Registration Dossier
Registration Dossier
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EC number: 214-492-1 | CAS number: 1135-40-6
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
Toxicity to microorganisms: EC0 ≥ 92 mg/L, NOEC ≥ 92 mg/L over 28 days for activated sludge of a predominantly domestic sewage (OECD 301F)
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 92 mg/L
Additional information
To cover this endpoint the toxicity control data from the (for this endpoint) Klimisch 2 OECD 301F study has been used, revealing EC0, NOEC ≥ 92 mg/L (28d) - which is the only dose tested in the OECD 301F - and sufficiently reliable to assess the toxicity of CAPS to microorganisms. This is in line with the endpoint specific guidance R7b (v 3.0, Febr. 2016), where the following is stated regarding toxicity on STP microorganisms and the use of data from biodegradation tests (second criteria applicable for CAPS):
"The information content of ready or inherent biodegradability tests can also be used to derive a NOEC under the following conditions:
• when in a ready or inherent biodegradability test the compound is found to be respectively readily or inherently biodegradable,
• when in a ready or inherent biodegradability test a toxicity control has been included that shows good degradation of a positive control substance (e.g. glucose, sodium acetate) in the presence of the test substance."
The toxicity control attained 43 % after 14 days and 53.8 % degradation at the end of the test. If degradation in the toxicity flask is below 25% after 14 days, the test item can be considered as toxic towards the inoculum. This is not the case here. With regard to the CLP Regulation 1272/2008, the results do not trigger classification of CAPS as hazardous to the environment, as it isn't part of the classification criteria. Accordingly, it can be considered as harmless to the aquatic environment. There is no indication given that the results from this study are not reliable, the data requirements according to REACH Annex VIII are met and no need for further testing was identified.
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