Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

Based on weight of evidence approach the no.of studies were reviewed for short-term toxicity to fish from reliable sources having Klimish rating 2 and 4.

The summary of the results are presented below

Sr. No

Endpoint

Value

Duration

Basis of effect

Species

Sources

1.

LC50

4.67 mg/L

 96 hr.

Mortality

Carassius auratus

Predicted data from QSAR for CAS : 506-30-9

2.

LC50

12 mg/L

96 hr.

Mortality

Oncorhynchus kisutch

Experimental data for RA CAS : 57-11-4

3.

LC50

>5 mg/L

96 hr.

Mortality

Oryzias latipes

Experimental data from study report for RA CAS : 112-85-6

4.

LC50

40 mg/L

48 hr

Mortality

Oryzias latipes

Experimental data for RA CAS : 8002-13-9

 

Based on the studies summarized in the above table for the target substance Eicosanoic acid and the read across substance,the endpoint value was found to vary between lethal concentration (LC50) = 4.67 mg/L to 40 mg/L in a 48 hrs. to 96 hrs.study on the basis of mortality effect. Based on the LC50 values, the substance may qualify for the aquatic classification.But after compairing with other CLP criteria for BCF and biodegradation it is concluded that Eicosanoic acid does not exhibit short term toxicity to fish (Carassius auratus, Oncorhynchus kisutch and Oryzias latipes) i.e. it is non hazardous to the aquatic environment.

Long-term toxicity to fish

According to annex IX of column I , Long-term toxicity testing on fish need not to be conducted as it is already provided as part of Annex VIII requirements.Therefore this study was considered to be waived.

Short-term toxicity to aquatic invertebrates

Based on weight of evidence approach the no.of studies were reviewed for short-term toxicity to aquatic invertebrates from reliable sources having Klimish rating 2 and 4.

The summary of the results are presented below

Sr. No

Endpoint

Value

Duration

Basis of effect

Species

Sources

1.

LC50

5.7 mg/L

 48 hr.

Mortality

Daphnia magna

Predicted data from QSAR for CAS : 506-30-9

2.

EC50

1.22 mg/L

48 hr.

Immobilization

Daphnia magna

Predicted data from QSAR for CAS : 506-30-9

3.

EC50

>5 mg/L

48 hr.

Immobilization

Daphnia magna

Experimental data from study report for RA CAS : 112-85-6

4.

LC50

40 mg/L

3 hr

Mortality

Daphnia pulex

Experimental data for RA CAS : 8002-13-9

 

Based on the studies summarized in the above table for the target substance Eicosanoic acid and the read across substance,the endpoint value was found to vary between lethal concentration (LC50) = 5.7 mg/L to 40 mg/L and effective concentration (EC50) = 1.22 mg/L to >5 mg/L in a 3 hrs. to 48 hrs.study on the basis of mortality and immobilization effect. Based on the LC50 and EC50 values, ,the substance may qualify for the aquatic classification.But after compairing with other CLP criteria for BCF and biodegradation it is concluded that Eicosanoic acid does not exhibit toxicity to aquatic invertebrate (Daphnia magna and Daphnia pulex ) i.e. it is non hazardous to the aquatic environment.

Long-term toxicity to aquatic invertebrates

According to column I of annex IX ; Long-term toxicity testing on invertebrate (species : Daphnia magna) need not to be conducted as it is already provided as a part of Annex VII requirements.Therefore this end point was considered for waiver.

Toxicity to aquatic algae and cyanobacteria

No. of studies were reviewed for toxicity to aquatic algae and cyanobacteria from reliable sources having Klimisch rating 2 and 4.

The summary of the results are presented below  

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Sources

1

EC50

3.806 mg/L

Population

96 hrs.

Pseudokirchnerella subcapitata

Predicted data from QSAR for target CAS : 506-30-9

2

EC50 and

5 mg/L

Growth rate

72 hrs.

Selenastrum capricornutum (new name: Pseudokirchnerella subcapitata)

Experimental data from the study report for RA CAS : 112-85-6

NOEC

5 mg/L

Growth rate

72 hrs.

Selenastrum capricornutum (new name: Pseudokirchnerella subcapitata)

Experimental data from the study report for RA CAS : 112-85-6

3

NOEC

4.1 mg/L

Growth rate

72 hrs.

Pseudokirchnerella subcapitata

Experimental data from the study report for RA CAS : 112-85-6

 

Based on the studies summarized in the above table for the target substance Eicosanoic acid and the read across substance,the endpoint value was found to vary between EC50 = 3.806 mg/L to 5 mg/L and NOEC = 4.1 mg/L to 5 mg/L in a 72 hrs. to 96 hrs. study on the basis of growth rate and population effect. Based on the EC50 values ranging from 3.806 mg/L to 5 mg/L,the substance may qualify for the aquatic classification.But after compairing with other CLP criteria for BCF and biodegradation it is concluded that Eicosanoic acid does not exhibit toxicity to algae (Pseudokirchnerella subcapitata) i.e. it is non hazardous to the aquatic environment.

Toxicity to microorganisms

No. of studies were reviewed for toxicity to microorganisms from reliable sources having Klimisch rating 2.

The summary of the results are presented below  

Sr.No

Endpoint

Effect values

Basis for effects

Duration

Species

Sources

1

EC50

5.85 mg/L

Population

24 hr.

Tetrahymena pyriformis

Predicted data from QSAR for target CAS : 506-30-9

2

EC50

75.387 mg/L

-

15 min.

Vibrio fisheri

Experimental data from Environmental Toxicology and Water Quality for RA CAS : 57-10-3

 

Based on the studies summarized in the above table for the target substance Eicosanoic acid and the read across substance, in microorganisms (Tetrahymena pyriformis and Vibrio fisheri),the endpoint value was found to vary between EC50 = 5.85 mg/L to 75.387 mg/L in a 15 min. to 24 hr. study on the basis of population effect.