Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short term toxicity to fish:

No of studies were reviewed for Short-term toxicity to fish from reliable sources having Klimish rating 2.

The summary of the results are presented below:

Sr. No.

Endpoint name

Duration

Value

Units

Species

Source

1.     

LC50

96 hr

>0.18

mg/L

Pimephales Fathead minnow

Experimental data

2.     

LC50

96 hr

>0.12

mg/L

Lepomis macrochirus

Experimental data

3.     

LC50

96 hr

>0.11

mg/L

Channel catfish

Experimental data

 

The LC50 value predicted by publication indicates that D&C Yellow No. 11 does notexhibit aquatic toxicity to fish based on the CLP criteria for classification of the substance.

Short term toxicity to aquatic invertebrates:

No of studies were reviewed for Short term toxicity to invertebrates from reliable sources having Klimish rating 2.

The summary of the results are presented below:

Sr. No.

Endpoint name

Duration

Value

Units

Species

Basis of effect

Sources

1.     

EC50

48 hr

>0.17

mg/L

Daphnia magna

Mortality

Experimental data

2.     

EC50

48 hr

>0.17

mg/L

Midge larva

Mortality

Experimental data

3.     

EC50

48 hr

>0.18

mg/L

Mayfly larva

Mortality

Experimental data

 

The above values suggest that D&C Yellow No. 11 is not classified as per CLP criteria.

Short term toxicity to aquatic algae and cyanobacteria:

The effective concentration (EC50) value based on QSAR prediction of D&C Yellow No. 11 (CAS No 8003-22-3) in aquatic algae(Scenedesmus subspicatus (new name: Desmodesmus subspicatus)) in 72 hrs was estimate to be 0.47465 mg/l. Also in aquatic algae(Pseudokirchnerella subcapitata) in 72 hrs was estimate to be4.8425 mg/l

Therefore the EC50 was considered to be0.47465mg/L for D&C Yellow No. 11 and it is not readily biodegradable in nature indicating that test substance likely to exhibit toxicity to aquatic algae in aquatic chronic 1 category as per the CLP criteria.

Short term toxicity to microorganisms :

In toxicity to microorganism study for D&C Yellow No. 11 (CAS No 8003-22-3) the growth inhibition effect was evaluated by using QSAR model, the effect concentration (EC50) of D&C Yellow No. 11 was estimated to be 2.6084 mg/l for Pseudomonas putida.