Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Justification for Read-across:

Please refer to the justification document attached to section 13.

Environmental fate and pathways:

The registered substance, (-)-(3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan, contains no organic functional groups that may hydrolyse under environmental condition like alkyl halides, amides, amines, epoxides, esters. This substance consists only of organic functional groups that are relatively or completely inert with respect of hydrolysis. Based on the chemical structure an estimation of the hydrolysis rate is not possible. This statement is supported by one study showing that the registered substance is hydrolytically stable under the conditions of the test (the disappearance of the substance after 5 days as well as after 28 days is less than 10% at any pH (from 2 to 12) at 40°C).

Based on the key biodegradation study, the registered substance is readily biodegradable and therefore is not considered persistent in the environment. Finally, based on data on a source substance (which is the racemic form of the registered substance), (±)-(3aR*,5aS*,9aS*,9bR*)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan , the adsorption coefficient (Koc) of the registered substance can be determined at 5250, corresponding to a log Koc at 3.72. The result indicates that the registered substance is environmentally immobile in soils, according to P.J. McCall et al., 1980. Based on structural similarity and common physico-chemical properties between these isomers, this source substance is considered adequate for read-across purposes (see IUCLID section 13 for justification).

Aquatic toxicity:

The aquatic toxicity of the registered substance, was assessed using data performed on the registered substance and on source substance (stated above). Based on structural similarity and common physico-chemical properties between these isomers, and the same results on the observed toxicity to aquatic invertebrates (no acute effect up to the attainable limit of solubility in test medium, see ECHA disseminated dossier of the read-across substance EC# 223 -118 -6), this source substance is considered adequate for read-across purposes.

No toxic effects were observed up to the attainable limit of solubility of the registered and/or supporting substances in acute studies for the three aquatic trophic levels (fish, aquatic invertebrates and algae) and no long-term effect was observed in the algae study at the maximum attainable mean test concentration. Therefore, based on a read-across approach, the registered substance is not expected to be hazardous to pelagic organisms. The chemical safety assessment for environment is not necessary.

In accordance with column 2 of REACH Annex VIII, the activated sludge respiration inhibition test does not need to be conducted because the substance is readily biodegradable, according to the OECD 301F study. The applied test concentrations (100 mg/L) are in the range of concentrations that can be expected in the influent of a sewage treatment plant, and no inhibition effects on the activity of microorganisms was observed.This statement is supported by one study, performed on the registered substance, according to DIN Guideline 38412 part 27 with GLP statement. The test substance had no inhibitory effect on the respiration rate of Pseudomonas putida after the incubation period of 30 min at the test item concentration of 10 g/L.

Conclusion on classification

No acute toxic effects were observed on all trophic levels at or even close to the water solubility of the substance and no chronic effect was observed in the algae study at the maximum attainable mean test concentration.

The substance is readily biodegradable meeting the 10-day window criterion.

Classification according to the Annex I of the Regulation (EC) No 1272/2008 (CLP): The substance is NOT classified for the environment.