Registration Dossier
Registration Dossier
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EC number: 229-657-3 | CAS number: 6641-64-1
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 from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- acute dermal toxicity for CAS NO: 88-74-4
- Author:
- IFA GESTIS
- Year:
- 2 017
- Bibliographic source:
- GESTIS SUBSTANCE Database (information system in hazardous substance of the Berufsgenossenscheftn).2017
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For SIAM 13, CAS no: 88-74-4
- Author:
- OECD SIDS
- Year:
- 2 001
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 13, Bern, Switzerland, 6-9 November 2001
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 2-nitroaniline was performed in guinea pig by Guinea pig maximization test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- 2- Nitroaniline
- Cas Number:
- 88-74-4
- Molecular formula:
- C6H6N2O2
- IUPAC Name:
- 2- Nitroaniline
- Details on test material:
- - Name of test material: o-Nitroaniline
- IUPAC name: 2-Nitroaniline
- Molecular formula: C6H6N2O2
- Molecular weight: 138.125 g/mol
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: o-Nitroaniline
- IUPAC name: 2-Nitroaniline
- Molecular formula: C6H6N2O2
- Molecular weight: 138.125 g/mol
- Substance type: Organic
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)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- 1st: Induction 5 % active substance intracutaneous
2nd: Induction 50 % active substance occlusive epicutaneous
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- 50 % active substance occlusive epicutaneous
- No. of animals per dose:
- Total:30
Test group:20
Control:10 - Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 1st: Induction 5 % active substance intracutaneous
2nd: Induction 50 % active substance occlusive epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available
- Concentrations: 50 % active substance occlusive epicutaneous
- Evaluation (hr after challenge): No data available - Challenge controls:
- yes
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 50 % active substance occlusive epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No sensitization reaction observed after challenge application,
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- 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 2-nitroaniline (88-74-4) was considered to be not skin sensitizing in guinea pig.
- Executive summary:
The skin sensitization study of 2-nitroaniline(88-74-4) was performed byguinea pig maximization method using OECD guideline 406 on guinea pig.The 30 animals were classified into two groups, test group 20 were as in control group 10 animals.
In induction phase, first inductiongiven by intracutaneous route in concentration 5 % while in 2nd Induction 50 % active substance as occlusive epicutaneous applied .Challenge given using 50% concentration of active substance by epicutaneous route as occlusive patch. No skin sensitization was observed after the challenge application Hence2-nitroaniline(88-74-4) was considered as not skin sensitizing in guinea pig.
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