Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Not harmful/toxic for aquatic life.

Additional information

Adequate chronic toxicity data is not available for Direct Orange 118, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on the substance and on structural analogues.

Direct Orange 118 is not rapidly degradable; however, based on the log Kow value, the substance is expected to possess a low potential for bioaccumulation.

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; 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.

The mentioned species cover a range of trophic levels and taxa and are considered as surrogate for all aquatic organisms. Data on Direct Orange 118 and analogues are available for fish (Poecilia reticulata), invertebrates (Daphnia magna) and aquatic plants (Lemna gibba).

No L(E)C50 value was recorded at concentration equal/lower than 1 mg/l, thus the classification criteria for acute (short-term) aquatic hazard (category 1) of the CLP Regulation (EC) No 1272/2008 are not met.

In addition, no acute toxicity (i.e. L(E)C50) was recorded in none of the experiments conducted, up to 100 mg/l; thus the classification criteria for long-term aquatic hazard (categories 2/3/4) of the CLP Regulation (EC) No 1272/2008 are not met.

In conclusion, the outcomes of the tests performed on the three trophic levels suggest that Direct Orange 118 is not harmful/toxic for aquatic life.