Registration Dossier
Registration Dossier
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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
Endpoint summary
Administrative data
Description of key information
One short-term terrestrial toxicity testing (OECD 207) is available on TBzTD:
14d-LC50earthworms > 1049 mg/kg dw.
Additional information
One short-term terrestrial toxicity testing (OECD 207) is available on TBzTD: 14d-LC50earthworms > 1049 mg/kg dw.
According to ECHA's guidance chapter R.7c on information requirements and chemical safety assessment (v4.0, June 201 pp. 158-159) the soil hazard category 3 applies to TBzTD. Classification in this category involves performing a confirmatory long-term toxicity test.
However, terrestrial data are rarely available (less than that required to derive a definitive PNEC for soil organisms). The ECHA's guidance R.7c take into account this issue by describing the circumstances where data-sets of differing quality and completeness can be considered ‘fit for the purpose’ of calculating a PNEC for the chemical safety assessment.
3 cases are described:
- where no soil toxicity data are available
- where acute or short-term soil organism toxicity data is/are available
- where chronic or long-term soil organism toxicity data is/are available
In the dossier of TBzTD one short-term toxicity data is available. In the section "acute or short-term soil organism toxicity data" (p. 149) it is indicated that ""where less than a full soil toxicity data-set is available, both the available soil data and the EPM modified aquatic toxicity data should be used in deriving the PNECsoil. In such circumstances, where the subsequent PEC:PNEC <1, this would constitute an adequate data-set and no further testing would be required."
This testing strategy is in agreement with the information laid on p. 150 "Where long-term toxicity data are not available, all the other data available should be examined to determine whether the data needs of the chemical safety assessment are met. The adequacy and relevance of these data are described above. Only where the data on aquatic effects, and/or short-term toxicity are insufficient to complete the chemical safety assessment, i.e. risks have been identified based on these screening data, new long-term testing need to be conducted."
Currently, the aquatic data-set does not allow the application of the equilibrium partitioning method due to the lack of observed toxic effects. The registrant proposes to perform as a first step an OECD 210 chronic fish toxicity testing (testing proposal) to conclude on the aquatic risk assessment. Depending on the result, the registrant will propose to perform a long-term terrestrial toxicity test on earthworm (preferred test in the absence of clear indication of selective toxicity) in a second step if needed (no toxic effect observed in the chronic fish testing or chronic effects leading to RCR > 1).
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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