Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish early-life stage toxicity
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 fish is expected. Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH), and considering animal welfare reasons,  the study on long-term toxicity to fish is considered scientifically not necessary and was hence waived.

Key value for chemical safety assessment

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 fish is expected.  Therefore, in accordance with section 3.2 a) of Annex XI to Regulation (EC) No 1907/2006 (REACH), and considering animal welfare reasons,  the study on long-term toxicity to fish 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.