Methyl 12-hydroxyoctadecanoate

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

According to Regulation (EC) No. 1907/2006, Column 2 of Annex IX, long-term toxicity testing in fish shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The substance is not expected to exhibit toxicity in the aquatic environment. The substance has a very low water solubility (i.e., 0.08994 mg/L) and is considered insoluble in water. Short-term toxicity was not observed in any of the aquatic toxicity tests conducted on an analogue substance through read-across at three trophic levels; in addition, long-term toxicity was not observed in algae. The substance has been determined to be readily biodegradable (i.e., 80% degradation in 28 d and meeting the 10-d window) and is not persistent in the environment; therefore, food chain exposures through secondary poisoning are not expected. Furthermore, studies conducted on analogue substances in higher vertebrates showed that the substance is not expected to exhibit acute oral toxicity, specific target organ toxicity through single or repeated dose oral exposure, genetic toxicity or reproductive toxicity. The substance is a short-chain alkyl ester of a naturally occurring fatty acid (i.e., the methyl ester of 12-hydroxystearic acid), and is expected to undergo catabolism by esterases and lipases in vivo; toxicokinetic studies conducted on analogue substances in mammals demonstrated a pharmacokinetic disposition comparable to that of endogenous triglycerides. Therefore, long-term toxicity testing in fish is waived.

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

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data waiving: supporting information

Description of key information

According to Regulation (EC) No. 1907/2006, Column 2 of Annex IX, long-term toxicity testing in fish shall be proposed if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The substance is not expected to exhibit toxicity in the aquatic environment. The substance has a very low water solubility (i.e., 0.08994 mg/L) and is considered insoluble in water. Short-term toxicity was not observed in any of the aquatic toxicity tests conducted on an analogue substance through read-across at three trophic levels; in addition, long-term toxicity was not observed in algae. The substance has been determined to be readily biodegradable (i.e., 80% degradation in 28 d and meeting the 10-d window) and is not persistent in the environment; therefore, food chain exposures through secondary poisoning are not expected. Furthermore, studies conducted on analogue substances in higher vertebrates showed that the substance is not expected to exhibit acute oral toxicity, specific target organ toxicity through single or repeated dose oral exposure, genetic toxicity or reproductive toxicity.  The substance is a short-chain alkyl ester of a naturally occurring fatty acid (i.e., the methyl ester of 12-hydroxystearic acid), and is expected to undergo catabolism by esterases and lipases in vivo; toxicokinetic studies conducted on analogue substances in mammals demonstrated a pharmacokinetic disposition comparable to that of endogenous triglycerides. Therefore, long-term toxicity testing in fish is waived.