Fatty acids, tallow, zinc salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004. In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

other: CIR Cosmetic Ingredient Revie, peer-reviewed in EU RAR

Title:

Submission of data by CTFA. Unpublished safety data on the Lithium Stearate group. Consumer Product Testing Co., Inc. Final Report Zinc Stearate

Author:

Penick, S.B. et al.

Year:

1977

Bibliographic source:

Busch, J.T., CIR Cosmetic Ingredient Review (1982). Int J Toxicol 1 (2), 143-177.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize et al. (1944) Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377.

Principles of method if other than guideline:

The test item was applied under occlusive conditions to the abraded and intact skin of rabbits for 24 hours. The method of Draize (Draize, J.H., Woodard, G., and Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes, J. Pharmacol. Exp. Ther. 82, 377.) was used.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

91051-01-3

Cas Number:

91051-01-3

IUPAC Name:

91051-01-3

Constituent 2

Reference substance name:

Fatty acids, C16-18, zinc salts

EC Number:

293-049-4

EC Name:

Fatty acids, C16-18, zinc salts

IUPAC Name:

293-049-4

Details on test material:

- Name of test material (as cited in study report): zinc stearate
Substances named zinc stearate or zinc distearate are considered equal to substance fatty acid, C16-18, zinc salts. Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051- 01-3 is a more exact fit with commercial zinc stearate (c.f. EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN, page 7).
No further information on the test material was stated.

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Albino rabbits were used.
No further infromation on the test animals was stated.

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/kg zinc distearate was applied undiluted
- Concentration: 100 %
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:

24 hours

Observation period:

not stated

Number of animals:

6 rabbits

Details on study design:

It was stated that the method of Draize was used.
The test material was applied under occlusive conditions to the abraded and intact skin. The sites were unwrapped and examinedand scored for erythema and oedema at 24 and 72 hours.
No further information on the study design was stated,

Results and discussion

In vivo

Results

Irritation parameter:

other: Primary Irritation Index (PII)

Time point:

other: 24 and 72 hours

Score:

0

Remarks on result:

other: PII score of 0 translates into an overall irritation score of 0 according to OECD 404 (2002). Zinc stearate was not irritating

Irritant / corrosive response data:

Zinc stearate was not irritating

Other effects:

not stated

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Zinc stearate was not irritating.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.

This conclusion is in accordance with EU RAR.
Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004:
"Limited data on zinc distearate indicate no skin and eye irritating potential. Based on the accepted derogation and the fact that both zinc phosphate and zinc oxide is not skin irritating, it is consequently concluded that zinc distearate is not likely to have skin irritation potential and, therefore does not need to be classified/labelled. This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic preparations is not associated with irritation in humans."