Aniline

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and national standard methods (21 CFR 191.10) with acceptable restrictions (no data on purity, concentrations, exposure time, observation period, clinical signs and pathology)

Data source

Reference

Reference Type:

publication

Title:

Comparative acute effects of some chemicals on the skin of rabbits and guinea pigs.

Author:

Roudabush, R.L. et al.

Year:

1965

Bibliographic source:

Toxicology and Applied Pharmacology 7, 559-565

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 21 CFR 191.10

Deviations:

yes

Remarks:

only for rabbits; rabbits were not immobilized

Principles of method if other than guideline:

Acute dermal toxicity on rabbit skin according to US Regulation 21 CFR 191.10 with the exceptions that rabbits were not immobilized for 24 hours but were confined to cages, and the skin of all rabbits was abraded.
For both, rabbits and guinea pigs, a minimum of 3 dosages was employed, usually with 4 animals per dosage, and the LD50 was calculated by the method of Finney. Rubber dental dam or 5-mil fluorocarbon plastic sheeting was used as the sleeve material. The test compounds were applied undiluted to guinea pigs on a 1-inch square cellulose pad held onto the clipped and depilated intact abdomens or the clipped and depilated abraded backs.

GLP compliance:

no

Test type:

other: according to the US Federal Hazardous Substances Labeling Act (21 CFR 191.10).

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aniline

EC Number:

200-539-3

EC Name:

Aniline

Cas Number:

62-53-3

Molecular formula:

C6H7N

IUPAC Name:

aniline

Details on test material:

- Name of test material (as cited in study report): aniline
- Analytical purity: no data

Test animals

Species:

other: guinea pig, rabbit

Strain:

other: guinea pig: Hartley; rabbit: no data

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Guinea pig: Tumblebrook Farms, Brant Lake, New York; rabbit: not stated
- Weight at study initiation: guinea pig: 400 - 900 g; rabbit 1 - 4 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- % coverage: guinea pig: 1-inch square cellulose pad, rabbit: according to 21 CFR 191.10

Duration of exposure:

rabbit: not stated; according to US Regulation 21 CFR 191.10
guinea pig: not stated

Doses:

no data; a minimum of three doses was applied

No. of animals per sex per dose:

4

Control animals:

not specified

Statistics:

The LD50 was calculated according to the method of Finney.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 316 mg/kg bw

Remarks on result:

other: Guinea pig, intact skin

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 193 mg/kg bw

Remarks on result:

other: Guinea pig, abraded skin

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

836 mg/kg bw

Remarks on result:

other: rabbit, abraded skin

Mortality:

not reported

Clinical signs:

other: not reported

Gross pathology:

not reported

Any other information on results incl. tables

LD50 value were reported in mL/kg bw. Conversion into mg/kg bw was based on a density of 1.02 (Chapter 4.4 - Densitiy):

guinea pig, intact skin; LD50 1.29 ml/kg => 1316 mg/kg

guinea pig, abraded skin; LD50 2.15 ml/kg => 2193 mg/kg

rabbit, abraded skin; LD50 0.82 ml/kg => 836 mg/kg