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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

yes

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

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)

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

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.

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.

                              

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

The observation period has not been specified.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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
- Water (e.g. ad libitum): tap water

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approx. 100mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours, 7, 14, and 21 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

Slight Harderian discharge was observed in 1 animal on day 1 only.

Interpretation of results:

GHS criteria not met

Conclusions:

Testing of the test item for primary eye irritation in the rabbit showed that the substance is not irritating to eyes. The substance is not classifiable according to CLP criteria.

Executive summary:

In a primary eye irritation study equivalent or similar to OECD 405 of the test item was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits for 24 hours. Animals then were observed for 21 days/until reversibility has seen. Irritation was scored by the method of Draize.

All animals showed a slight redness of the conjunctivae. The mean score over 24, 48, and 72 h was 0.3 each for two rabbits and 0.7 for the third animal. Additionally the third rabbit showed a chemosis mean score of 0.3. No other signs of irritation have been observed.

In this study, the test item is not an eye irritant based on CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results in the in vivo tests OECD 404 and 405 with rabbits, the test item is not classifiable according to CLP criteria. No relevant irritation effect was observed, neither on skin nor in eyes.