Methyl 12-hydroxyoctadecanoate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

07 January 1991 to 11 January 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

analytical monitoring not conducted

Justification for type of information:

The analogue approach is used for the hazard assessment of toxicological, eco-toxicological and environmental fate endpoints for the registration of 12-hydroxstearate methyl ester (CAS 141-23-1). The hypothesis is that data can be read-across between this ester and its structural analogues, based on structural similarity and which cause the same type of effect(s) in physical and biological systems (Scenario 2 of the Read-Across Assessment Framework (RAAF, ECHA, 2015). The primary fatty acid ester in this read-across for environmental fate and ecotoxicological endpoints is methyl myristate (C14), as this substance is well-studied with high-quality experimental data. Supplemental analogues are used which contribute understanding of the effects of other structural features not contained in the two primary analogues.

The substance and its analogue have not been shown to exhibit toxicity to aquatic organisms (based on short-term studies on all three trophic levels) or be inhibitory to degradative micro-organisms. Both the substance and its analogue have been shown to be readily biodegradable and are not expected to be highly persistent in the environment. And, although both substances exhibit low solubility and a high octanol-water partition coefficient, neither substance is expected to bioaccumulate and pose a concern for food chain exposures, due to the metabolism by carboxylesterases and lipases in vertebrate and invertebrate systems.

There are no GHS classifications for 12-hydroxstearate methyl ester for endpoints which are reliant on read-across. There is a high degree of confidence that hazards for these endpoints are not underestimated, based on a strong weight of evidence from multiple data sources.

Read-across data, all evaluated as reliable according to Klimisch scores of 1 or 2, were used to estimate the toxicity of the registered substance for fulfilling the data requirements of the REACH registration and classifying potential hazards. This read-across approach is adequate for the purposes of risk assessment and classification and labeling.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Version / remarks:

listed as ISO-guideline 7346/2 which conforms to OECD guideline 203

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

Study followed ISO-guideline 4346/2 which conforms to OECD 203, 1984.

Deviations:

not specified

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1 700 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Based on the insoluble test material mixed using ultrasound and ultraturrax methods.

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

3 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Based on the insoluble test material mixed using ultrasound and ultraturrax methods.

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Based on the insoluble test material mixed using ultrasound and ultraturrax methods.

Conclusions:

Exposure of test organisms (zebra fish) to concentrations ranged from 1,000 mg/L to 10,000 mg/L of the test substance. The study reported a 96-h NOEC = 1,000 mg/L, above the threshold of concern of 100 mg/L in short-term aquatic studies. Additionally, the study reported values for the 96-h LC50 = 1,700 mg/L and the 96-h LC100 = 3,000 mg/L, although these values are not indicative of short-term toxicity to fish.

Description of key information

The key study was a semi-static acute fish toxicity test on the effects of an analogue substance on the freshwater zebra fish Danio rerio (previously Brachydanio rerio) following ISO-guideline 7346/2 which conforms to OECD Guideline 203.  Exposure of test organisms (zebra fish) to test concentrations ranged from 1,000 mg/L to 10,000 mg/L. The study reported a 96-h NOEC = 1,000 mg/L, above the threshold of concern of 100 mg/L in hort-term aquatic toxicity studies. Additionally, the study reported values for the 96-h LC₅₀ = 1,700 mg/L and the 96 -h LC₁₀₀ = 3,000 mg/L, although these values are not indicative of short-term toxicity to fish.

 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 700 mg/L