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EC number: 297-025-4
CAS number: 93281-13-1
Aquatic Chronic 3 (H412), according
to the CLP Regulation (EC) No 1272/2008.
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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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