Registration Dossier
Registration Dossier
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EC number: 219-989-7 | CAS number: 2592-95-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
Data source
Reference
- Reference Type:
- other: Secondary literature
- Title:
- Benzotriazoles - Evaluation of health hazards and proposal of health based quality criteria for soil and drinking water
- Author:
- Division of Toxicology and Risk Assessment -National Food Institute, Technical University of Denmark
- Year:
- 2 013
- Bibliographic source:
- The Danish Environmental Protection Agency, 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The skin sensitization study of the test chemical was assessed in guinea-pigs.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Benzotriazole
- EC Number:
- 202-394-1
- EC Name:
- Benzotriazole
- Cas Number:
- 95-14-7
- Molecular formula:
- C6H5N3
- IUPAC Name:
- 1H-Benzotriazole
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Benzotriazole
- Molecular formula: C6H5N3
- Molecular weight: 119.124 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1% of benzotriazole
- Day(s)/duration:
- 2 weeks
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: saline
- Concentration / amount:
- 0.1% of benzotriazole
- Day(s)/duration:
- 2 weeks
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petroleum
- Concentration / amount:
- 30% solution
- Day(s)/duration:
- 1 week
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Group of ten male and ten female guinea pigs
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: several
- Exposure period: 2 weeks
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: 2 weeks
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: After 2 weeks
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: 0.1%
C.RE-CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: after 1 week
- Exposure period: 24-48 hr
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: 30% solution in petroleum
- Evaluation (hr after challenge): 24-48- hour - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: Re-Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% solution in petroleum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reactions indicative of sensitisation were found.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- No skin reactions indicative of sensitisation were found. Thus, the the test chemical can be considered to be not a skin sensitizer.
- Executive summary:
The skin sensitization study of the test chemical was assessed in guinea-pigs.Group of ten male and ten female guinea pigs were given several intra-dermal injections of 0.1% of benzotriazole in saline together with an adjuvant. This was followed 2 weeks later by a challenge intra-dermal injection using the same concentration and, after a further 1 week, a 24-48- hour covered dermal application using a 30% solution in petroleum.
No skin reactions indicative of sensitisation were found. Thus, the the test chemical can be considered to be not a skin sensitizer.
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