Registration Dossier
Registration Dossier
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EC number: 201-207-0 | CAS number: 79-43-6
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- EC10 or NOEC for microorganisms:
- 12 250 mg/L
Additional information
For this endpoint, three studies are available. These studies were performed according to test guidelines which were replaced by updated test guidelines. Nevertheless, the results of the individual studies were considered as relevant with restrictions for the risk assessment. The study performed by the German Umweltbundesamt was considered as key study.
In the non-GLP key study from the Umweltbundesamt (1982), the growth inhibition of DCA on Pseudomonas putida was determined according to DIN 38412 (Bringmann and Kühn, 1980). Seven days prior to start of the exposure, the pre-culture was started. 18 hours prior to start, the preculture was cultured under test conditions. 11 concentrations of DCA with a spacing factor of 2 were set up. The test was performed for 18 hours at 25°C. At the end of the exposure, the growth of the cultures was determined by measurement of the optical density at 436 nm.
The EC10 was determined to be 12250 mg/L.
This result is considered to be reliable and relevant with restrictions for the risk assessment of DCA. The test design followed the most recent test guideline which were available at that time. In the recent ECHA Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment Table R.10-6, it is mentioned that information from this test should be used only if no other tests are available. The other available studies were performed according to the ETAD fermentation tube method and are of lower reliability than the key study and will not be discussed here in detail but were used as WoE. These tests demonstrated that the EC10 was 320 mg/L or higher.
In order to overcome the experimental uncertainty originating from the test design with Pseudomonas putida when following the test design of Bringmann and Kühn (1980), an additional safety factor of 10 to the assessment factor of 1 (as foreseen for the EC10 of the Pseudomonas putida test according to ISO-10712 (1996) is proposed to cover the uncertainty.
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