Benzenamine, 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(oxy)]bis-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study is in compliance with OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" Adopted 24 April 2002. There was no deviation from the protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test material

Test material information

Constituent 1

Reference substance name:

3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline

EC Number:

700-102-1

Cas Number:

105112-76-3

Molecular formula:

C24H20N2O2

IUPAC Name:

3-{[4'-(3-aminophenoxy)-[1,1'-biphenyl]-4-yl]oxy}aniline

Details on test material:

- Name of test material (as cited in study report): 3,3-(4,4-biphenylenedioxy)dianiline
- Substance type: Raw material for polymer
- Physical state: White powder
- Analytical purity: >99 %
- Lot/batch No.: 20070501
- Expiration date of the lot/batch: End April 2008
- Storage condition of test material: Room temperature
- Other: Date of receipt was 28 August 2007

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited supplier
- Age at study initiation: 34 to 37 weeks
- Weight at study initiation: 4.04 to 4.8 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors at the Eye Research Centre, Eye, Suffolk, England
- Diet (e.g. ad libitum): Each rabbit was offered 125 g of a standard laboratory rabbit diet per day (Rabbit GD Diet Pellets supplied by Highgate Farm)
- Water (e.g. ad libitum): Drinking water was provided ad libitum
- Acclimation period: 16 to 17 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20
- Humidity (%): 40 to 70
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: hair removed with clippers

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

3 minutes, 1 hour (data not reported but archived) and 4 hours

Observation period:

1, 24, 48, 72 hours after removal of the dressings

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 25 mm x 25 mm
- Type of wrap if used: 2-ply porous gauze pad


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water (30 to 40 °C)
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severy erythema (beet redness) or eschar formation (injuries in depth) preventing grading of erythema = 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 (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

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No dermal reaction was observed in any animal throughout the duration of the study.

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 1: Mean values for erythema and oedema 24, 48 and 72 hours after removal of dressings (4 hours of exposure)

Animal number and sex	Erythema		Oedema
	Test	Control	Test	Control
43, female	0.0	0.0	0.0	0.0
50, female	0.0	0.0	0.0	0.0
75, female	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: according to the criteria of the ECETOC

Conclusions:

The Primary Irritation Index (PII) was calculated to be 0.0. 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline was classified as 'non-irritant' according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, "irritating to skin", in accordance with Commission Directive 2001/59/EC.

Executive summary:

A study was performed to assess the skin irritation potential of 3,3-(4,4-biphenylenedioxy)dianiline to the rabbit. The method was described in OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" Adopted 24 April 2002.

Three rabbits received a single semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied for four hours and were observed for four days. No dermal reaction was observed in any animal throughout the duration of the study. The means of scores for these reactions at approximately 24, 48 and 72 hours after administration, calculated separately for each animal, are 0.0 (Erythema) and 0.0 (Oedema) for animal no. 43, 0.0 (Erythema) and 0.0 (Oedema) for animal no. 50 and 0.0 (Erythema) and 0.0 (Oedema) for animal no. 75. The Primary Irritation Index was calculated to be 0.0. Based on these findings the test substance was classified as 'non-irritant' according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, "Irritating to skin", in accordance with Commission Directive 2001/59/EC.