4-nitro-o-toluidine

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 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

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

Test material information

Constituent 1

Reference substance name:

2-methyl-4-nitroaniline

Cas Number:

97-52-9

Molecular formula:

C7H8N2O2

IUPAC Name:

2-methyl-4-nitroaniline

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 chemical

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.