Registration Dossier
Registration Dossier
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EC number: 600-198-4 | CAS number: 101377-47-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
- Type of study:
- split adjuvant test
Test material
- Reference substance name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- EC Number:
- 600-198-4
- Cas Number:
- 101377-47-3
- Molecular formula:
- C16H15N3F2Si
- IUPAC Name:
- bis(4-fluorophenyl)methyl(4H-1,2,4-triazol-4yl-methyl)silane
- Details on test material:
- - Purity: R7623 Technical, solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqueous methyl cellulose 1%
- Concentration / amount:
- - Induction: each animal received a dose of 50% test substance
- Challenge: each received the three test concentrations (5%, 10% and 50% w/w) and control dose in separate areas on the shaved back of the animal
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: aqueous methyl cellulose 1%
- Concentration / amount:
- - Induction: each animal received a dose of 50% test substance
- Challenge: each received the three test concentrations (5%, 10% and 50% w/w) and control dose in separate areas on the shaved back of the animal
- No. of animals per dose:
- 20 animals, each treated with the same 3 test concentrations and control
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- all
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: all. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- all
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: all. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
- Executive summary:
The test substance suspended in aqueous methy cellulose 1% at several concentrations (50%, 10% and 5%) and administered epicutaneously to guinea pigs in the challenge phase, resulted in no skin reaction in any of the experimental nor control animals. No signs of systemic toxicity were observed in any of the animals during the study period.
The test results indicate a sensitization rate of 0%. It is therefore improbable that the test substance has sensitizing properties.
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