Registration Dossier
Registration Dossier
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EC number: 202-534-1 | CAS number: 96-78-6
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
Reference
- Reference Type:
- secondary source
- Title:
- Classification/MAK value: 2,4-Diaminoanisole and 2,4-Diaminoanisole sulfate
- Author:
- DFG, German Research Foundation
- Year:
- 1 985
- Bibliographic source:
- The MAK Collection for Occupational Health and Safety, volume 6 Page No 149, 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of 2,4-diaminoanisole sulphate was performed by Magnusson and Kligman method.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- 2,4-diaminoanisole sulphate
- Cas Number:
- 39156-41-7
- Molecular formula:
- C7H10N2O.H2O4S
- IUPAC Name:
- 2,4-diaminoanisole sulphate
- Details on test material:
- - Name of test material (as cited in study report): 2,4-diaminoanisole sulphate
- Molecular formula: C7H10N2O.H2O4S
- Molecular weight: 236.246g/mole
- Substance type: Organic
- Physical state: : No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2,4-diaminoanisole sulphate
- Molecular formula: C7H10N2O.H2O4S
- Molecular weight: 236.246g/mole
- Substance type: Organic
- Physical state: : No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available
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:
- water
- Concentration / amount:
- 1) both undiluted and diluted 1:1 with Freund's adjuvant,
2)5 % w/v water solution of test compound
Epicutaneous induction 0.4 ml of a 50 % (w/v) aqueous solution of test material
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % (w/v) solution of test material
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 %
- No. of animals per dose:
- 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:10
- Control group: No data available
- Site: interscapular area.
- Frequency of applications: after 7 days
- Duration: 14 days
- Concentrations: I) intradermal Induction :
1) both undiluted and diluted 1:1 with Freund's adjuvant,
2)5 % w/v water solution of test compound
II) Epicutaneous induction 0.4 ml of a 50 % (w/v) aqueous solution of test material
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge:14 days
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: left flank
- Concentrations: 25 % (w/v) solution of test material
- Evaluation (hr after challenge): No data available
C. RECHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge:7 days
- Exposure period: No data available
- Test groups:10
- Control group: No data available
- Site: right flank
- Concentrations: 5 % test material
- Evaluation (hr after challenge): No data available - Challenge controls:
- No
- 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)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 25 % (w/v) solution of test material
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- Delayed contact hypersensitivity was seen in two animals out of 10
- Remarks on result:
- other: 2 animals showed positive skin reaction
- Reading:
- 2nd reading
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- No skin sensitization reaction observed except one animal showed delayed contact hypersensitivity
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- except one animal showed delayed contact hypersensitivity
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Delayed contact hypersensitivity was seen in two animals out of 10
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The 2,4-diaminoanisole sulphate (39156-41-7) was considered to be not sensitizing to guinea pig.
- Executive summary:
The skin sensitizing study of 2,4-diaminoanisole sulphate(39156-41-7) was carried out in guinea pig byMagnusson and Kligman methodin group of 10.Test material dissolved in water .intradermal induction was given as both undiluted and diluted 1:1 with Freund's adjuvant and5 % w/v water solution of test compound oninterscapular area.While epicutaneous induction0.4 ml of a 50 % (w/v) aqueous solutionof test material on same skin site(clipped free of fur) on an occlusive patch after 7 days.
An interval of 14 days animals were challenged by 25 % (w/v) solution oftest materialby topical application under occlusivepatch on left flank.
After one week second challenged given at dose5 % test materialsolution on right flank.Delayed contact hypersensitivity was seen in one animal. After the first challenge treatment, equivocal reactions were observed in two animalsTherefore, based on the results obtained, the2,4-diaminoanisole sulphate(39156-41-7)was considered to be not sensitizing to guinea pig.
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