Benzenamine, reaction products with aniline hydrochloride and nitrobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 December 1992 to 18 January 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, reaction products with aniline hydrochloride and nitrobenzene

EC Number:

309-912-6

EC Name:

Benzenamine, reaction products with aniline hydrochloride and nitrobenzene

Cas Number:

101357-15-7

Molecular formula:

This is a UVCB substance. See section 1.2 for individual components.

IUPAC Name:

Benzenamine, reaction products with aniline hydrochloride and nitrobenzene

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.36 - 2.57 kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum throughout study
- Water: ad libitum throughout study
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20°C
- Humidity (%): 55 - 61%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): continuous 12 hours light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g, moistened with 0.5 ml distilled water

Duration of treatment / exposure:

4h

Observation period:

1h, 24 h, 48 h and 72 h post treatment

Number of animals:

2 male, 1 female

Details on study design:

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

TEST SITE
A quantity of 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
The gauze patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). The trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water followed by diethyl ether 4 h after the start of exposure.

SCORING SYSTEM: Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics":

EVALUATION OF SKIN REACTIONS

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4

Oedema formation:

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

Primary irritation index: 0.0; erythema and oedema score: 0.0 for all animals at all time points.
No adverse dermal reactions were noted during the study.

Other effects:

Black-coloured staining was noted at the treatment site of all animals at the 1-hour observation and in two animals at the 24, 48 and 72-hour
observations.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria.

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material did not produce positive criteria in any rabbit according to the EEC labelling regulations and was classified as NONIRRITANT to rabbit skin. No symbol and risk phrase are therefore required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals 0980 No. 404 "Acute Dermal Irritation/Corrosion".

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no adverse dermal reactions.

The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.