2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

EC Number:

216-251-6

EC Name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Cas Number:

1533-78-4

Molecular formula:

C22H24ClN5O7

IUPAC Name:

2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate

Test material form:

solid

Details on test material:

Disperse Red 167:1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater, Manchester, UK
-Age at study initiation: between 11 and 17 weeks
- Weight at study initiation: 2.14-2.71Kg
- Housing: individually in satinised aluminium sheet cages
- Diet: Labsure CR6 Rabbit Diet ad libidum
- Water: via an automatic system ad libidum

ENVIRONMENTAL CONDITIONS
- Temperature: 16-20°C
- Humidity: 43-80 %
- Photoperiod: 12 hours cycle dark/lights maintained at a temperature

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g, pasted with 0.4 mL of deionised water

Duration of treatment / exposure:

4 hours

Observation period:

examination after 30-60 minutes, 1, 2 and 3 days after removal

Number of animals:

3

Details on study design:

TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped. Only animals with intact skin were used.
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze, covered by a piece of impermeable rubber sheeting, secured with adhesive impermeable polyethylene tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with warm tap water
- Time after start of exposure: after 4 hours

SCORING SYSTEM: according to the score of Draize (see table 1 in "Any other information on materials and methods incl. tables)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Time point:

24/48/72 h

Remarks on result:

not determinable

Remarks:

Erythema could not be assessed as the skin was stained red by the test material

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

At the end of the study the application sites were submitted for histopathological examination which revealed no obvious evidence of an inflammatory reaction. On the basis of the histopathological findings and the lack of oedematous reaction the test material is considered unlikely to be an irritant to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions described for evaluation of the acute dermal irritation / corrosivity, the test item is detemined to be not irritating to the skin.

Executive summary:

In a dermal irritation study equivalent to OECD 404 with the test item, 3 young adult New Zealand White rabbits were dermally exposed to 0.5 g test item in water for 4 hours to approx. 6.25 square centimetres body surface area. Animals then were observed for 3 days. Irritation was scored by the method of Draize.

No signs of oedema were observed throughout the study. Erythema could not be assessed as the test item stained the skin red. At the end of the study the application sites were histopathological examined. There was no evidence of an occurred inflammation.

Based on these results, the test item is considered to be non-irritant according to CLP criteria.