Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

With high probability, acutely not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Additional information

For the assessment of the acute toxicity of 3-(1-ethoxyethyl)-5-methyloxazolidin-2-one (EE-MOX; CAS 123403-95-2) to aquatic invertebrates there are experimental data from a semi-static GLP-guideline study performed according to OECD 202 available, using Daphnia magna as test organism. The 48-h EC50 was determined in this limit test to be >120 mg/L (nominal, analytically verified; not pH adjusted).

In order to support the experimental key data, the EC50 was calculated by using the estimation model ECOSAR v1.11 implemented in EPISuite v4.11. The estimated 48h EC50 was 284 mg/L (BASF SE, 2018). The substance is within the model’s applicability domain. ECOSAR classifies the substance as a carbamate ester. Due to the poor database available for this chemical class, the substance was estimated with ECOSAR as a neutral organic.

 

Based on the available data EE-MOX (CAS 123403-95-2) is concluded to be with high probability acutely not harmful to aquatic invertebrates.

 

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 CAS 123403 -95 -2 (Q)SAR results were used for Acute Toxicity to Aquatic Invertebrates. 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 Acute Toxicity to Aquatic Invertebrates are not provided.