Registration Dossier
Registration Dossier
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EC number: 262-774-8 | CAS number: 61417-49-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The target substance is a hydrolytically unstable organotitatnate with hydrolysis half-life estimated to be with 1 hr, and with hydrolysis products being identified to be 2-propanol, isostearic acid and titanium dioxide. Because of the rapid hydrolysis, the influence of the target substance is related to the hydrolysis products.
Isostearic acid is the major hydrolysis product of the target substance. It’s toxicity property is used for read-across based on weight of evidence method.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Isostearic acid
- Author:
- Cosmetic Ingredient Review
- Year:
- 1 983
- Bibliographic source:
- J. Am. Coll. Toxicol. Vol. 2, 7, 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of human data. Review of patch test data of humans following exposure
- GLP compliance:
- no
- Remarks:
- Non-GLP study that predates current guideline.
- Type of study:
- patch test
- Justification for non-LLNA method:
- Existing study conducted before REACH. Study conducted on human and adopted by peer-revieed journal.
Test material
- Reference substance name:
- Isooctadecanoic acid
- EC Number:
- 250-178-0
- EC Name:
- Isooctadecanoic acid
- Cas Number:
- 30399-84-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- 16-methylheptadecanoic acid
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 35%
- Day(s)/duration:
- 3 week
- No. of animals per dose:
- 168
- Details on study design:
- Test material was applied at 48h intervals, 3 times per week for 3 weeks on the back of the subjects. The test area was occluded for 24 h before removal, and washed with distilled water.
Test sites were read at 48 h. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 35 %
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 35%
- No. with + reactions:
- 0
- Total no. in group:
- 168
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- expert judgment
- Conclusions:
- Assessment of extensive human data showed that there is no indication of sensitisation protential.
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