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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.
Cross-reference
Reason / purpose:
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 Unpublished safety data on the Lithium Stearate group.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

Principles of method if other than guideline:
A single 1-hr exposure of rats to 200 mg/l zinc stearate. The rats were observed for two weeks.
GLP compliance:
no
Test type:
other: not stated

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
Albino rats were used.
No further information on the test animals was stated.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Rats were exposed to zinc stearate for one hour.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
200 mg/l zinc stearate (Chamber concentration)
No. of animals per sex per dose:
10 rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: moratlity was reported.
No further information on the study design was stated.
Statistics:
not stated

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 200 other: mg/l
Based on:
test mat.
Exp. duration:
1 h
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 50 other: mg/l
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: This LC50 was recalculated from the LC50 (1 hr) by using Haber's law.
Mortality:
1/10 rats died during the 2-week observation period.
Clinical signs:
other: All animals appeared depressed for the first six hours. From 24 hrs. until day 14, they appeared normal.
Body weight:
not stated
Gross pathology:
not stated
Other findings:
not stated

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 (4 h) > 50 mg/l (recalculated from LC50 (1h) by using Haber's law)
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic via the inhalation route.
According to the Regulation (EC) No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the inhalation route.

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