Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Sensitisation was assessed using the Buehler sensitisation assay. During the induction phase, the test sample stained the application sites and prevented a visual assessment of erythema.  Signs of slight irritation were observed in two animals.  Following challenge with a 75% w/v preparation, the application sites of all animals were stained by the test sample.  This staining prevented assessment of the responses in 1 test animal.  No erythematous responses were observed in any of the remaining test or control animals.

 

 Following challenge with a 30% w/v preparation, the application sites of 5 test and 5 control animals were stained by the test sample. However, this staining did not prevent the assessment of the responses. No erythematous responses were observed in any of the test or control animals. 

 

Following challenge with a 10% w/v preparation, the application sites of 9 test and 3 control animals were stained by the test sample.  This staining prevented assessment of the responses in 2 test animals.  No erythematous responses were observed in any of the remaining test or control animals.

 

Following challenge with a 3% w/v preparation, the application sites of 17 test and 3 control animals were stained by the test sample.  This staining prevented assessment of the responses in 5 test animals and 2 control animals.  No erythematous responses were observed in any of the remaining test or control animals.

 

On the basis of the results, the substance cannot be considered to be a skin sensitiser.

Migrated from Short description of key information:
Summary of skin sensitization data

Respiratory sensitisation

Endpoint conclusion

Additional information:

The registered chemical is a reactive dye. For this class of dyes it was generally agreed between the members of theEcological and Toxicological Association of Dyes and Organic Pigments Manufacturers (ETAD) that a possible risk for respiratory sensitisation for workers exists at high exposure. However the following should be noted:

 

1) For the substance no history of respiratory problems, such as occupational asthma, is associated with the manufacture and use of the specific substance.

 

2) Due to the granular form of the substance (spay dried in closed system from aqueous solution directly after synthesis) no risk for inhalative exposure arises.

 

The potential to cause respiratory sensitisation is therefore not considered to be applicable for this substance.

No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Migrated from Short description of key information:
Not assessed. No evidence of respiratory sensitisation was noted in any of the studies conducted, and it is proposed that the substance is not a respiratory sensitiser.

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for sensitisation effects is therefore required.

Categories Display