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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study planned (based on read-across)
Study period:
The study will be conducted following acceptance of this testing proposal
Justification for type of information:
TEST PROPOSAL FOR ANNEX IX ENDPOINT
The long-term testing on terrestrial macro-organisms except arthropods study is proposed to be conducted according to OECD TG 222 (2016). This test proposal is submitted as a data-gap for this endpoint has been identified by the H4R Consortium.

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 [if different from tested substance]: The testing proposal will be used for other substances in the category:
1) Rosin, hydrogenated (CAS 65997-06-0)
2) Rosin, oligomers (CAS 65997-05-9)
3) Resin acids and Rosin acids, sodium salts (CAS 61790-51-0)
4) Resin acids and Rosin acids, potassium salts (CAS 61790-50-9)
5) Resin acids and Rosin acids, magnesium salts (CAS 68440-56-2)
6) Resin acids and Rosin acids, calcium salts (CAS 9007-13-0)
7) Resin acids and Rosin acids, calcium zinc salts(CAS 68334-35-0)
8) Resin acids and Rosin acids, aluminum salts (61789-65-9)
9) Resin acids and Rosin acids, manganese salts (CAS 9008-34-8)
10) Resin acids and Rosin acids, dimers, calcium zinc salts (CAS 1192825-55-0)
11) Resin acids and Rosin acids, hydrogenated, calcium salts (CAS 68554-12-1)
12) Resin acids and Rosin acids, hydrogenated, sodium salts (CAS 68990-02-3)
13) Rosin, reaction products with formaldehyde (CAS 91081-53-7)
14) Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt (CAS 92129-53-8)
15) Resin acids and Rosin acids, reactions with formaldehyde, sodium salts (CAS 91081-28-6).

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: There are no available GLP studies for long-term toxicity in terrestrial organisms.

- Available non-GLP studies: There are no relevant studies available for long-term toxicity in terrestrial organisms.

- Historical human data: Not applicable to long-term toxicity testing in terrestrial organisms.

- (Q)SAR: The category members are UVCBs, and as QSAR predictions would be only derived for single constituents, QSAR would not be appropriate to assess hazard to the terrestrial environment of poorly water-soluble UVCBs. In addition, the available validated ECOSAR model does not contain earthworm data for the class ‘Rosin’.

- In vitro methods: Currently, there are no validated EU / OECD guidelines for in vitro tests that would be relevant to terrestrial toxicity.

- Weight of evidence: Since there are no reliable data on long-term toxicity studies in terrestrial species (experimental, QSAR or, based on read across), it is not possible to derive a weight of evidence for this endpoint.

- 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 terrestrial toxicity for any substance in this category.

- Substance-tailored exposure driven testing [if applicable]: NA

- Approaches in addition to above [if applicable]: NA

- Other reasons [if applicable]: The results from long-term terrestrial testing would improve the existing data-set for category.

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:
No adaptations are applicable from Column 2 of Annexes VI to X as direct and indirect exposure to soil is not avoided, in addition the substances have high log Koc values, indicating high adsorptive potential to soil.

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 Earthworm Reproduction Test (Eisenia fetida/ Eisenia andrei) will be conducted according to OECD TG 222 (2016). Details on the definitive test design will be determined during the pre-tests and in the study plan phase with the consortium and the Study Director.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance name: Rosin

Test organisms

Test organisms (species):
other: Eisenia fetida / Eisenia andrei

Results and discussion

Applicant's summary and conclusion