Registration Dossier
Registration Dossier
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EC number: 202-451-0 | CAS number: 95-78-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritive database
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritative database
- Title:
- Skin sensitization study of test chemcial in guinea pig.
- Author:
- IFA GESTIS
- Year:
- 2 018
- Bibliographic source:
- IFA GESTIS,2018
- Reference Type:
- other: Secondary source
- Title:
- IUCLID DATASET
- Author:
- EUROPEAN COMMISSION – European Chemicals Bureau
- Year:
- 2 000
- Bibliographic source:
- IUCLID DATASET, EUROPEAN COMMISSION – European Chemicals Bureau, 18–FEB–2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Skin sensitization study of test chemical was performed in guinea pig by Buehler test
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- 2-Chloro-4-nitroaniline
- Cas Number:
- 121-87-9
- Molecular formula:
- C6H5CIN2O2
- IUPAC Name:
- 2-Chloro-4-nitroaniline
- Details on test material:
- - Name of test material (as cited in study report): 2-Chloro-4-nitroaniline
- Molecular formula: C6H5CIN2O2
- Molecular weight: 172.57g /mole
- Substance type: organic
- Physical state: No data available
- Purity :No data available
- Impurities (identity and concentrations): No data available
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- No data available
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- No sensitization reaction observed after challenge application,
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No sensitization reaction observed after challenge application.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- According to the guinea pig maximization method, the test chemical was considered to be not skin sensitizing.
- Executive summary:
The skin sensitization study of test chemical was performed by Buehler test using OECD guideline 406 on guinea pig.No skin sensitization was observed after the challenge application.Hence,test chemical was considered as not skin sensitizing in guinea pig.
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