Registration Dossier
Registration Dossier
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EC number: 204-289-6 | CAS number: 118-96-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- The study is non-LLNA as it is the only study already available based on literature already published.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975-1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Due to absence of information on number of animal reliability category according to Klimisch is 3 (red score). Evaluator proposal is 2 (“reliable with restrictions”) because number of animals in compliance with method can be various.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: maximization test described by magnusson and Kligman
- GLP compliance:
- no
- Remarks:
- The study was conducted in 1975 whereas OECD and EU Guidelines as well as GLP Principles were implemented in 1981 and 1988
- Type of study:
- other: guinea pig maximization test
- Justification for non-LLNA method:
- The study is non-LLNA as it is the only study already available based on literature already published.
Test material
- Reference substance name:
- TNT
- IUPAC Name:
- TNT
- Reference substance name:
- 2,4,6-trinitrotoluene
- EC Number:
- 204-289-6
- EC Name:
- 2,4,6-trinitrotoluene
- Cas Number:
- 118-96-7
- Molecular formula:
- C7H5N3O6
- IUPAC Name:
- 2-methyl-1,3,5-trinitrobenzene
- Details on test material:
- TNT was purchased from K&K Laboratories (Cleveland, Ohio). Purity >99%.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Group:
- test chemical
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Response: 40%, Sensitization: moderate
Any other information on results incl. tables
Bunber responding: 4/10
Response: 40%
Sensitization: moderate
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not sensitising according to Regulation (EC) no 1272/2008 (CLP).
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