Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Dipropylene glycol dibenzoate
- Name of the substance for which the testing proposal will be used [if different from tested substance] : same

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies : Acute toxicity studies are available for fish, daphnids and algae but no longer term endpoints to access sublethal effects are available.
- Available non-GLP studies : none
- Historical human data : Human endpoints are not useful in predicting long-term environmental risk.
- (Q)SAR: Although acute estimates were somewhat predicted of acute experimental endpoints, the solbuility of the test material causes some issues with long-term testing predictions.
- In vitro methods: In vitro methods are not useful in predicting long-term environmental risk.
- Weight of evidence: : No chronic data are available to use in a weight of evidence approach.
- Grouping and read-across: : This approach is not reliable in evaluation of environmental risk as no appropriate analogues were available.
- - Substance-tailored exposure driven testing [if applicable] : no
- Approaches in addition to above [if applicable] : none
- Other reasons [if applicable]

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Due to the use of this substance in agricultural chemical formulations, long-term testing is requested to allow for the evaluation and identification of any potential environemntal hazard.



FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: The study design for a Daphnia magna reproduction study would follow OECD 211.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dipropylene glycol dibenzoate (DPGDB)
- Physical state: Clear colourless liquid
- Analytical purity: Not stated
- Lot/batch No.: 9903-28-1
- Expiration date of the lot/batch: 29 July 2000
- Storage condition of test material: Room temperature.

Results and discussion

Applicant's summary and conclusion