Registration Dossier
Registration Dossier
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EC number: 252-669-5 | CAS number: 35674-68-1
Acute Toxicity: inhalation
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 (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1). 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 Unpublished safety data on the Lithium Stearate group.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:
- 1 977
- 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 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system 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: mortality: 1/10 rats; al animals appeared depressed for the first 6 hrs.. 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. (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1):
"Zinc distearate does not need to be classified on the basis of its acute toxicity according to the EC criteria."
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