N-(4-aminophenyl)aniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study comparable to guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Reference 2

Reference Type:

secondary source

Title:

Summary with cover letter dated 10/18/88; NTIS/OTS 516609, Doc I.D. 89-890000009 (1988)

Author:

EPA-OTS

Year:

1988

Bibliographic source:

Monsanto Co. (1984) Acute toxicity/irritation studies with 4-aminodiphenylamine (4-ADPA). Study BD-84-077 Summary with cover letter dated 10/18/88; NTIS/OTS 516609, Doc I.D. 89-890000009 (1988)

Reference 3

Reference Type:

publication

Title:

Acute toxicologic evaluation of 4-aminodiphenylamine

Author:

Randall, D.J. and Bannister R.M.

Year:

1990

Bibliographic source:

Acute Toxicity Data 1: 63 - 64

Materials and methods

Principles of method if other than guideline:

Method: other: comparable to OECD TG 402 (EPA guideline: Section 81-2, acute dermal toxicity study November 1982, TSCA: health effects test guideline EPA August 1982,: acute exposure, dermal toxicity)

GLP compliance:

yes

Test type:

other: acute dermal toxicity study

Test material

Test material information

Constituent 1

Reference substance name:

N-(4-aminophenyl)aniline

EC Number:

202-951-9

EC Name:

N-(4-aminophenyl)aniline

Cas Number:

101-54-2

Molecular formula:

C12H12N2

IUPAC Name:

N1-phenylbenzene-1,4-diamine

Details on test material:

IUCLID4 Test substance: other TS: purity 98.9 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Duration of exposure:

approx. 24 h

Doses:

5000

No. of animals per sex per dose:

5 per dose and sex

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: sporadic occurrence of nasal and ocular discharge and single occurrence of red and/or swollen eyes

Any other information on results incl. tables

RS-Freetext:
Dose range finding study:

no mortality seen up to highest dose evaluated

MORTALITY main study: 
- Number of deaths at the single dose: none
CLINICAL SIGNS: 
only a few animals showed reduced food consumption nasal and ocular discharge and single occurrences of red and/or swollen eyes, were observed

Body weight:

most animals exhibited little or no weight change at day 7, but all gained weight between day 7 and 14.

Pharmacologic and toxicologic signs: most animals were free of significant signs of systemic toxicity, although some occurences of nasal discharge were seen as were single occurences of red and or swollen eyes, food consumption decrease and ocular discharge. One animal exhibited a swollen left eye and a red nictitating membrane in the same eye during the day of dosing and or the day after dosing.

POSTMORTEM OBSERVATION: 

Observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of the test substance 4-ADPA was evaluated with New Zealand White rabbits in a GLP and Guideline study. No mortality was observed in the dose range finding study up to 5000 mg/kg bw. Thus, in the main study five male and five female rabbits were treated with 5000 mg/kg bw test substance for 24 hours, followed by a 14 d observation period. All animals survived throughout the study. Therefore, the dermal LD50 of 4-ADPA in rabbits is greater than 5000 mg/kg bw. Most animals were free of significant signs of systemic toxicity, although some occurrence of nasal discharge were seen as were single occurrence of red and/or swollen eyes, food consumption decrease and ocular discharge. One animal exhibited a swollen left eye and a red nictitating membrane in the same eye during the day of dosing and or the day after dosing (Monsanto 1984).