[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers

Endpoint summary

Description of key information

The irritating behaviour of the substance has been determined by read-across from a structural analogue in adequate studies in the rat and rabbits by application of the substance into the skin and into the eye. No studies are available for respiratory irritation.

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:

See report in section 13 "Other reports"

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION: The skin irritation potential of the substance with CAS 218502-12-4 (Direct Black 168 Na Li salts) has been evaluated by read-across from an structural analogue, CAS 93281-13-1 (Direct Black 168 Na salt). The source substance was assessed following three experiments conducted in rabbits, two of them according to the OECD Guideline 404. In two of the experiments, the result of the assessment resulted in mean scores for erythema and edema, 24 , 48 and 72 hours after treatment of 0.00 for the treated animals. The third experiment identified a different skin irritation potential. Based on the available information, an explanation was not clearly evident. The substance had an intense colour, thus readings in irritation tests were difficult, due to substance staining. A fourth piece of information from a similar Substance 01 was taken into consideration to conclude that the source substance was not skin irritant.

Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file.

EYE IRRITATION: The eye irritation potential of the substance with CAS 218502-12-4 (Direct Black 168 Na Li salts) has been evaluated by read-across from an structural analogue, CAS 93281-13-1 (Direct Black 168 Na salt). The source substance was assessed by means of three experiments conducted in rabbits according to the OECD Guideline 405. There were some differences between the conclusion reached in the first study (Ullman, 1990) respect those in the other two experiments (Genoher, 2000 and Tortajada, 1993), that were attributed to a different approach about how to consider the staining. In the first experiment, although black staining of the cornea, iris, conjunctivae, nictitating membrane, sclera and of the eyelashes by the test material was noted in all animals until termination of observation (i.e. 72 hours), it was concluded that the substance was not irritating.

Based on the results from the other two experiments, the substance seemed to be able to cause eye irritation. All the effects on the cornea, iris or conjunctiva resulted to be fully recovered within the 21st day; only staining of the nictitante membrane persisted until the reading at 21st day. However, considering that humans have only a rudimentary nictitante membrane, a classification as Eye Irrit 2 (H319) seemed to be appropriate for the source substance.

Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file.

 

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, the substance does not meet the criteria to be classified for the skin irritation.

According to the CLP Regulation (EC) No 1272/2008, the substance should be classified as Eye Irritant, Category 2 (H319)