Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Aquatic Chronic 3 (H412), according to the CLP Regulation (EC) No 1272/2008.

Additional information

Adequate chronic toxicity data are not available for Direct Black 168, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on both Direct Black 168 sodium and lithium salts. The use of information on the analogous can be considered as suitable and appropriated because the difference is expected to not influence the ecotoxicological properties. The impurity profile does not impact on the read across proposed. Details on the approach followed are included in the document attached to the IUCLID section 13.

 

Direct Black 168 has a log Kow lower than 4, indicating a low potential for bioaccumulation and it is not rapidly degradable.

 

According to the CLP Regulation (EC) No 1272/2008, acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacean species 48-hour EC50 and/or an algal species 72- or 96-hour EC50; these species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms.

 

Data are available for fish (Brachydanio rerio), Daphnia magna and algae (Desmodesmus subspicatus and Pseudokirchneriella subcapitata).

The outcomes of the tests performed on the three trophic levels suggest that algae is the most sensitive species, thus the classification should be based on the related data. According to the CLP Regulation (EC) No 1272/2008 criteria for the identification of the classification categories for hazardous to the aquatic environment, studies about short-term toxicity to invertebrates and toxicity to aquatic algae fixed the short-term effect level in the range of 10 -100 mg/l.

 

In conclusion, the Direct Black 168 is classified as Aquatic Chronic 3 (H412), according to the CLP Regulation (EC) No 1272/2008.