Reaction mass of methyl acetate and methanol

Long-term toxicity to aquatic invertebrates

Description of key information

In compliance with section 1 of Annex XI to Regulation (EC) 1907/2006 (REACH) the study on long-term toxicity to aquatic invertebrates was waived because the chemical safety assessment of the registration substance did not reveal the need to investigate further effects on fish. However, based on a read-across approach to the structural analogue Methanol (CAS 67 -56 -1) a NOEC of >100 mg/L was derived.

Additional information

According to section 1 of Annex XI to Regulation (EC) 1907/2006 (REACH) testing of long-term toxicity to aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further effects. The registration substance is neither classified for environmental hazards according to Regulation (EC) 1272/2008 (CLP), nor is it identified as PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. This conclusion is supported by assessments for the structural analogues Methanol (CAS 67-56-1) and Methyl acetate (CAS 79-20-9) provided in its public ECHA REACH dossiers demonstrating that long-term toxicity to fish is not to be expected. Therefore, generating additional data is scientifically not justified.

 

Nevertheless, supporting information available for the structural analogue Methanol is presented below.

 

Supporting information

Methanol

Results from fully reliable studies on chronic toxicity of methanol to aquatic invertebrates are not available.

In a semi-static young Daphnia magna (< 24 hours old, 10 animals per treatment) were exposed to nominal test item concentrations of 1219, 4385, 8771, 12190 and 19260 mg/L. The temperature and light was maintained at 20 ± 1 °C with a photoperiod of 14 h light/10 h dark throughout the study. The 21-day NOEC (reproduction) and 21-day NOEC (growth) were determined to be 122 g/L and 4380 mg/L, respectively (Dom et al., 2012).

Roex et al. (2000) and Raimondo et al. (2007) investigated the variability in acute-to-chronic ratios (ACRs) based on an extensive data set on acute aquatic toxicity of various chemicals. As a result, Roex et al. (2000) derived an average ACR for nonpolar narcotics of 2.58 +/- 1.57. According to Raimondo et al. (2007) the median ACR for chemicals classified as nonpolar narcotics is 9.9, which is in the same order of magnitude as the ACR determined by Roex et al. (2000).

Conclusion

In compliance with section 1 of Annex XI to Regulation (EC) 1907/2006 (REACH) the study on long-term toxicity to fish was waived because the chemical safety assessment of the registration substance did not reveal the need to investigate further effects on fish. However, supporting information on long-term toxicity of the source substance methanol were taken into account. The results of a 21 d study on the toxicity of methanol on Daphnia magna are reported in a publication of Dom et al. (2012). The study reports a NOEC of 122 mg/L for reproduction of Daphnis magna. Additionally, several short-term toxicity studies are available for aquatic invertebrates, all consistently demonstrating a very low acute toxicity of methanol. Since methanol exerts toxicity with a non-specific mode of action (narcotic toxicity), the chronic toxicity to Daphnia magna can be reasonably extrapolated from acute data using an acute to-chronic ratio of 10 (Raimondo et al., 2007; Roex at al., 2000). A chronic toxicity of >100 mg/L is thus to be expected for the source substance Methanol. By applying a read across approach NOEC of the target substance for long-term toxicity to aquatic invertebrates is considered to be >100 mg/L.