Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-204-8 | CAS number: 10595-49-0
Endpoint summary
Administrative data
Description of key information
Additional information
A reliable (Klimisch 1 or 2) toxicity study is available for test substance, CAS number 10595-49-0, on microorganisms. Reliable short-term toxicity studies for fish, invertebrates, and algae are not available for 10595-49-0 but have been conducted for the structural analogue, KEU4587 (CAS 94313-91-4) and are included in this dossier. These Key studies are summarized below. Long term toxicity tests are not available for 10595-49-0, however again a long-term study for the structural analogue 94313-91-4 has been relied upon for long term toxicity to algae. For fish and invertebrates, long-term toxicity of 10595-49-0 has been modelled using ECOSAR. There were no reliable long-term toxicity data aquatic plants. However, a waiver is justified for these endpoints.
A reliable short-term toxicity study with fish is not available for 10595-49-0. However, a reliable (Klimisch 1) short-term toxicity study with fish has been conducted the analogue, KEU4587 (CAS 94313-91-4) and is included in this dossier. Liedtke (2009) reports an LC50 for short term toxicity in fish of >251.3 mg/L. This value will be taken as the short-term toxicity in fish endpoint for 10595-49-0.
No reliable long-term toxicity data are available for the toxicity of 10595-49-0 to fish. However modelled data are available and included in the dossier. Ramboll (2019) undertook a reliable (Klimisch 2) study for 10595-49-0 using the QSAR model, Ecological Structure Activity Relationships (ECOSAR) Class Program to estimate long-term toxicity to fish. The ECOSAR model estimates aquatic toxicity based on the structural similarity to chemicals for which aquatic studies are available. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 0.021 mg/l for amides and is the lowest of the three groups. Based on ECHA guidance R.10 a NOEC can be derived from a Chronic Value by dividing the ChV by the √2. Based on this approach the NOEC for fish toxicity is 0.015 mg/L and consequently will be taken for the long-term toxicity to fish endpoint.
A reliable short-term toxicity study with invertebrates is not available for 10595-49-0. However, a reliable (Klimisch 1) short-term toxicity study with invertebrates has been conducted the analogue, KEU4587 and is included in this dossier. Liedtke (2009) reports an EC50 for short term toxicity in Daphnia magna of 136 mg/L. Consequently, this value will be taken as the short-term toxicity in invertebrates endpoint for 10595-49-0.
No reliable long-term toxicity data are available for the toxicity of 10595-49-0 to invertebrates. However modelled data are available and included in the dossier. Ramboll (2019) undertook reliable (Klimisch 2) modelling for 10595-49-0 using the QSAR model, Ecological Structure Activity Relationships (ECOSAR) Class Program to estimate long-term toxicity to invertebrates. The ECOSAR model estimates aquatic toxicity based on the structural similarity to chemicals for which aquatic studies are available. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 0.052 mg/L for aliphatic amines and is the lowest of the three groups. Based on ECHA guidance R.10 a NOEC can be derived from a Chronic Value by dividing the ChV by the √2. Based on this approach the NOEC for invertebrate toxicity is 0.037 mg/L and consequently will be taken for the long-term toxicity to invertebrates endpoint.
A reliable toxicity study with algae is not available for 10595-49-0. However, a reliable (Klimisch 1) toxicity study with algae has been conducted on the analogue, KEU4587 and is included in this dossier. Liedtke (2010) reports a 72-hr LC50 for toxicity in Pseudokirchneriella subcapitata of 0.097 mg/L and a 72-hr NOEC of 0.016 mg/L, based on growth. Consequently, these values will be taken as the toxicity in algae endpoint for 10595-49-0. Chronic algae toxicity was also modelled using QSAR, however the modelled chronic value was 0.11 mg/L (calculated NOEC of 0.078 mg/L) which was greater than measured value with KEU 4587 and therefore the more conservative measurement has been applied.
A reliable toxicity study with microorganisms is available for 10595-49-0 and is included in this dossier. Clarke (2012) reports a 3-hr EC50 for toxicity to microorganisms of 80 mg/L and a 3-hr NOEC of 32 mg/L. Consequently, these values will be taken as the toxicity in microorganisms endpoint for 10595-49-0.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
