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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: Review
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Review of historical data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline required
Guideline:
other: Assessment
Test type:
other: Review

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: Estimated
Mortality:
No evidence of mortality from dermal contact
Clinical signs:
None reported
Other findings:
Local irritation noted in some sources of information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No evidence of dermal toxicity, although some local effects to the skin due to irritation. The supporting data is very weak, but there is considered to be no justification to perform new animal studies. A waiver is requested. The subtance is widely supplied ot the cosmetics industry and new testing has not been considered appropriate.

Read-across justified by statement claiming the data covers range of alklyimines; specifically, "sodium and potassium salts of N-alkyl
(C8-C18)-beta-iminodipropionic acid where the C8-C18 is linear and may be saturated and/or unsaturated, (CAS Reg. Nos. 110676-19-2, 3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1) [Ref 40 CFR Part 180, Federal Register Volume 76, number 24, 4 February 2011'

The only significant source of information found included the Industrial Bio-Test laboratories report on 10% Deriphat 160-C from 1963 (cited above) in which a 10% solution is dosed at up to 10.2 g/kg (1020 mg/kg actives) on rabbits with no adverse effects reported.

There is no evidence of dermal toxicity other than local irritant effects in any substances of this class.

The EPA review of Sodium and Potassium Salts of N-alkyl (C8-C18)-beta-iminodipropionic acid [2] concludes that there is low toxicity and in the opinion of the US EPA, no further testing is needed.
Executive summary:

References:

International Journal of Toxicology, 16 (Suppl) 1):1-9 1997

Cosmetic Ingredient Review, Meetings December 12 -13 2011

SSNA Inert Ingredients Human Health Risk Assessment, US Environmental Protection Agency report D365994, 10 June 2009

Read-across justified by statement claiming the data covers range of alklyimines; specifically, "sodium and potassium salts of N-alkyl (C8-C18)-beta-iminodipropionic acid where the C8-C18 is linear and may be saturated and/or unsaturated, (CAS Reg. Nos. 110676-19-2, 3655-00-3, 61791-56-8, 14960-06-6, 26256-79-1, 90170-43-7, 91696-17-2, and 97862-48-1) [Ref 40 CFR Part 180, Federal Register Volume 76, number 24, 4 February 2011'