Registration Dossier
Registration Dossier
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EC number: 201-302-7 | CAS number: 80-70-6
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
With high probability acutely not harmful to fish
Key value for chemical safety assessment
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore, according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of <insert substance> (Q)SAR results were used for toxicity to aquatic organisms. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Therefore, and for reasons of animal welfare further experimental studies on aquatic toxicity are not provided.
Assessment
Due to the abscence of experimental data, the assessment of the acute toxicity of 1,1,3,3 -Tetramethylguanidine (CAS 80 -70 -6) to fish is based on the estimations of two valid QSAR models: OECD (Q)SAR Toolbox v4.1 and EPI Suite v4.11 ECOSAR 96-h fathead minnow LC50 v1.11.
According to the prediction of these estimations the 96-h LC50 value was > 100 mg/L. (OECD (Q)SAR Toolbox v4.1: 1050 mg/L; EPI Suite v4.11 ECOSAR 96-h fathead minnow LC50 v1.11: 957 mg/L). The substance was within the applicability domain of the models.
Based on available calculated data from the weight-of-evidence 1,1,3,3 -Tetramethylguanidine (CAS 80 -70 -6) is considered to be with high probability acutely not harmful to fish.
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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