1,4-bis(p-tolylamino)anthraquinone

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:

guideline study

Justification for type of information:

Data is from experimental report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Skin irritation study of test chemical was conducted on New Zealand White rabbits under occlusive condition according to OECD guideline 404.

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(p-tolylamino)anthraquinone

EC Number:

204-909-5

EC Name:

1,4-bis(p-tolylamino)anthraquinone

Cas Number:

128-80-3

Molecular formula:

C28H22N2O2

IUPAC Name:

1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone

Test material form:

solid

Details on test material:

- Name of test material (IUPAC name): 1,4-Bis(p-tolylamino)anthraquinone
- Common name: C.I. Solvent Green 3
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Smiles notation: c12c(c(Nc3ccc(cc3)C)ccc1Nc1ccc(cc1)C)C(=O)c1c(C2=O)cccc1
- InChl: 1S/C28H22N2O2/c1-17-7-11-19(12-8-17)29-23-15-16-24(30-20-13-9-18(2)10-14-20)26-25(23)27(31)21-5-3-4-6-22(21)28(26)32/h3-16,29-30H,1-2H3
- Substance type: Organic
- Physical State: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KLEENTIERFARM MADOERIN AG; 4414 FUELLINSDORF; SWITZERLAND
- Age at study initiation: 12 -16 weeks
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: The animals were caged individually in stainless steel cages.
- Diet (e.g. ad libitum): Standard kliba rabbit maintenance food;ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degC
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours/day

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Polyethylene glycol / Saline (70/30 PARTS)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration : 50%

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 70% polyethylene glycol + 30 % saline

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 (2 males and 1 female)

Details on study design:

TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): Observed at 1, 24, 48 and 72 hours.

SCORING SYSTEM:
- Method of calculation: Draize method.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test chemical showed no irritation,when applied to intact rabbit skin.

No destructions or irreversible alterations of the treated skin were observed. Thus it was concluded that no corrosion effect had occured on the skin.

Other effects:

In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period.
No destructions or irreversible alterations of the treated skin and no corrosion effects had occurred on the skin.
Also the mean primary irritation index was estimated to be 0.0.
Thus on basis of scores and observed effects, the test chemical was considered to be not irritating to the rabbits’ skin under tested experimental condition.

Executive summary:

Skin irritation study was conducted on New Zealand White rabbits under occlusive condition to assess the irritation potential of the test chemical. The study was performed according to OECD guideline 404. 

The test chemical was applied to the intact skin of three rabbits (2 male and 1 female) for exposure period of 4 hours under occlusive condition at a dose of 50% in Polyethylene glycol / Saline (70/30 Parts). The skin reactions were recorded at 1, 24, 48 and 72 hours according to Draize method.

In the area of application a moderate to slight greyish discoloration of the skin was observed. This effect was recorded in the rabbits during the entire observation period.

No destructions or irreversible alterations of the treated skin and no corrosion effects had occurred on the skin.

Also the mean primary irritation index was estimated to be 0.0.

Thus on basis of scores and observed effects, the test chemical was considered to be not irritating to the rabbits skin under tested experimental condition.