Registration Dossier
Registration Dossier
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EC number: 204-876-7 | CAS number: 128-04-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to further investigate the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
Experimental data for the long-term toxicity of sodium dimethyldithiocarbamate (SDDC, CAS No. 128-04-1) to fish are not available. However, the chemical safety assessment according to Annex I of REACH Regulation (EC) No 1907/2006 does not indicate the need to further investigate the long-term toxicity to fish. Thus, and for reasons of animal welfare, long-term testing on fish is not proposed, in accordance with Annex X, 9.4, column 2.
According to the Guidance on information requirements and chemical safety assessment Chapter R.7b, section R.7.8.5.3 (ECHA, 2017) long-term testing on fish should only be conducted if fish represent the most sensitive taxonomic group. Furthermore, the guidance states that if aquatic invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish.
Experimental data for the short-term aquatic toxicity of SDDC are available for all three trophic levels and provide strong evidence that fish are not the most sensitive taxonomic group. Based on the available short-term aquatic toxicity data, aquatic algae are the most sensitive taxonomic group by a factor of 100 with an ErC50 (72 h) of 0.0012 mg a.i./L relative to aquatic invertebrates with an EC50 (48 h) of 0.68 mg a.i./L and fish with a LC50 (96 h) of 0.76 mg a.i./L.
Experimental data for the long-term aquatic toxicity of SDDC are available for two trophic levels, namely for aquatic algae and invertebrates, as recommended by the guidance document. Based on the available long-term aquatic toxicity data, aquatic algae are the most sensitive taxonomic group by a factor of 10 with an ErC10 (72 h) of 0.00074 mg a.i./L relative to aquatic invertebrates with a NOEC (21 d) of 0.0095 mg a.i./L, thus confirming the same trend observed for the short-term aquatic toxicity of SDDC.
Furthermore, the environmental exposure assessment with PNEC values derived from the available ecotoxicological studies resulted in Risk Characterisation Ratios (RCR) clearly below 1 indicating a low risk to the aquatic ecosystem.
Since both short-term and long-term aquatic toxicity data clearly indicate that aquatic algae are the most sensitive taxonomic group for the aquatic toxicity of SDDC, a long-term test with fish is not expected to significantly deviate from this overall ecotoxicological profile. Therefore, and for reasons of animal welfare, long-term testing on fish is not proposed and the current dataset is considered to be sufficient.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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