Registration Dossier
Registration Dossier
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EC number: 203-354-6 | CAS number: 106-02-5
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
Read-across (EU Number: 422-320-3), OECD Guideline 209, EU Method C.11, GLP, key study, validity 2:
The test substance was not toxic to activated sludge (3h-EC50 >> 100 mg/L). 3h-NOEC ≥ 100 mg/L.
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 100 mg/L
Additional information
Two valid studies are available to assess the toxicity of the substance to microorganisms.
The first study (Dengler, 2005), assessed as the key study, was performed according to OECD Guideline 209 and EU Method C.11 with GLP statement on the read-across substance (EU Number: 422-320-3). The respiration rate of activated sludge, fed with a standard amount of synthetic sewage feed, was measured after 30 minutes and 3 hours of contact in presence of the test substance. The inhibitory effect of the test substance at a particular concentration was expressed as a percentage of the mean respiration rate of two controls. In a range-finding test which preceded the main test, no inhibitory effects were observed after 3 hours from 0.01 to 100 mg/L (the maximum concentration used in the study) of the test substance. There was no inhibitory effect of the test item at any concentration. The EC50 and NOEC were above 100 mg/L.
The second study (Caspers, 1996), assessed as the supporting study, was performed according to ISO Guideline 8192, similar to OECD Guideline 209 with GLP statement on the registered substance. The measured parameter was respiration rate by measuring the concentration of O2 in the test system. Three concentrations of the substance were tested in mg/L: 100, 1000, and 10000; plus a negative and a positive control. No deviation from the negative control was observed, whatever the substance concentration, therefore the EC50 is considered to be greater than 10 000 mg/L.
In conclusion, according to the key study and as the supporting substance is considered adequate for read-across purposes (see Iuclid section 13 for justification), the key NOEC value used for chemical safety assessment is 100 mg/L as a worst case value.
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