Resin acids and Rosin acids, sodium salts

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

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 IX AND X INFORMATION REQUIREMENTS
The proposed OECD 210 Fish Early Life Stage study to fill Long-Term Toxicity to Fish will only be conducted if the OECD 211 study data and the lower annex studies that will be commissioned show that Annex XI waivers cannot be utilised. It is accepted that some tests on fish may be required but the number and type of substances that is appropriate to test will not be clarified until the rest of the data is received and appraised.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
o Unknown until data from OECD 211 and lower annex studies is available.
- Name of the substance for which the testing proposal will be used [if different from tested substance]
- Rosin CAS No: 8050-09-7
- Rosin, hydrogenated CAS No: 65997-06-0
- Rosin, oligomers CAS No: 65997-05-9
- Resin acids and rosin acids, sodium salts CAS No: 61790-51-0
- Resin acids and rosin acids, potassium salts CAS No: 61790-50-9
- Resin acids and rosin acids, calcium salts CAS No: 9007-13-0
- Resin acids and rosin acids, magnesium salts CAS No: 68440-56-2
- Resin acids and rosin acids, calcium zinc salts CAS No: 68334-35-0
- Rosin, reaction products with formaldehyde CAS No: 91081-53-7
- Resin acids and rosin acids, reaction products with formaldehyde, sodium salts CAS No: 91081-28-6
- Resin acids and rosin acids, reaction products with formaldehyde, potassium salt CAS No: 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 Invertebrates.
- Available non-GLP studies: There are no available studies for long-term toxicity in aquatic invertebrates.
- Historical human data: Not applicable to long-term toxicity testing in aquatic invertebrates.
- (Q)SAR: The category members are UVCBs, therefore, QSAR predictions would be only derived for single constituents. It would not be appropriate to assess hazard to the aquatic environment of poorly water-soluble UVCBs using QSARs.
- In vitro methods: Currently, there are no EU / OECD guidelines for in vitro tests of relevance 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 toxicity in daphnia 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. The general chemistry of the substances in this category is very similar but there are also some significant differences such as the presence of inorganic salts, formaldehyde and dimerised rosins. It is important to ensure that these differences are characterised and that the data density is high enough to establish that all of the potential environmental hazards have been identified and that risk assessments are protective of all organisms. In order to target testing within this category to meet this objective, the category has been split into sub-categories. This way, it can be ensured that there is enough data in each subcategory to fully characterise the category as a whole. These sub-categories may, in some cases, be different for environmental and mammalian toxicity endpoints. Higher Annex Ecotoxicity studies have been proposed for at least 1 member of each of these categories if Higher Annex studies are required (i.e., it contains substances registered for at least Annex IX 100-100 TPA).
Category 1 is divided into the following sub-categories:
• Rosin and hydrogenated rosin
• Dimerised rosin
• Monovalent salts
• Divalent salts
• Trivalent salts (only contains an Annex VII substance)
• Reaction products with formaldehyde
The consortium has also committed to filling data gaps for lower annex studies to provide a full set of data to support the read-across approach for the higher annex studies. This is detailed in the attached testing strategy.
- Substance-tailored exposure driven testing [if applicable]
The OECD 211 studies proposed and the additional lower annex studies to fill the data gaps are intended to provide enough data to be able to provide robust exposure assessments. These will be used to determine if long-term toxicity to fish testing is required or if the hazard and risk assessment can be completed without the use of vertebrate animals. If further data on the long-term toxicity to fish is still required then this data gap will be filled. However, at this point without the lower annex data or the data on long-term testing in invertebrates it is not clear how many (if any) fish tests will be required or which substances would be most appropriate to test.
- Approaches in addition to above [if applicable]: Not applicable
- Other reasons [if applicable]: The results from long-term aquatic testing would improve 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:
Following the Board of Appeal Decision Column 2 can no longer be used to waive the data requirements for long-term testing in invertebrates.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, oligomers

EC Number:

500-163-2

EC Name:

Rosin, oligomers

Cas Number:

65997-05-9

Molecular formula:

C40H120O4

IUPAC Name:

Rosin oligomers

Constituent 2

Reference substance name:

Resin acids and Rosin acids, sodium salts

EC Number:

263-144-5

EC Name:

Resin acids and Rosin acids, sodium salts

Cas Number:

61790-51-0

Molecular formula:

C19H29COOH

IUPAC Name:

Resin acids and Rosin acids, sodium salts

Constituent 3

Reference substance name:

Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts

EC Number:

293-631-8

EC Name:

Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts

Cas Number:

91081-28-6

IUPAC Name:

Resin acids and Rosin acids, reaction products with formaldehyde, sodium salt

Constituent 4

Reference substance name:

Rosin

EC Number:

232-475-7

EC Name:

Rosin

Cas Number:

8050-09-7

Molecular formula:

Unspecified.

IUPAC Name:

Rosin

Constituent 5

Reference substance name:

Resin acids and Rosin acids, magnesium salts

EC Number:

270-461-2

EC Name:

Resin acids and Rosin acids, magnesium salts

Cas Number:

68440-56-2

Molecular formula:

C40H58MgO4

IUPAC Name:

magnesium (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-propan-2-yl-2,3,4,4b,5,6,10,10a-octahydrophenanthrene-1-carboxylate

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)