1,2-epoxybutane

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Remarks:

Waiver

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

Based on the fate behavior of the substance and the outcome of the Chemical Safety Assessment no significant long term exposure of aquatic invertebrates is expected. Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH) the study on long-term toxicity to aquatic invertebrates is considered scientifically not necessary and was hence waived.

Additional information

JUSTIFICATION FOR DATA WAIVING

In accordance with section 3.2 a) in Annex IX of Regulation (EC) No 1907/2006 (REACH) the testing stipulated in Annex IX of the same regulation may be omitted, based on the exposure scenarios developed in the Chemical Safety Report. A thorough and rigorous exposure assessment in compliance with section 5 of Annex I of REACH demonstrated that no significant exposure in all scenarios of the manufacture and all identified uses occur. The PNECs were derived from results of available test data and in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.10 (Characterization of dose [concentration]-response for environment), taking full account of the increased uncertainty resulting from the omission of the information requirement. The derived PNECs are considered relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes. For the substance only industrial uses are considered. During the life-cycle of the substance procedural and control technologies are used that minimize emission and any resulting exposure. Only properly trained and authorized personnel handle the substance. In cases of accident and where waste is generated, procedural and/or control technologies are used to minimize emissions and the resulting exposure during purification or cleaning and maintenance procedures. The substance-handling procedures are well documented and strictly supervised by the site operator. Further, it should be emphasized that concluding all available data on biodegradation of 1,2-epoxybutane, the substance can be assessed as readily biodegradable according to OECD criteria. The bioaccumulation potential of 1,2-epoxybutane is very low as its log Kow is clearly below the threshold value of log 3 stated in REACH Annex IX, section 9.3.2, column 2. Moreover, by taking into consideration of the calculated log Koc adsorption of the substance to the sediment matrix is not expected. The comparison of the PNECs with the results of the exposure assessment showed that exposures are always well below the respective PNEC. In conclusion, based on the fate behavior of the substance and the outcome of the Chemical Safety Assessment no significant long term exposure of aquatic invertebrates is expected. Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH), the study on long-term toxicity to aquatic invertebrates is considered scientifically not necessary. This is also in line with the rule of information requirement adaptation as stated in Annex IX Section 9.1 column 2. Further testing does not appear to be scientifically necessary and was hence waived.