Registration Dossier
Registration Dossier
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EC number: 257-158-0 | CAS number: 51368-55-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Use of in-vitro methods instead of animal methods
Test material
- Reference substance name:
- Isopropyl 2-bromo-2-methylpropionate
- EC Number:
- 257-158-0
- EC Name:
- Isopropyl 2-bromo-2-methylpropionate
- Cas Number:
- 51368-55-9
- Molecular formula:
- C7H13BrO2
- IUPAC Name:
- isopropyl 2-bromo-2-methylpropionate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Remarks:
- Intradermal induction and topical challenge
- Concentration / amount:
- Intradermal induction : 5% v/v in arachid oil
Topical induction : undiluted
Topical challenge : 10 % and 5% v/v in arachid oil
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- arachis oil
- Remarks:
- Intradermal induction and topical challenge
- Concentration / amount:
- Intradermal induction : 5% v/v in arachid oil
Topical induction : undiluted
Topical challenge : 10 % and 5% v/v in arachid oil
- No. of animals per dose:
- 10 test and 5 control
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL of the vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 1 animal was found dead on day 25. As such spontaneous mortality is sometimes observed in thies species, it was not attributed to treatment.
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- see below
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- 30% sensibilisation rate in guinea pig skin
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: see below. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: 30% sensibilisation rate in guinea pig skin.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test, the test material was classified as a moderate sensitiser to guinea pig skin.
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