Sorbitan monostearate, ethoxylated

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

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 various test chemicals

Justification for type of information:

Data is from collection of data

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 aquatic invertebrate for the test chemical :
1. and 2. Long term toxicity study of test material was performed

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

- Common name: Water flea

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

21 d

Reference substance (positive control):

not specified

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

1.5 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: Other details not known

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 0.55 - < 2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

reproduction

Validity criteria fulfilled:

no

Conclusions:

The test chemical is not likely to be toxic to invertebrate in long term atleast in the concentration range of 0.55 - 2 mg/l.

Executive summary:

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

The long term study of test material on aquatic invertebrate daphnia magna was performed to evalute its effect on reproduction efficiency of daphnia magna according to OECD Guideline 211 (Daphnia magna Reproduction Test). The EC50 of test material after 21 days was observed to be in the range of 0.55 - 2.1 mg/l. The no effect concentration (NOEC) was observed to be 0.55 mg/l. On the basis of above effect EC50 value chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

First study was supported by the second study from authoritative study. Long term toxicity of test chemical on invertebrate daphnia magna study was performed for 21 days according to OECD Guideline 211 (Daphnia magna Reproduction Test). Based on the effect observation on the daphnia magna after exposure period of 21 days, the EC50 was observed to be 1.5 mg/l, the NOEC was observed to be 0.48 mg/l. On the basis of above value it can be considered that the chemical was non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

Thus based on the above effects, chemical consider to be nontoxic and not classified sa per the CLP classification criteria.

Description of key information

The test chemical  is not likely to be toxic to invertebrate in long term atleast in the concentration range of 1.5 - 2 mg/l.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.55 mg/L

Additional information

Data available for the test chemicals and structurally similar read across chemical, study has been reviewed to determine the long term toxicity of test chemical on aquatic invertebrate .The studies are as mentioned below:

 

The long term study of test material on aquatic invertebrate daphnia magna was performed to evaluate its effect on reproduction efficiency of daphnia magna according to OECD Guideline 211 (Daphnia magna Reproduction Test). The EC50 of test material after 21 days was observed to be in the range of 0.55 - 2.1 mg/l. The no effect concentration (NOEC) was observed to be 0.55 mg/l. On the basis of above effect EC50 value chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

 

First study was supported by the second study from authoritative study. Long term toxicity of test chemical on invertebrate daphnia magna study was performed for 21 days according to OECD Guideline 211 (Daphnia magna Reproduction Test). Based on the effect observation on the daphnia magna after exposure period of 21 days, the EC50 was observed to be 1.5 mg/l, the NOEC was observed to be 0.48 mg/l. On the basis of above value it can be considered that the chemical was non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

 

Thus based on the above effects, chemical consider to be nontoxic and not classified as per the CLP classification criteria.