N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide

Endpoint summary

Description of key information

The test substance is not irritating to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

HC:NZW Albino Rabbits
Source: : Interfauna UK Ltd
Food: ssniff K 4
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: 3.1 to 3.3 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: approx. 50 %
- Lighting time: 12 hours daily

In-life date: 18. Oct to 25. Oct. 1988

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg on 6x6 cm2 plaster

Duration of treatment / exposure:

4 hours

Observation period:

up to 7 d

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 and shaved over an area of 6 cm x 6 cm
- Area of exposure: shaved skin 6 cm2
- Type of wrap if used: Fixomull-Stretch as elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to the score of Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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 systemic toxicity were observed during the observation period

Interpretation of results:

GHS criteria not met

Conclusions:

In the experimental conditions described by OECD guideline 404 for evaluation of the acute dermal irritation / corrosivity of the substance Disperse Violet 93:1 is detemined to be not irritating to the skin.

Executive summary:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 36 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g Disperse Violet 93:1 pasted with water. The substance was applied over the whole surface of a 6x6 cm² plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with water.

Examinations of the skin took place after 60 minutes as well as 24, 48 and 72 hours and 7 days after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

No signs of irritation occurred during the whole study.

Testing of Disperse Violet 93:1 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Jan. 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: mean 2.2 kg
Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

up to 8 days

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 clipper over an area of 8 cm x 8 cm
- Area of exposure: 2.5 x 2.5 cm, covered with gauze
- Type of wrap if used: gauze, fixed with plaster (Leukoflex) covered with cellulose and fixed with an elastic bandage (Eloflex) (semi-occlusive)


REMOVAL OF TEST SUBSTANCE
- Washing: with water or olive oil
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to the score of Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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 systemic toxicity were observed during the observation period

Interpretation of results:

GHS criteria not met

Conclusions:

In the experimental conditions described by OECD guideline 404 for evaluation of the acute dermal irritation / corrosivity of the substance Disperse Violet 93:1 is detemined to be not irritating to the skin.

Executive summary:

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 64 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g Disperse Violet 93:1 pasted with water. The substance was applied on the skin and covered with 2.5 x 2.5 cm² of medical gauze. The gauze was then covered with a semi-occlusive bandage.

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with water or olive oil.

No signs of skin irritation was observed at any observation point. hence, Disperse Violet 93:1 is not irritating to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

18. Oct. to 25. Oct. 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

HC:NZW Albino Rabbits
Source: : Interfauna UK Ltd
Food: ssniff K 4
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: 2.3 to 3.4 kg

In-life date: 18. Oct to 25. Oct. 1988

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µL (approx. 10 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours and 7 days after application of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes with isotonic saline
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein; at 24 hours the eyes were also examined for corneal lesion under UV light and white light after instillation of one drop of 1% fluorescein solution. Cornea, Iris, aqueous humor by means of a hand-slit lamp

SCORING SYSTEM: according to OECD guideline 405

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight reddening and lachrimation (both Score 1) was observed in all animals at the 1 hour observation point. No adverse effects were seen thereafter.

Interpretation of results:

GHS criteria not met

Conclusions:

Testing of Disperse Violet 93:1 for primary eye irritation in the rabbit showed, that the substance is not irritating to eyes.

Executive summary:

100 µL (10 mg) of Disperse Violet 93:1was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

24 hours after application the treated eyes were washed out thoroughly with isotonic saline.

The eyes were examined 1, 24, 48 and 72 hours and 7 days after application of the test substance.

At 24 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 1 % fluorescein solution. Lesions in cornea. iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

Slight reddening and lachrimation (both Score 1) was observed in all animals at the 1 hour observation point. No adverse effects were seen thereafter.

Hence, Disperse Violet 93:1 is not irritating to eyes.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: mean 2.2 kg
Acclimation: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 µL (ca. 10 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The eyes were examined 1, 24, 48, 72 hours and 8 days after application of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance
- Time after start of exposure: NA

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: ophthalmoscope
fluorescein: at 24 hours the eyes were also examined for corneal lesion under UV light after instillation of one drop of fluorescein solution.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Testing of Disperse Violet 93:1 for primary eye irritation in the rabbit showed, that the substance is not irritating to eyes.

Executive summary:

100 µL of Disperse Violet 93:1was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

The treated eyes were examined 1, 24, 48 and 72 hours and 8 days after application of the test substance.

At 24 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of a fluorescein-solution.

According to the study performed, Disperse Violet 93:1 is not irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

For skin irritation testing, each animal was treated with 0.5 g Disperse Violet 93:1 pasted with water.

Examinations of the skin took place after 60 minutes as well as 24, 48 and 72 hours and 7/8 days after removal of the patches.

Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.

No signs of irritation occurred during the whole study.

Testing of Disperse Violet 93:1 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.

100 µL (ca. 10 mg) Disperse Violet 93:1was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

The eyes were examined 1, 24, 48 and 72 hours and 7/8 days after application of the test substance.

At 24 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of a fluorescein solution. Lesions in cornea. iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded.

Based on the individual scores after 24, 48 and 72 hours, no signs of irritation were noted

Testing of Disperse Violet 93:1 for primary eye irritation in the rabbit showed, that the substance is not irritating to the eye.