2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

The skin irritation of test chemical was determined on intact skin of rabbits under occlusive condition.

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(p-tolylamino)anthraquinone

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

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 m+ 1 f)

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:

1,4-bis(p-tolylamino)anthraquinone 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

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of this experiment the test material caused no irritation when applied to intact rabbit skin.

Executive summary:

Under the conditions of this experiment the test material was observe to cause no irritation when applied to intact rabbit skin. 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 observa tion period. No corrosion effect had occured on the skin. The calculated Mean irritation index for intact skin was observed to be 0. Thus on the basis of the study and by comparing CLP criteria for classification of the substance, the test material is not considered to be a skin irritant.