2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

EC Number:

226-070-4

EC Name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

Cas Number:

5261-31-4

Molecular formula:

C19H17Cl2N5O4

IUPAC Name:

2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Body weight: 2.7 - 2.8 kg
Room temperature and relative humidity: 19-25°C and 40-60%, respectively
Light period: 12 h light/12 h dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.5 g of test substance paste

Duration of treatment / exposure:

4 h, after which the test sites were washed

Observation period:

72 h; the skin was checked for irritation (erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h

Number of animals:

3

Details on study design:

Approximately 24 h before the test, the fur was shaved from the dorso-lateral area of the trunk (6 cm x 6 cm). 500 mg of the pulverized test substance were moistened with water and subsequently applied to a hypoallergenic patch (2.5 x 2.5 cm). Patches were held in place with semi-occlusive dressing for 4 h.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of erythema, eschar and oedema or ulcerations, necrosis, and scarring were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance according to OECD Guideline 404 and EU Method B.4. Female New Zealand White rabbits were exposed for 4 h to 0.5 g of the test substance (paste with water). The test site was shaved and the type of coverage applied was semi-occlusive. After 4 h, the skin was washed with water. The skin sites were checked for irritation (Draize scores - erythema, eschar, oedema) and corrosion (ulcerations, necrosis, scarring) after 24, 48 and 72 h. No signs of skin irritation or corrosion were observed during the study. Under the study conditions, the test substance was not considered to be irritant/corrosive to rabbit skin (Suberg, 1985).