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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Link to relevant study record(s)

Description of key information

Overall it can be concluded, that the substance is not expected to be chronically harmful to fish

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
NOEC
Remarks:
Growth
Effect concentration:
36.2 mg/L
Fresh water fish
Dose descriptor:
NOEC
Remarks:
Mortality
Effect concentration:
56.6 mg/L

Additional information

QSAR-disclaimer

In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.

According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.

For the assessment of the pentane-1.5-diol (CAS 111 -29 -5) (Q)SAR results were used for the estimation of the acute toxicity to fish. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.

The Expert Judgement was performed in order to support the evidence, that the substance is not expected to be chronically harmful to fish. Further experimental studies are not provided.

 

Assessment

Long-term toxicity of pentane-1.5-diol to fish was evaluated by the QSAR Toolbox v4.4 calculation model. The 28-d NOEC for growth was determined to be 36.2 mg/L. The 28-d NOEC for mortality was determined to be 56.6 mg/L (BASF SE, 2021). The calculation was performed with the Trend analysis method and the substance was within the applicability domain of the calculation model.

Moreover, it can be concluded, that the available data on the substance’s toxicity and properties supports the sufficient evidence from several independent sources of information leading to the conclusion that the Substance does not have a particular dangerous property (see IUCLID Ch. 6.1.2: RSS: 'Expert Judgement_Long-term toxicity to fish'). This is also in agreement with Annex XI, Section 1.2 of Regulation (EC) No 1907/2006. Therefore, and in accordance with REACH Regulation 1907/2006, Annex XI, Section 1.2, further testing on vertebrate animals will be omitted for reasons of animal welfare. Therefore, further testing does not seem justified and long-term toxicity testing on fish should therefore not be carried out to avoid unnecessary testing on vertebrate animals. Avoiding unnecessary testing of vertebrate animals is also in line with the REACH regulation, which states in §25 that testing on vertebrate animal shall be undertaken as a last resort. This is further supported by the EU Directive on the protection of animals used for scientific purposes (Directive 2010/63/EU, of 22 September 2010) and the EURL ECVAM strategy to replace, reduce and refine the use of fish in aquatic toxicity and bioaccumulation testing (EURL ECVAM, 2014).

Overall it can be concluded, that the substance is not expected to be chronically harmful to fish.