriate hazard warnings on the labels are Emery 658, Emery 878, Emersol 6357, Emery 1202, and Emerox 1110.
[[4/]] Section 1910.1200(f)(1) of 29 C.F.R. provides as follows:
(1) The chemical manufacturer, importer or
distributor shall ensure that each container of hazardous chemicals leaving the workplace
is labeled, tagged or marked with the following information:
(i) Identity of the hazardous chemical(s);
(ii) Appropriate hazard warnings; and,
(iii) Name and address of the chemical manufacturer, importer, or other responsible party.
[[5/]] A health hazard is defined in 29 C.F.R. §
1910.1200(c) as follows:
"Health hazard" means a chemical for which there is statistically significant evidence based on at least one study conducted in accordance with established scientific principles that acute or chronic health effects may occur in exposed employees. The term "health hazard" includes chemicals which are carcinogens, toxic or highly toxic agents, reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins, nephrotoxins, neurotoxins, agents which act on the hematopoietic system, and agents which damage the lungs, skin, eyes, or mucous membranes. Appendix A provides further definitions and explanations of the scope of health hazards covered by this section, and Appendix B describes the criteria to be used to determine whether or not a chemical is to be considered hazardous for purposes of this standard.
[[6/]] Emery points out that the revised MSDS for Emerox 1110 was filed only after the compliance officer had contacted the company about the ingredients contained in the product. It implies that designating azelaic and adipic acids as irritants was the suggestion of the compliance officer but does not deny that Emerox 1110 contains the ingredients in the amounts stated (Exs. C-2(e), C-6; Tr. 21, 59-60). It is also noted that the original MSDS was prepared by a member of a technical group, who was not a toxicologist and did not consult with Emery's expert toxicologist (Tr. 134). The other four MSDS's were prepared by Mr. Scholssman and no problem as to them was raised by the Secretary (Tr. 50). Emery prepares an MSDS for its chemical products whether or not a product is a hazardous chemical.
[[7/]] Appendix A, Section 4, of the HCS states as follows:
4. Irritant: A chemical, which is not corrosive, but which causes a reversible inflammatory effect on living tissue by chemical action at the site of contact. A chemical is a skin irritant if, when tested on the intact skin of albino rabbits by the methods of 16 CFR 1500.41 for four hours exposure or by other appropriate techniques, it results in an empirical score of five or more. A chemical is an eye irritant if so determined under the procedure listed in 16 CFR 1500.42 or other appropriate techniques.
Section 1500.41 of 16 C.F.R. provides as follows:
Method of testing primary irritant substances.
Primary irritation to the skin is measured by a patch-test technique on the abraded
and intact skin of the albino rabbit, clipped free of hair. A minimum of six
subjects are used in abraded and intact skin tests. Introduce under a square patch, such
as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter
(in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test
substance. Dissolve solids in an appropriate solvent and apply the solution as for
liquids. The animals are immobilized with patches secured in place by adhesive tape.
The entire trunk of the animal is then wrapped with an impervious material, such as
rubberized cloth; for the 24-hour period of exposure. This material aids in
maintaining the test patches in position and retards the evaporation of volatile
substances. After 24 hours of exposure, the patches are removed and the resulting
reactions are evaluated on the basis of the designated values in the following table:
* * *
Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.
[[8/]] The label for Emery 658 states as follows:
EMERY 658 CAPRYLIC-CAPRIC ACID
DANGER! CAUSES SEVERE BURNS. MAY BE HARMFUL IF ABSORBED THROUGH THE SKIN.
DO NOT GET IN EYES, ON SKIN, ON CLOTHING.
AVOID BREATHING VAPOR.
KEEP CONTAINER CLOSED.
USE ADEQUATE VENTILATION.
WASH THOROUGHLY AFTER HANDLING.
IN CASE OF CONTACT WITH EMERY 658 RINSE AFFECTED AREA
IMMEDIATELY WITH LARGE AMOUNTS OF COOL WATER.
IN CASE OF SWALLOWING DO NOT INDUCE VOMITING.
GET IMMEDIATE MEDICAL ATTENTION FOR ANY CONTACT WITH EMERY 658.
SEE MATERIAL SAFETY DATA SHEET FOR FURTHER INFORMATION. FOR EMERGENCY ASSISTANCE, CALL CHEMTREC 800-424-9300.
[[9/]] OSHA's compliance directive, CPL2-2.38 paragraph .7C, which provides guidelines for its enforcement policy, states as follows:
The standard allows considerable flexibility in
format and content of labels, as long as the minimum information requirements are met.
(Ex. C-4 p. 11).