Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short term toxicity to fish (goldorfe):

LC50 (96 h) = 68 mg/l

Short-term toxicity to aquatic invertebrates (daphnia magna):

EC50 (48h) > 100 mg/l or solubility limit

Toxicity to aquatic plants (lemna minor):

EC50 (7d) > 63.9 mg/l, equal to nominal concentration of 100 mg/l

Additional information

No experimental data was available on Acid Green 104, except for a brief description of a 96 -hour study on goldorfe (Leuciscus idus L.), reporting a LC50 of 68 mg/l. Due to the lack of details, such result was only taken as a qualitative indication and a read across approach was adopted to complete the assessment. Details on the read across are attached in section 13.

A confirmation to the validity of the read across derives from the similar physicochemical profile of all substances. Target substance and read across substances are soluble in water. In particular at 20 °C, Acid Green 104 has a solubility of 5.5 g/l, Similar Substance 01 of 4.8 g/l and Similar Substance 02 of 53.7 g/l.

As for partition coefficents at 20 °C, all substances show negative value, thus indicating a higher affinity towards the water phase than the organic phase. In particular, Acid Green 104 has a logKow of -1.9, Similar Substance 01 of -1.2 and Similar Substance 02 of -0.7.

Low reliability data on toxicity to fish exposed to Similar Substance 02 was available. Among tested species, Salmo trout resulted as the most sensitive, with a LC50 (48 -96 h) between 10 and 100 mg/l.

Studies on acute toxicity (48 h) to aquatic invertebrates were available for both Similar Substance 01 and 02. In the first case, NOECs were identified at the solubility limit, i.e. 52.9 mg/l in test medium; in the second case, an EC50 (48h) > 100 mg/l was found.

Based on available data of toxicity to aquatic plants exposed to Similar Substance 01, 50 % effects levels on growth rate of frond number or dry weight were above the highest tested concentration of 63.9 mg/l, i.e. 100 mg/l nominal.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), a substance shall be classified as category acute 1 (H400) when:

96 hr LC50 (for fish) < 1 mg/l and/or

48 hr EC50 (for crustacea) < 1 mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants) < 1 mg/l.

 

Moreover, if adequate chronic toxicity data is not available, a substance shall be classified as category chronic 3 (H412) when:

96 hr LC50 (for fish): 10 - 100 mg/l and/or

48 hr EC50 (for crustacea): 10 - 100 mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants): 10 - 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log Kow ≥ 4).

The decision on classification was derived from available experimental data on Acid Green 104 as well as on read across substances. A classification in category 3 for aquatic chronic toxicity (H412) was based on results obtained in the short-term toxicity study on fish, i.e. LC50 (48 - 96 h) between 10 - 100 mg/l.