Fatty acids, C14-18 and C16-18-unsatd., zinc salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

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.

Justification for type of information:

Fatty acids, C14-18 and C16-18-unsatd., zinc salts (CAS 67701-12-6) is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) fatty acids based on structural similarity, water solubility and zinc content in a conservative, worst-case approach is assumed to adequately describe the toxicological potential of Fatty acids, C14-18 and C16-18-unsatd., zinc salts.

Acute toxicity is addressed with substance-specific information and data read-across from relevant zinc soaps (zinc salts of shorter-chained (C8, C12) and similar chained (C16-18) fatty acids) as well as supporting information from slightly soluble/insoluble zinc compounds. Thus, read-across of toxicological data of (i) zinc oxide; (ii) octanoic acid, zinc salt, basic; (iii) zinc dilaurate; and (iv) Fatty acids, C16-18, zinc salts is applied to Fatty acids, C14-18 and C16-18-unsatd., zinc salts.

Regarding acute dermal toxicity, a key study with the structurally similar substance Fatty acids, C16-18, zinc salts is available showing no acute dermal toxicity and an LD50 >2000 mg/kg bw. Thus, is is assumed that Fatty acids, C14-18 and C16-18 unsatd., zinc salt does not show dermal toxicity either.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

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 Unpublished safety data on the Lithium Stearate Group. Acute oral intubation, acute dermal toxicity, primary skin irritation and ocular irritation.

Author:

CTFA

Year:

1976

Bibliographic source:

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

Reference 2

Reference Type:

other: communication

Title:

Zinc stearate (10 %) in eye shadow 923-100

Author:

CIR Safety.org, Cosmetic Ingredient Review 1101 17th St. N. W. Suite 412 Washington D. C. 20036-4702, USA

Year:

2010

Bibliographic source:

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

Materials and methods

Principles of method if other than guideline:

10 % zinc stearate in eyeshadow form was applied dermally to rabbits.

GLP compliance:

not specified

Test type:

other: in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, zinc salts

EC Number:

293-049-4

EC Name:

Fatty acids, C16-18, zinc salts

Cas Number:

91051-01-3

Molecular formula:

Zn(C18H35O2)2 for C18 and Zn(C16H31O2)2 for C16

IUPAC Name:

Fatty acids, C16-18, zinc salts

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

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Rabbits were used.
No further information on the test animals was stated.

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 % zinc stearate in eyeshadow form was applied dermally to rabbits.
No further information on dermal exposure was stated.

Duration of exposure:

Not stated

Doses:

Not stated

No. of animals per sex per dose:

10 rabbits

Control animals:

not specified

Details on study design:

No information on the study design was stated.

Statistics:

Not stated.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was reported.

Clinical signs:

other: Not stated

Gross pathology:

Not stated

Other findings:

Not stated

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for 10 % zinc stearate in eye shadow form (formulation) is > 2000 mg/kg bw for rabbits.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified.

This conclusion is in accordance with the 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: "Zinc distearate does not need to be classified on the basis of its acute toxicity according to the EC criteria."