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Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The performance of a test for long-term toxicity to aquatic invertebrates (Daphnia sp.) is scientifically unjustified.
REACh Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1 Col. 2, states as follows:
“9.1: Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.”

The water solubility of HAT-ISO was determined to be 0.0497 mg/L at 20 °C and the substance is considered highly insoluble in water. Therefore, performance of a test for long-term toxicity to aquatic invertebrates is scientifically unjustified. Note that HAT ISO was tested for acute toxicity to Daphnia magna in a 48 h static test, with immobilisations observed were not proportional to the test concentration. Thus, the 48 h EC50 for Daphnia magna was shown to be higher than the limit of solubility.
Moreover, all available data indicate that aquatic toxicity is unlikely to occur, being in accordance with Annex VII Section 9.1.1. Column 2. Consequently, more than adequate information for environmental classification and labeling is available or will be addressed as soon as results of the currently running BMF study are available. Therefore, and referring to Annex IX Section 9.1. Column 2, long-term toxicity testing is considered to not be scientifically justified, as the CSA according to Annex I does not indicate the need to investigate further the effects on aquatic organisms. All uses of the substance were considered to be adequately controlled and judged to be safe (please refer to the CSR).

Description of key information

The performance of a test for long-term toxicity to aquatic invertebrates (Daphnia sp.) is scientifically unjustified.

Key value for chemical safety assessment

Additional information

The performance of a test for long-term toxicity to aquatic invertebrates (Daphnia sp.) is scientifically unjustified.

REACh Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1 Col. 2, states as follows:

“9.1: Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.”

The water solubility of HAT-ISO was determined to be 0.0497 mg/L at 20 °C and the substance is considered highly insoluble in water. Therefore, performance of a test for long-term toxicity to aquatic invertebrates is scientifically unjustified.  Note that HAT ISO was tested for acute toxicity to Daphnia magna in a 48 h static test, with immobilisations observed were not proportional to the test concentration. Thus, the 48 h EC50 for Daphnia magna was shown to be higher than the limit of solubility.

Moreover, all available data indicate that aquatic toxicity is unlikely to occur, being in accordance with Annex VII Section 9.1.1. Column 2. Consequently, more than adequate information for environmental classification and labeling is available or will be addressed as soon as results of the currently running BMF study are available. Therefore, and referring to Annex IX Section 9.1. Column 2, long-term toxicity testing is considered to not be scientifically justified, as the CSA according to Annex I does not indicate the need to investigate further the effects on aquatic organisms. All uses of the substance were considered to be adequately controlled and judged to be safe (please refer to the CSR).