Registration Dossier
Registration Dossier
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EC number: 810-258-3 | CAS number: -
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
In accordance with REACH Annex IX, the requirement for studies of the effects on terrestrial organisms is waived on the basis of unlikely direct and indirect exposure of the soil compartment. No reliable measured terrestrial ecotoxicity data are available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes.
Key value for chemical safety assessment
Additional information
In accordance with REACH Annex IX, the requirement for studies of the effects on terrestrial organisms is waived on the basis of unlikely direct and indirect exposure of the soil compartment. In addition, other evidence presented in this dossier on the substance’s ready biodegradability, no acute or chronic toxicity to aquatic organisms and the absence of toxicity to mammals further support the waiver. No reliable measured terrestrial ecotoxicity data are available for Hydrocarbons, C12-C16, n-alkanes,isoalkanes,alkenes.
Exposure to Soils
It is unlikely that soil organisms will be exposed to Hydrocarbons, C12-C16, n-alkanes,isoalkanes, alkenes as there is no intended use involving the direct application of Hydrocarbons, C12-C16, n-alkanes,isoalkanes,alkenes to soil. In addition, it is unlikely that indirect exposure will occur, via the application of sewage sludge to land, as Hydrocarbons, C12-C16, n-alkanes,isoalkanes, alkenes is expected to biodegrade through the sewage treatment process.
Biodegradation
Hydrocarbons, C12-C16, n-alkanes,isoalkanes,alkenes has been shown in the reliable (Klimisch2) study by Russell (2006) to be readily biodegradable in water. The test substance biodegraded to an extent of 76.3% after 28 days and although the biodegradation rate just missed the 10-day window threshold, this aspect of the test is not applicable to mixtures where different components of the mixture can biodegrade preferentially (reference TG 103C). It is assumed that Hydrocarbons, C12-C16, n-alkanes,isoalkanes, alkenes will readily biodegrade in the environment and sewage treatment processes and be unavailable for uptake by soil organisms.
Toxicity to Aquatic Organisms
The acute and chronic toxicity of the test substance to aquatic organisms is very low based on the evidence presented in this dossier. No toxicity was observed in the experimental acute studies conducted with algae,daphnids and fish. In addition,PetroTox predicts that no chronic toxicity will be observed at the level of water for daphnids and fish. It is reasonable to assume that Hydrocarbons, C12-C16, n-alkanes,isoalkanes, alkenes will also exhibit similar toxicities to soil organisms resulting in a low hazard, which is not considered to be toxic (in PBT terms) to terrestrial life.
Toxicity to Mammals
Hydrocarbons, C12-C16, n-alkanes,isoalkanes,alkenesis not considered to be toxic to mammals based on the evidence presented in this dossier. Acute oral and acute dermal toxicities in rat were > 2000 and >2000 mg/kg, respectively based on the studies by Kuhn (2008) and Mihalcea (2015), respectively. Using this evidence it is assumed that Hydrocarbons, C12-C16, n-alkanes,isoalkanes, alkenes is not considered to be toxic (in PBT terms) to mammals and it is reasonable to assume that it is unlikely to be hazardous to birds.
In summary, the data requirement for terrestrial ecotoxicity testing is waived on the evidence of lack of direct or indirect exposure to soil organisms, ready biodegradability in the environment and the absence of toxicity in aquatic organisms and mammals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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