Registration Dossier
Registration Dossier
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EC number: 213-497-6 | CAS number: 959-26-2
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- The basis for this read-across approach is that the target substance is expected to undergo transformation into terephthalic acid (CAS No. 100-21-0) and ethane-1,2-diol (CAS No. 107-21-1). The toxicity of the transformation products will accurately predict the toxicity of the bis(2-hydroxyethyl)terephthalate (CAS No. 959-26-2). Refer to the JUSTIFICATION FOR READ-ACROSS OF TOXICOLOGICAL INFORMATION in Section 13 of this dossier for further details.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- Prediction based on the toxicity of the transformation products terephthalic acid (100-21-0) and ethylene glycol (107-21-1)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 6 mmol/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 530 mg/L
- Details on results:
- The 96h fish LC50 for terephthalic acid is reported as > 1000 mg/L (> 6.0 mmol/L)
The 24h fish LC50 for ethylene glycol is reported as > 5000 mg/L (> 80.6 mmol/L)
Based on a conservative prediction, the 96h fish LC50 of BHET is predicted to be > 1530 mg/L (>6.0 mmol/L). - Validity criteria fulfilled:
- not applicable
- Remarks:
- Prediction based on analogue approach
- Conclusions:
- Based on a conservative prediction, the 96h fish LC50 of BHET is predicted to be > 1530 mg/L.
- Executive summary:
No short-term toxicity on fish data was available for BHET. The short-term toxicity on fish of terephthalic acid was assessed in Leuciscus idus melantotus (Golden Orfe) in a GLP-compliant study according to OECD 203. No mortalities or behavioural changes were noted at any concentration during the study. The reported 96h LC50 was greater than 1 000 mg/L or greater than 6.0 mmol/L. The toxicity of ethylene glycol to Carassius auratus (goldfish) was assessed in a study similar to OECD 203 which pre-dates GLP. The reported 24h LC50 was greater than 5 000 mg/L or greater than 80.6 mmol/L. Information on the source substances is considered to be directly applicable to an equivalent molar amount of the target substance; therefore, the 96h LC50 of BHET was predicted to be greater than 6.0 mmol/L or greater than 1 530 mg/L.
Reference
Description of key information
Based on a conservative prediction, the 96h fish LC50 of BHET is predicted to be > 1530 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 1 530 mg/L
Additional information
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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