Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione

Endpoint summary

Description of key information

Read across to an analogue substance: Reliable in vivo skin and eye irritation studies using rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: overall at 24.5, 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24.5, 48 and 72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

Based on read across to an in-vivo study for an analogue substance, Solvent Blue 79 is predicted to be non-irritating to the skin. This material would not be classified under EU regulations.

Executive summary:

A read across approach was used to an analogue substance; Solvent Blue 98, which has a similar composition/structure. (Please see read across justification document for more information)

The skin irritation potential of the analogue material was evaluated in New Zealand White rabbits. There were no irritative effects observed in any of the animals at any time-point. All animals appeared normal throughout the course of the study. The individual animal mean scores for the 24.5, 48 and 72 hr time-point for the intact skin indicated that this material would not be classified under EU regulations.

Based on the analogue read across approach, the target substance Solvent Blue 79 is predicted to be non irritating 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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

Based on read across to an in-vivo study for an analogue substance, Solvent Blue 79 is predicted to be non-irritating to the eyes. This material would not be classified under EU regulations.

Executive summary:

A read across approach was used to an analogue substance; Solvent Blue 98, which has a similar composition/structure.

(Please see read across justification document for more information)

The primary ocular irritation potential of the analogue material was evaluated in New Zealand White rabbits. One group of six albino rabbits received a single, unwashed exposure. A 0.1- ml dose of the test article was instilled into the lower conjunctival sac of one eye. The eyelids were held together for approximately one second and released. The other eye served as an untreated control. The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48 and 72 hours after dosing and on study day 7.

Three of six animals were noted with positive cornea opacity effects (maximum score grade 1), iridal effects (maximum score grade 1), conjunctival redness (maximum score grade 2) and conjunctival chemosis (maximum score grade 2). The other three animals showed no effects throughout the study. All positive effects observed had resolved by day 7. The individual animal mean scores for the 24, 48 and 72 hr time-point indicated that this material would not be classified under EU regulations.

Based on the analogue read across approach, the target substance Solvent Blue 79 is predicted to be non irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

A read across approach was used to an analogue substance; Solvent Blue 98, which has a similar composition/structure.

The skin irritation potential of the analogue material was evaluated in New Zealand White rabbits. There were no irritative effects observed in any of the animals at any time-point. All animals appeared normal throughout the course of the study. The individual animal mean scores for the 24.5, 48 and 72 hr time-point for the intact skin indicated that this material would not be classified under EU regulations.

Based on the analogue read across approach, the target substance Solvent Blue 79 is predicted to be non irritating to skin.

A read across approach was used to an analogue substance; Solvent Blue 98, which has a similar composition/structure.

The primary ocular irritation potential of the analogue material was evaluated in New Zealand White rabbits. One group of six albino rabbits received a single, unwashed exposure. A 0.1- ml dose of the test article was instilled into the lower conjunctival sac of one eye. The eyelids were held together for approximately one second and released. The other eye served as an untreated control. The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48 and 72 hours after dosing and on study day 7.

Three of six animals were noted with positive cornea opacity effects (maximum score grade 1), iridal effects (maximum score grade 1), conjunctival redness (maximum score grade 2) and conjunctival chemosis (maximum score grade 2). The other three animals showed no effects throughout the study. All positive effects observed had resolved by day 7. The individual animal mean scores for the 24, 48 and 72 hr time-point indicated that this material would not be classified under EU regulations.

Based on the analogue read across approach, the target substance Solvent Blue 79 is predicted to be non irritating to eyes.

Justification for classification or non-classification

Classification criteria not met.