Registration Dossier
Registration Dossier
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EC number: 200-839-4 | CAS number: 75-10-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Only relevant modeled acute toxicity data is available for freshwater fish and aquatic invertebrates.Long- term toxicity test shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
Based on its physico-chemical properties and according to the distribution modeling, when released to the environment the majority of difluoromethane will partition into the air compartment (99.99%). Moreover difluoromethane is neither expected to sorb significantly to soil and sediment. nor to bioaccumulate in aquatic species due to its low potential for adsorption and bioaccumulation based on a measured log Kow of 0.21. So, Difluoromethane, when released to the environment, will enter almost exclusively into the ambient air; it has little tendency to partition to water, biota or soil. Because of its moderate sorption affinity, difluoromethane is expected to be mobile in soil. The most important degradation process occurs in the atmospheric compartment. Las but not least, a calculation with EpiWin software (US-EPA, 2009) suggests volatilization half-lives of about 45 minutes for rivers and 69 hours for lakes.
Volatilization from Water:
Henry LC: 0.292 atm-m3/mole (estimated by Bond SAR Method)
Half-Life from Model River: 0.7374 hours (44.25 min)
Half-Life from Model Lake : 68.52 hours (2.855 days)
The concerned substance is a gas of low toxicity and any impact on the aquatic environment is expected to be low. According to 9.1.2 Column 2 of REACH Annex VII the study need not be conducted if there are mitigating factors indicating that aquatic toxicity it unlikely to occur.
The calculated effect concentrations available for long-term toxicity in fish are reliable and the substance properties fall within the applicability domain of the QSARs, but the QSARs are not validated. The calculated effect parameters are therefore not used in the assessment.
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