Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
activated sludge respiration inhibition testing
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because there is no emission to a sewage treatment plant
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The substance is a gas, no emission to sewage tretment plant.
Endpoint:
toxicity to microorganisms
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a study is available (Klimish score=4 because secondary source)
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Analytical monitoring:
yes
Key result
Duration:
6 h
Dose descriptor:
EC50
Effect conc.:
> 472.57 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Remarks on result:
other: Based on a read-across from an analogue from which EC50 > 730 mg/L.
Conclusions:
Based on the read-across approach from the analogue 1,1,1,2-tetrafluoroethane, the EC50 of 1,1-difluoroethane was determined to be > 472.57 mg/l based on growth inhibition.
Executive summary:

A bacterial growth inhibition test was carried out with the analogue substance 1,1,1,2 -tetrafluoroethane on Pseudomonas putida.

HFC-134a showed a low toxicity towards P. putida. At the highest mean measured HFC-134a concentration of 730 mg/l no inhibition of the growth of P.putida was found during a period of 6 h and therefore, the EC50 based on growth inhibition was determined to be > 730 mg/l. On the basis of these results, the read-across approach was applied and the EC50 based on growth inhibition of 1,1 -difluoroethane was determined to be > 472.57 mg/l.

Description of key information

Data waiving: In accordance with Column 2 adaptation statement of REACH Annex VIII the study does not need to be conducted if there as no emission to a sewage treatment plant.

Key value for chemical safety assessment

Additional information

Data waiving: In accordance with Column 2 adaptation statement of REACH Annex VIII the study does not need to be conducted if there as no emission to a sewage treatment plant.

Supporting study: A bacterial growth inhibition test was carried out with the analogue substance 1,1,1,2 -tetrafluoroethane on Pseudomonas putida. Based on the read-across approach from the analogue 1,1,1,2-tetrafluoroethane, the EC50 of 1,1-difluoroethane was determined to be > 472.57 mg/l based on growth inhibition.