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Toxicological information

Skin sensitisation

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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:
1985
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:
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
Name:
Unnamed
Type:
Constituent
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
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 group
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 group
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.