Registration Dossier

Ecotoxicological information

Sediment toxicity

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Administrative data

Endpoint:
sediment toxicity: long-term
Type of information:
experimental study planned
Study period:
The study will be conducted following acceptance of this testing proposal
Justification for type of information:
TESTING PROPOSAL FOR ANNEX X ENDPOINT

NON-CONFIDENTIAL NAME OF SUBSTANCE:

- Name of the substance on which testing is proposed to be carried out: Rosin (CAS 8050-09-7)
- Name of the substance for which the testing proposal will be used: Rosin (CAS 8050-09-7); Hydrogenated rosin (CAS 65997-06-0); Resin acids and Rosin acids, potassium salts (CAS 61790-50-9); Resin acids and Rosin acids, sodium salts (CAS 61790-51-0); Resin acids and rosin acids, magnesium salts ((CAS 68440-56-2);Resin acids and rosin acids, calcium salts (CAS 9007-13-0); Resin acids and rosin acids, calcium zinc salts (CAS68334-35-0); Rosin, reaction products with formaldehyde (CAS 91081-53-7)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:

- Available GLP studies: There are no available GLP studies for long-term sediment toxicity for any member of the category.
- Available non-GLP studies: There are no available non-GLP studies for long-term sediment toxicity.
- Historical human data: Human data is not relevant for long-term sediment toxicity.
- (Q)SAR: No validated (Q)SAR models are available for long-term sediment toxicity.
- In vitro methods: No in vitro methods are available for long-term sediment toxicity.
- Weight of evidence: There is not enough data for long-term sediment toxicity to conduct a weight-of-evidence assessment.
- Grouping and read-across: A read-across approach has been used to fulfil several endpoints for substances in the category rosin and rosin salts. No data are available for long-term sediment toxicity for any substance in this category. One long-term sediment test with Rosin (CAS 8050-09-7) is proposed to fill the data gap for the substance itself. It is proposed that this study will be read-across to fill the long-term sediment toxicity data gap for other substances in this category.
- Substance-tailored exposure driven testing [if applicable]: No environmental classifications apply to this substance based on available data for category members and consequently no chemical safety assessment is required on the basis of classification. Rosin is readily biodegradable, therefore it is expected to degrade rapidly in the environment and not be toxic to sediment organisms. This conclusion was presented as a waiver in the registration dossiers for all substances included in this testing proposal, however the waiver was rejected by ECHA during the manual screening process. Testing is therefore proposed for Rosin to complete this endpoint, and the result will be read across to other members of the rosin and rosin salts category.
- Approaches in addition to above [if applicable]: None
- Other reasons [if applicable]: None

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:

- A waiver was submitted for long-term sediment toxicity on the basis that the substances in the category rosin and rosin salts are readily biodegradable. A chemical safety assessment is not required for these substances, as the available data did not indicate environmental classification is required. The waiver was rejected by ECHA during the manual screening process. No other adaptation possibilities are available and therefore testing is proposed for one category member to generate the necessary information for long-term sediment toxicity, which is required information for Annex X substances.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:

- Details on study design / methodology proposed: OECD Guideline 218 (Sediment-Water Chironomid Toxicity using Spiked Sediment) is proposed with the test substance Rosin (CAS 8050-09-7). The test is a standard guideline toxicity test suitable to fill the data gap for long-term sediment toxicity as required under Annex X of REACH. The result will be read across to other members of the category rosin and rosin salts.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion