[1,1'-Bianthracene]-9,9',10,10'-tetrone, 4,4'-bis[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1991 to January 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented OECD guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

not relevant

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

308 AQN

IUPAC Name:

308 AQN

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

At the start of the study the animals weighed 2.44 - 2.59 kg and were twelve to sixteen weeks old. After a minimum acclimatiation period of five days each animal was given a number unique within the study which was written with black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individally housed in suspended metal cages. Free access to mains drinking water and food (Spiller Rabbit Diet, Degety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
The animal room was maintained at a temperatire of 17 - 21 °C and relative humidity of 35 - 55 %. The rate of air exchange was approximately 15 charges per hour and the lighting was controlled by a time switch to give continuous 12 hours light and 12 hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

A quantity of 0.5 g of the test material, moistered with 0.6 ml of distilled water, was introduced under a 2.5 cm * 2.5 cm gauze patch and placed in position on the shorn skin.

Duration of treatment / exposure:

4 hours.

Observation period:

1 hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined.

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm * 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with distilled water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: Primary irritation index

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: After 72 hour observation

Score:

2.3

Max. score:

2

Irritant / corrosive response data:

Very slight to well-defined erythema was noted at all treated skin sites at the 48-hour observation. Very slight erythema was noted at two treated skin sites at the 72-hour observation.
Very slight oedeme was noted at one treated skin site one hour after patch removal. Slight oedema was noted at two treated skin sites at the 24-hour observation with very slight to slight oedema at the 48 and 72-hour observations.

Other effects:

Desquamation was confined to two treated skin sites seven days after treatment.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test material, No. 308 AQN, produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material produced possitive criteria in 1/3 rabbits according to the ECC labelling regulations and was classified as non-irritant to rabbit skin. No symbol and risk phrase are therefore required.

Executive summary:

The test material, No. 308 AQN, produced a primary irritation index of 2.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The test material produced possitive criteria in 1/3 rabbits according to the ECC labelling regulations and was classified as non-irritant to rabbit skin. No symbol and risk phrase are therefore required.