Registration Dossier
Registration Dossier
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EC number: 203-697-1 | CAS number: 109-70-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
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
- Justification for non-LLNA method:
- The test was launched before the implementation of the LLNA method.
Test material
- Reference substance name:
- 1-bromo-3-chloropropane
- EC Number:
- 203-697-1
- EC Name:
- 1-bromo-3-chloropropane
- Cas Number:
- 109-70-6
- Molecular formula:
- C3H6BrCl
- IUPAC Name:
- 1-bromo-3-chloropropane
- Details on test material:
- Purity 99,8 %
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
- Vehicle:
- corn oil
- Concentration / amount:
- Preliminary test :
Intradermal injection : 0,1 mL/injection
Topical application : 50, 75 and 100% of the test item in Freund's complete adjuvant (FCA)/0,9% NACl(50/50, v/v)
Main test :
Intradermal injection : 0,1 mL/injection
Topical application : 50% of the test item in Freund's complete adjuvant (FCA)/0,9% NACl(50/50, v/v)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Preliminary test :
Intradermal injection : 0,1 mL/injection
Topical application : 50, 75 and 100% of the test item in Freund's complete adjuvant (FCA)/0,9% NACl(50/50, v/v)
Main test :
Intradermal injection : 0,1 mL/injection
Topical application : 50% of the test item in Freund's complete adjuvant (FCA)/0,9% NACl(50/50, v/v)
- No. of animals per dose:
- preliminary test : 3 males / 3 females
main test : 15 females
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- grade 1 on 3 : discrete erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: grade 1 on 3 : discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- grade 1 on 3 : discrete erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: grade 1 on 3 : discrete erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- grade 2 on 3 : moderate erythema associated with dryness of the skin
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: grade 2 on 3 : moderate erythema associated with dryness of the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the test item 1-bromo-3-chloropropane did not induce delayed contact hypersensitivity in guinea pigs. Therefore, the test item should not be considered as sensitizing.
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