Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)

Endpoint summary

Description of key information

Skin irritation (Draize Test, 72 h): Under the test conditions chosen the test substance does not give indication of an irritant property to the skin (Stahl SE, 1980).

Eye irritation (Draize Test, 72 h): Under the test conditions chosen the test substance is not irritant to the eye

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

other: experimental data on similiar substance

Adequacy of study:

key study

Study period:

1979-10-22 to 1980-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, § 1500.41 (Draize test)

Version / remarks:

1973

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weight: males 3.16 kg, female 3.46 kg
The animals were offered a standardized animal laboratory diet.

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

water

Controls:

other: untreated skin of the animals

Amount / concentration applied:

about 0.5 g of a 50 % aqueous test substance preparation

Duration of treatment / exposure:

24 hours

Observation period:

8 days

Number of animals:

6 (5 males, 1 female)

Details on study design:

Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h / 72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h / 72 h

Score:

0.75

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: abraded skin

Irritant / corrosive response data:

Due to substance-coloured skin, determination of the erythema score was not possible.

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

Not irritant to skin

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:

other: read across from analogue substance

Adequacy of study:

key study

Study period:

1979-10-01 to 1980-03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, § 1500.42 (Draize test)

Version / remarks:

1973

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Mean body weight: male 3.02 kg, females 2.84 kg
The animals were offered a standardized animal laboratory diet.

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

62 mg (= 0.1 mL bulk volume)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6

Details on study design:

The test substance was not washed out.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 d

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 d

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 d

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tsetd for eye irritation following Fed. Reg. 38, No. 187, § 1500.42 (Draize test). Under the experimental conditions the substance is not eye irritant/corrosive.

Executive summary:

Following the experimental design according to Federal Register 38, No. 187 § 1500.42, 1973, 0.1 mL of the test substance was instilled in the conjunctival sac of six Vienna White rabbits. The eyes were not washed after 24 hours of exposure. Animals were observed for 8 days. Irritation was scored by the method of Draize et al..

The application to the intact eye resulted in marked redness in all animals after 24 hours. The effect was not fully reversible, after 8 days three of 6 animals showed a slightly redness (grade 1) of the conjunctivae. As the eyes were not washed out and the animals were only observed for 8 days instead of 21 days as recommended in the current OECD 405 guideline, it is reasonable to assume that effects would be less pronounced and fully reversible if the eyes would have been washed out and/or the observation period would have been extended to 21 days. Slight to marked chemosis was observed in all animals, but was fully reversible within 72 hours. After application, all animals showed a slight corneal opacity, which was completely resolved by the end of the study. The iris of two animals was affected by the test item after 24 hours, but this effect was fully reversible within 48 hours.

Based on these observations, the test article is not corrosive nor irritant to the eye of rabbits based on Regulation 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation
Following the experimental design according to Federal Register 38, No. 187, § 1500.41, 1973, 0.5 g of a 50 % solution of the test substance with water was applied to the intact or abraded skin of six Vienna White rabbits. Test sites were covered with an occlusive dressing for 24 hours and the remaining test substance was not washed off.
Due to substance-coloured skin, determination of the erythema score was not possible. The mean edema score for the intact skin was 0 (mean: 24 h, 72 h). Therefore the test substance did not cause any irritation on the intact skin of the test animals. All animals with abraded skin developed very slight edema at 24 h. After 72 hours three of six animals showed a very slight edema. The mean edema score for the abraded skin was 0.75 (mean: 24 h, 72 h). Observed edema effects were fully reversible within 8 days. Because of these findings regarding the intact skin, the test substance is not considered irritating to the skin.

Eye irritation

Following the experimental design according to Federal Register 38, No. 187 § 1500.42, 1973, 0.1 mL of the test substance was instilled in the conjunctival sac of six Vienna White rabbits. The eyes were not washed after 24 hours of exposure. Animals were observed for 8 days. Irritation was scored by the method of Draize et al..

The application to the intact eye resulted in marked redness in all animals after 24 hours. The effect was not fully reversible, after 8 days three of 6 animals showed a slightly redness (grade 1) of the conjunctivae. As the eyes were not washed out and the animals were only observed for 8 days instead of 21 days as recommended in the current OECD 405 guideline, it is reasonable to assume that effects would be less pronounced and fully reversible if the eyes would have been washed out and/or the observation period would have been extended to 21 days. Slight to marked chemosis was observed in all animals, but was fully reversible within 72 hours. After application, all animals showed a slight corneal opacity, which was completely resolved by the end of the study. The iris of two animals was affected by the test item after 24 hours, but this effect was fully reversible within 48 hours.

Based on these observations, the test article is not corrosive nor irritant to the eye of rabbits based on Regulation 1272/2008

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The substance is not classified as skin irritant nor eye irritant under Regulation 1272/2008