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Description of key information

There is data available from the read-across substance 2-Oxepanone, polymer with 1,4-butanediol for four aquatic studies 1) acute toxicity to zebra fish using semi-static conditions and 2) acute toxicity to Daphnia magna 3) growth rate inhibition on Pseudokirchneriella subcapitata 4) toxicity to the bacteria Pseudomonas putida.

Based on calculated concentrations the acute 96-hour LC50, NOEC and LC100 values for zebra fish were 72, <18 and 140 mg Capa-203/L, respectively.

The 48-hour LC50 for Daphnia magna was found to be 290 mg/l, while the NOEC was found to be 100 mg Capa 2043/L.

For the 72 -hour algal inhibition study a NOEC of 25 mg/L was calculated, along with an ErC50 of 165 mg Capa 2043/L.

The NOEC for Pseudomonas putida was considered to be equal to the maximum tested concentration of 461 mg Capa-203/L.

In the chemical safety assessment performed according to Article 14(3) in connection with Annex I section 3 (Environmental Hazard Assessment) no hazard was identified. Therefore according to REACH Annex I (5.0) exposure estimation is not necessary. Consequently, in accordance with Column 2 of REACH Annex IX, long term studies do not need to be conducted as all identified uses of the substance are assessed as safe for the environment.

Additional information

It is considered appropriate to address the aquatic toxicity data requirement for 2-oxepanone, polymer with 1,6-hexanediol by applying read-across from available experimental study data on 2-oxepanone, polymer with 1,4-butanediol. The source and target substances are low molecular weight polyester diols terminated by primary hydroxyl groups and are structurally similar in that they both contain 6-hydroxyhexanoic acid repeating units. The linking unit is 1,4-butanediol in 2-oxepanone, polymer with 1,4-butanediol and 1,6-hexanediol in 2-oxepanone, polymer with 1,6-hexanediol. The diols differ by two carbons in the aliphatic chain and are therefore sufficiently structurally similar to support a read-across approach. The source and target substances share similar physico-chemical properties in that both are liquids at room temperature and have similar water solubility and log Pow values. The substances are therefore sufficiently similar in terms of basic physico-chemical properties to support a read-across approach. A read-across justification document is attached in section 13.