Sorbitan monostearate, ethoxylated

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to fish, other

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Experimental data of test chemicals

Justification for type of information:

Experimental data of various test chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two long term toxicity study of fish for the test chemical:
1. and 2. Long-term toxicity to fish of test material

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Fish

Test type:

static

Water media type:

freshwater

Total exposure duration:

14 d

Reference substance (positive control):

no

Key result

Duration:

14 d

Dose descriptor:

other: LC50

Effect conc.:

> 50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Other details not known

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 5 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Other details not known

Validity criteria fulfilled:

no

Conclusions:

The test chemical is not likely to be toxic to fish atleast in the concentration range of 50 mg/l

Executive summary:

Data available for the test chemicals has been reviewed to determine the long term toxicity of fish .The studies are as mentioned below:

Long term toxicity study was evaluated for test material according to OECD Guideline 204 (Fish, Prolonged Toxicity Test) for 14 days. The effect concentration for test material after 14 days study on fish was observed to be > 50 mg/l. Thus, it can be concluded that effect concetration value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test material cannot be classified for long term toxicity for fish.

First study was supported by the second. The long term toxicity of test material was evaluted for fish according to OECD 204 prolong toxicity to fish for 14 days. Based on the mortality of fish by chemical, the no observed effect concentration (NOEC) and (EC50) was observed to be > 5 mg/l. On the basis of above effect concentrations, chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

Thus, based on the above summarised studies, it can be concluded that effect concetration value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for long term toxicity for fish .

Description of key information

The test chemical is not likely to be toxic to fish atleast in the concentration range of 50 mg/l

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5 mg/L

Additional information

Data available for the test chemicals has been reviewed to determine the long term toxicity of fish .The studies are as mentioned below:

Long term toxicity study was evaluated for test material according to OECD Guideline 204 (Fish, Prolonged Toxicity Test) for 14 days. The effect concentration for test material after 14 days study on fish was observed to be > 50 mg/l. Thus, it can be concluded that effect concetration value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test material cannot be classified for long term toxicity for fish.

First study was supported by the second.The long term toxicity of test material was evaluted for fish according to OECD 204 prolong toxicity to fish for 14 days. Based on the mortality of fish by chemical, the no observed effect concentration (NOEC) and (EC50) was observed to be > 5 mg/l. On the basis of above effect concentrations, chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

Thus, based on the above summarised studies, it can be concluded that effect concetration value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for long term toxicity for fish .