Registration Dossier
Registration Dossier
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EC number: 265-004-9 | CAS number: 64665-57-2
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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study is available and assessed reliable and sufficient to meet the information requirements.
Test material
- Reference substance name:
- 4(or5)-Methyl-benzotriazole
- IUPAC Name:
- 4(or5)-Methyl-benzotriazole
- Reference substance name:
- Methylbenzotriazol
- IUPAC Name:
- Methylbenzotriazol
- Reference substance name:
- Methyl-1H-benzotriazole
- EC Number:
- 249-596-6
- EC Name:
- Methyl-1H-benzotriazole
- Cas Number:
- 29385-43-1
- Molecular formula:
- C7H7N3
- IUPAC Name:
- 4(or5)-methyl-1H-1,2,3-benzotriazole
- Test material form:
- other: granules
- Details on test material:
- - Name of test material (as cited in study report): Preventol CI 7-100
- Substance type: cylindrical granules
- Physical state: solid
- Analytical purity: 99.2 %
- Composition of test material, percentage of components: 40 % 4-Methylbenzotriazole, 60 % 5-Methylbenzotriazole
- Lot/batch No.: 868
- Storage condition of test material: 20 - 22.5 °C in the dark
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Kreis Pderborn, Germany
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: mean 352 g
- Housing: Makrolon cages type IV
- Diet: Altromin3022 ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2 °C
- Humidity (%): 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- intradermal induction: 5 %
epicutaneous induction: 50 %
Challenge: 6 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- intradermal induction: 5 %
epicutaneous induction: 50 %
Challenge: 6 %
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: yes:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal on start, epicutaneous one week later
- Test groups: 20 animals
- Control groups: 2*10 animals
- Site: on the back
- Frequency of applications: once intradermal, once epicutaneous
- Duration: 48 hours for epicutaneous
- Concentrations: 5 % and 50 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: on the back
- Concentrations: 6 %
- Evaluation (hr after challenge): 24 and 48 h after removal of bandage - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- No
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item Tolyltriazole did not show any signs of skin sensitation in the guinea pig in this study.
Historical data of positive control substances showed the sensitivity of the test performed in the labouratry
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