Registration Dossier
Registration Dossier
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EC number: 221-975-0 | CAS number: 3302-10-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- guinea pig maximisation test, unclear if according to guidelines
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study has been performed before REACH regulation came into force
Test material
- Reference substance name:
- 3,5,5-trimethylhexanoic acid
- EC Number:
- 221-975-0
- EC Name:
- 3,5,5-trimethylhexanoic acid
- Cas Number:
- 3302-10-1
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 3,5,5-trimethylhexanoic acid
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): 3,5,5-trimethylhexanoic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- no details provided
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- 1-5%
- Day(s)/duration:
- no data
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- not provided
- Day(s)/duration:
- no data
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- no data
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20-25
- Details on study design:
- no data
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Positive results have been shown for several substances, e.g. acrylic monomere or potassium dichromate
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: overall result
- Group:
- test chemical
- Dose level:
- pure substance
- Clinical observations:
- no data provided
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- no further information provided
- Reading:
- other: overall result
- Group:
- negative control
- Dose level:
- not indicated
- Clinical observations:
- no data provided
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: overall result
- Group:
- positive control
- Dose level:
- <=25%
- Clinical observations:
- no data provided
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Result: negative (no further details provided)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was reported to be not sensitising in this study.
- Executive summary:
The test substance was not sensitising in a guinea pig maximisation test (no details reported) (Cronin, 1994).
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