Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Not harmful/toxic for aquatic life.

Additional information

Adequate chronic toxicity data are not available for Direct Blue 199, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on both Direct Blue 199 and Direct Blue 199, sodium salt. The usage of information on a different salification form, which has the same main component and with a different counter ion, 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 Blue 199 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 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; nevertheless it is also specified in the Regulation that data on other species (e.g. Lemna spp.) shall also be considered if the test methodology is suitable. 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 and Salmo gairdneri), Daphnia magna and Lemna minor.

According to the CLP Regulation (EC 12720/2008) criteria for the identification of the classification categories for hazardous to the aquatic environment, all studies about short-term toxicity to fish and short-term toxicity to aquatic invertebrates fixed the short-term effect level higher than 100 mg/l.

The outcomes of the tests performed on the three trophic levels suggest that Direct Blue 199 is not harmful/toxic for aquatic life.

 

In conclusion, the Direct Blue 199 does not meet the criteria to be classified for the aquatic toxicity, according to the CLP Regulation (EC 1272/2008).