1,1'-(methylenedi-4,1-phenylene)bis(3-butylurea)

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

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 fish 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 fish is scientifically unjustified. Note that the acute toxicity test with Brachydanio rerio revealed LC50 (96 h) of greater than 250 mg/L (nominal concentration).
Moreover, all available data indicate that aquatic toxicity is unlikely to occur, being in accordance with Annex VIII Section 9.1.3. Column 2. Consequently, adequate information for environmental classification and labeling is available or will be addressed by BMF study currently being conducted. 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 attached to IUCLID section 13).

Description of key information

The performance of a test for long-term toxicity to fish is scientifically unjustified.

Additional information

The performance of a test for long-term toxicity to fish 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 fish is scientifically unjustified.  Note that the acute toxicity test with Brachydanio rerio revealed LC50 (96 h) of greater than 250 mg/L (nominal concentration).

Moreover, all available data indicate that aquatic toxicity is unlikely to occur, being in accordance with Annex VIII Section 9.1.3. Column 2. Consequently, adequate information for environmental classification and labeling is available or will be addressed by BMF study currently being conducted. 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 attached to IUCLID section 13).