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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 is from collection of data .

Data source

Reference
Reference Type:
review article or handbook
Title:
Summary of Data for Chemical Selection – CAS no: 97-52-9 (2-Methoxy-4-nitroaniline)
Author:
U.S. National Toxicology Program (NTP)
Year:
2006
Bibliographic source:
Prepared for NCI to support chemical nomination by Technical Resources International, Inc. under contract no. N02-CB-07007, 2006

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
The skin sensitization study of 2-Methoxy-4-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:
Not specified.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report): 2-methyl-4-nitroaniline
- Molecular formula :C7H8N2O2
- Molecular weight :152.152 g/mole
- Substance type: organic
- Physical state:yellow powder
- Purity: No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
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: For intradermal injection: Alembicol D, a coconut oil triglyceride, For dermal application: Distilled Water
Concentration / amount:
For intradermal injection: 7.5 percent (w/w) solution in Alembicol D, a coconut oil triglyceride,
For dermal application:75% in Water
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75% and 40% in distilled water
No. of animals per dose:
No data available
Details on study design:
Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data available

- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: For intradermal injection: 7.5 percent (w/w) solution in Alembicol D, a coconut oil triglyceride,
For dermal application:75% in Water

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: 75% and 40% in distilled water
- Evaluation (hr after challenge): No data available
OTHER: No data available
Challenge controls:
No data available
Positive control substance(s):
no

Study design: in vivo (LLNA)

Statistics:
No data avaliable

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
75% and 40% in distilled water
No. with + reactions:
0
Clinical observations:
no evidence of sensitisation
Remarks on result:
no indication of skin sensitisation
Remarks:
Not skin sensitizing in guinea pig

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The skin sensitization study of 2-Methoxy-4-nitroaniline (99-52-9) was performed in guinea pig by Guinea pig maximization test . The test result was considered to be not sensitizing inguinea pig .
Executive summary:

The skin sensitization study of 2-Methoxy-4-nitroaniline(99-52-9) was performed in Dunkin Hartley guinea pig by Guinea pig maximization test.In induction phase,For intradermal injection7.5 percent (w/w) solution inAlembicol D, a coconut oil triglyceride and for dermal application 75% in Water concentration were used.In challenge phase 75% and 40% solution in distilled water was used .No evidence of sensitivity was noted. Hence it is considered that 2-Methoxy-4-nitroaniline(99-52-9) was not skin sensitizing in guinea pig.