Registration Dossier
Registration Dossier
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EC number: 947-850-7 | CAS number: -
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- adult fish: sub(lethal) effects
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2 no further long-term toxicity testing to fish is proposed.
The substance is determined to be readily biodegradable and according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs) (ECHA, 2017). Thus, discharged concentrations to the aquatic environment are expected to be very low.
One long-term study with aquatic invertebrates is avaible for a read-across substance. As aquatic invertebrates are the most sensitive organism and no lower effect concentrations are expected for long-term fish compared to long-term invertebrates, no further long-term study is required for fish. Furthermore, to animal welfair a test with vertebrates should be avoided. In addition, the environmental exposure assessment for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7)indicates no risk for the aquatic compartment (all RCR < 1; please refer to Chapter 9 and 10 of the Chemical Safety Report for detailed information). According to Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b: Endpoint specific guidance (ECHA, 2017) long-term fish testing is not necessary, if PEC/PNEC is < 1 based on the Daphnia long-term result.
Furthermore, the substance has a low potential for bioaccumulation (see chapter 5.3.1), i.e. based on log D < 4.5, metabolisation and excretion and BCF values of 10 – 421.7 L/kg wet-wt (EPI Suite v4.11 and VEGA v1.2.3). Thus, the substance is not expected to bioaccumulate in aquatic species.
Based on all available data, chronic exposure of aquatic organisms is unlikely. Based on the results of the chemical safety assessment and the low bioaccumulation potential no further long-term test with freshwater fish is proposed for Reaction mass of N-(1-oxooctadecyl)sarcosine and N-hexadecanoyl-N-methylglycine (EC 947-850-7).
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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