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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached analogue justification provided in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
WAF
Basis for effect:
mortality (fish)
Remarks on result:
other: Source: CAS 68583-51-7
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 14 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
WAF
Basis for effect:
mortality (fish)
Remarks on result:
other: Source: CAS 853947-59-8

Description of key information

No short term toxicity towards fish based on read across from CAS 68583-51-7 and CAS 853947-59-8

Key value for chemical safety assessment

Additional information

There is no study available, in which the short-term toxicity of propylene dinonanoate (CAS 41395-83-9) to fish was investigated. Therefore, read-across to the structurally related source substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5. The source substances are characterized by similar fatty acid chain lengths as well as alcohol components and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to fish. A detailed read-across justification is provided in the analogue justification in IUCLID section 13.

All available studies with the source substances were performed according to appropriate EU guidelines and GLP.

One experimental study investigating the short-term toxicity of the source substance decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) to fish is available (1995). The limit test was performed according to the EU Method C.1 (and GLP) with the zebrafish Brachydanio rerio under semi-static conditions. A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since the test solutions were determined to be oversaturated. Hence the effect concentration was based on the nominal loading rate. On this basis, an LL50 (96 h) of > 1000 mg/L (nominal, WAF) was determined.

The available study with the source substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted according to the EU Method C.1 and GLP. Cyprinus carpio was exposed to a single nominal loading rate of 1000 mg test item/L and a control for 96 h. The test type was semi-static and the stock solution of 1 g/L was prepared by stirring for 18 h and was subsequently filtered. Fresh test solutions were prepared daily. The stability of the substance in the medium was monitored by TOC measurement every 24 h before change of test solutions. Due to moderate analytical recoveries the effect values were expressed in terms of mean measured test concentrations. The test did not reveal any effects towards fish and therefore an LC50 (96 h) > 14 mg/L (arithm. mean meas.) was derived. Thus, no effects on fish up to the water solubility limit is expected.

All data with the source substances consistently showed no toxicity effects towards fish up to the water solubility limit. Based on the structural and chemical similarity of the target and source substances, the target substance is expected to exhibit a similar ecotoxicological profile. Therefore, it can be concluded that propylene dinonanoate (CAS 41395-83-9) will not cause short-term effects to fish up to the limit of water solubility.