Registration Dossier
Registration Dossier
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EC number: 268-452-3 | CAS number: 68092-28-4
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
LL50 (96 h) > 100 mg/L
NOELR = 100 mg/L
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
This endpoint was addressed using a read across approach to structural analogues of the registered substance. The two analogues chosen for this endpoint are Tall oil and Diethanolamine (DEA). The justification of choosing these two analogues is provided in detail in the document "Tall oil compound with diethanolamine -- read across justification based on the Read-Across Assessment Framework (RAAF) document", attached in section 13 of this dossier. Two key studies are provided, one on tall oil and one on diethanolamine. In this respect it is considered that the data submitted provides an adequate reflection of the properties of the registered substance.
A limit test was carried out to assess the acute toxicity potential of the read across substance distilled tall oil toDanio rerioin accordance with the standardised guideline OECD 203 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).
The fish were exposed to a 100 mg/L loading rate WAF of the test material for 96 hours under semi-static conditions. Fish were observed for any effects on mortality and additionally for any sub-lethal and behavioural effects.
No mortality was seen throughout the test period, nor were any sub-lethal effects noted.
Under the conditions of this study, the 96 hour LL50 was determined to be > 100 mg/L and the NOELR to be 100 mg/L based on exposure to a WAF of the test material. No classification of the test material is required in accordance with EU criteria.
The second key study investigates the acute toxicity potential of the read across substance diethanolamine to Pimephales promelas in accordance with the standardised guideline ASTM-Standard E 729-80 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).
Fry, juveniles and subadults were exposed to the test material for 96 hours under static conditions.
Under the conditions of this study, the 96 hour LC50 of the test material to fathead minnows was determined to be 1460 mg/L. The test material requires no classification in accordance with EU criteria.
Under the conditions of these studies, neither the tall oil nor diethanolamine component of the test material requires classification for acute toxicity. On this basis, and as a precautionary measure, the overall determination that will be carried forward for risk assessment of the registered substance will be the 96 hour LL50 of > 100 mg/L and NOELR of 100 mg/L based on exposure to a WAF of the test material.
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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