Registration Dossier
Registration Dossier
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EC number: 209-980-6 | CAS number: 600-00-0
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:
- 2 002
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Ethyl 2-bromo-2-methylpropionate
- EC Number:
- 209-980-6
- EC Name:
- Ethyl 2-bromo-2-methylpropionate
- Cas Number:
- 600-00-0
- Molecular formula:
- C6H11BrO2
- IUPAC Name:
- ethyl 2-bromo-2-methylpropionate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: corn oil for intradermal injections and aceton for topical application
- Concentration / amount:
- 10 % w/w in corn oil (intradermal injections) and 100% w/w undiluted (topical application) : induction
100% w/w undiluted (topical application) : challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: corn oil for intradermal injections and aceton for topical application
- Concentration / amount:
- 10 % w/w in corn oil (intradermal injections) and 100% w/w undiluted (topical application) : induction
100% w/w undiluted (topical application) : challenge
- No. of animals per dose:
- 30 (15 males / 15 femals) for the main test
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- grade 1 or 2 on 4
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: grade 1 or 2 on 4. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- grade 1, 2 or 3 on 4
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- Dryness of the skin have masked the scoring of erythema in 7/20 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: grade 1, 2 or 3 on 4. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: Dryness of the skin have masked the scoring of erythema in 7/20 animals.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- grade 1 or 2 on 4
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: grade 1 or 2 on 4. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- grade 1 or 2 on 4
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: grade 1 or 2 on 4. No with. + reactions: 17.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under our experimental conditions, the test item Ethyl 2-bromoisobutyrate should be considered as a skin sensitizer.
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