Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.6 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
16 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.16 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.77 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.18 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.35 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
146 mg/kg food
Assessment factor:
90

Additional information

Environmental fate and pathways:

The registered substance was found to undergo hydrolysis at pH 7 and 9 only, with estimated half-lives (at 25°C) of 994 hours and 18.1 hours respectively (EU Method C.7). Based on the key biodegradation study (OECD Guideline 301D), the registered substance is considered to be readily biodegradable. The bioconcentration factor (BCF) of the C6 and C7 isomers of the registered substance were estimated with a QSAR model (BCFBAF model v3.01 from EPI Suite v4.1, using experimental log Kow value at 4.46) at 215 L/kg whole body weight and 222 L/kg whole body weight, respectively. Finally, the adsorption coefficient (log Koc) of the registered substance was determined to be 4.0 (OECD Guideline 121 and EU Method C.19). This result indicates that the registered substance is immobile in soil (according to P.J. McCall et al., 1980).

Aquatic toxicity:

Acute data of variable reliabilities, based on international guidelines, are available for three trophic levels: Algae, Invertebrates and Fish.

Among all data available, the fish Oncorhynchus mykiss seems to be the most sensitive species with a 96h-LC50 at 1.6 mg/L. No toxicity was observed on the algae Scenedesmus subspicatus and on the aquatic invertebrates Daphnia magna up to the highest attainable concentration, measured at 3.73 mg/L for algae test and 3.16 mg/L for daphnia study. No toxicity was observed on micro-organisms of a water treatment plant up to 100 mg/L (nominal concentration).

Care must be taken from CIT studies (algae, aquatic invertebrates and fish studies). The analytical methodology of these studies is not adapted and is insufficient to measure with precision the concentrations tested. No submission of other studies was proposed because one valid study is available to assess the acute toxicity of the most sensitive species: fish.

In accordance with column 2 of REACH annex IX, further testing on the long-term effects on aquatic organisms does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.

Terrestrial toxicity:

According to section R.7.11.5.3., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (version 3.0, June 2017), the registered substance should be classed as a soil hazard category 1 (log Kow < 5; EC/LC50 > 1 mg/L for algae, daphnia and fish). Therefore, the Equilibrium Partitioning Method (EPM) has been used as a screening assessment, for assessing the hazard to terrestrial organisms. As RCR soil < 1, no toxicity testing for soil organisms need to be done. Terrestrial toxicity studies are scientifically unjustified.

Conclusion on classification

The most sensitive group is the fish (LC50(96h)= 1.6 mg/L, i.e. between 1-10 mg/L), the substance is readily biodegradable and have an estimated BCF at 215 L/kg and 222 L/kg for C6 and C7 isomers, respectively (lower than 500).

Therefore, based on Regulation (EC) No 1272/2008 (CLP) criteria, the registered substance is NOT classified for the environment.