[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

An OECD test guideline 210, Fish early stage toxicity Study is proposed as per REACH Annex IX, Section 9.1.6. The test period will be established once the ECHA approves this Test Plan.

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

- A testing proposal is included in the dossier to conduct an experimental Fish reproduction test, according to OECD Guideline 210, on the registered substance. The test on Fish is proposed, since according to the outcome of iSafeRat QSAR model, fish is the most sensitive species in chronic exposure. An experimentally- determined EC10 value would allow to conclude appropriately on the environmental classification of the registered substance. After acceptance of the submitted testing proposal for a Fish reproduction test, by ECHA, and when the new experimental study report is made available, the dossier and the final environmental classification will be updated.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : (-)-(3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan


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: no data available
- Available non-GLP studies : no data available
- Historical human/control data : no data available
- (Q)SAR : QSAR data on Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan is available. However the QSAR result is very low compared to results of the other studies. An experimentally- determined EC10 value would allow to conclude appropriately on the environmental classification of the registered substance
- In vitro methods : no data available
- Weight of evidence : no data available
- Grouping and read-across : QSAR data on Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan is available. However the QSAR

In conclusion, there is no reliable Long term toxicity to fish study (OECD 210) for (-)-(3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan available on the existing data to cover the endpoint long term toxicity to fish.



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:

Section 9.1.6 of Annex IX of REACH 9.1.6. Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements). The information shall be provided for one of the Sections 9.1.6.1, Fish early-life stage (FELS) toxicity test , 9.1.6.2 Fish short-term toxicity test on embryo and sac-fry stages or 9.1.6.3. Fish, juvenile growth test. No specific rules according to column 2.

In consequence, a Fish early-life stage (FELS) toxicity test (OECD guideline 210) is proposed.


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed : Flow-through or semi static condition
Nominal concentration : saturated solution at 10 mg/L

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Test material

Test material information

Constituent 1

Reference substance name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

EC Number:

229-861-2

EC Name:

[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan

Cas Number:

6790-58-5

Molecular formula:

C16H28O

IUPAC Name:

(3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyl-dodecahydronaphtho[2,1-b]furan

Test material form:

solid

Details on test material:

- Substance type: white solid
- Physical state: solid
- Storage condition of test material: at room temperature
- Other: water solubility = poorly soluble in water