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Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Endpoint:
fish early-life stage toxicity
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:
A discussion and report on the read across strategy is given as an attachment in Section 13.
A data matrix of the category is attached below.


TESTING PROPOSAL ON VERTEBRATE ANIMALS
TEST PROPOSAL FOR ANNEX IX ENDPOINT
The long-term testing on fish testing study is proposed to be conducted in combination with the long-term testing on aquatic invertebrates. A two-tier approach is submitted, starting with long-term testing on daphnia and followed by fish testing, to minimise vertebrate testing where and when possible according to the ECHA guidance document R7b (2017).
This test proposal is submitted as a response to the ECHA manual completeness check letter concerning sections 6.1.2 Long-term toxicity to fish and 6.1.4 Long-term toxicity to aquatic invertebrates for three of the substances in the rosins and rosin salts category. Three substances from this category will be tested to reflect the range of rosins/rosin salts within the category to allow for a robust read across.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
Rosin Oligomers, CAS 65997-05-9, EC 500-163-2
Resin acids rosin acids, sodium salts, CAS 61790-51-0, EC 263-144-5
Resin acids rosin acids, reaction products with formaldehyde, sodium salts, CAS 91081-28-6, EC 293-631-8

- Name of the substance for which the testing proposal will be used [if different from tested substance]
1) Rosin (CAS 8050-09-7)
2) Rosin, hydrogenated (CAS 65997-06-0)
3) Resin acids and Rosin acids, potassium salts (CAS 61790-50-9)
4) Resin acids and Rosin acids, magnesium salts (CAS 68440-56-2)
5) Resin acids and Rosin acids, calcium salts (CAS 9007-13-0)
6) Resin acids and Rosin acids, calcium zinc salts (CAS 68334-35-0)
7) Resin acids and Rosin acids, aluminum salts (CAS 61789-65-9)
8) Resin acids and Rosin acids, manganese salts (CAS 9008-34-8)
9) Resin acids and Rosin acids, dimers, calcium zinc salts (CAS 1192825-55-0)
10) Resin acids and Rosin acids, hydrogenated, calcium salts (CAS 68554-12-1)
11) Resin acids and Rosin acids, hydrogenated, sodium salts (CAS 68990-02-3)
12) Rosin, reaction products with formaldehyde (CAS 91081-53-7)
13) Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt (CAS 92129-53-8).

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 aquatic organisms.

- Available non-GLP studies
There are no relevant studies available for long-term toxicity in fish. However, a 20-day fish bioaccumulation study was conducted by Niimi and Lee (1992), that exposed adult rainbow trout to nine resin acids (abietic, dehydroabietic, chlorodehydroabietic, dichlorodehydroabietic, neoabietic, pimaric, isopimaric, sandaracopimaric, and palustric acids), to water borne concentrations of 0.7 – 3.6 µg/L for 20 days. The study concluded no mortalities were observed at these concentrations. This study however, does not satisfy the criteria to fill the end-point for long-term toxicity in fish or, as part of a weight of evidence approach for the same endpoint.

- Historical human data
Not applicable to long-term toxicity testing on fish.

- (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 aquatic environment of poorly water-soluble UVCBs. In addition, the available validated QSAR models do not provide information on the life stage of the fish the values are applicable for.

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

- Weight of evidence
Since there are no reliable data on long-term toxicity studies (experimental, QSAR or, based on read across) for long-term in fish or other aquatic species, 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 aquatic toxicity for any substance in this category. Three long-term fish tests are proposed, using the three representative category members to fill the data-gaps for these substances, and to then be used to read-across to other substances in the 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 aquatic testing would improve the clarity of the 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:
The substances are poorly water-soluble, therefore, no adaptations are applicable from Column 2 of Annexes VI to X.

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 FELS test will be carried out using the zebrafish (Danio rerio) according to OECD TG 210 (2013). In addition, the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD Series on Testing and Assessment, No. 23 will be considered as the proposed test materials are UVCB substances. Details on the definitive test design will be determined during the pre-tests and following the Daphnia magna reproduction test.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion