Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
54.2 µg/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:
110 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

The PNECaqua values were determined for the substance itself by application of methods provided in ECHA Guidance Chapter R.10 (May 2008).

The PNEC sediment, soil and oral were determined by using the data available on alpha pinene, one of the main constituent of the substance, as worst case.

Conclusion on classification

The substance is an organic UVCB substance mainly composed of terpene hydrocarbons that are slightly soluble in water and stable to hydrolysis.

The short-term toxicity of the substance to aquatic organisms was investigated according to OECD guidelines and compliant with GLP. The following toxicity values are available for the substance:

Fish Acute: 96h-LC50 = 5.1 mg/L

Aquatic invertebrates: 48h-EC50 = 2.1 mg/L

Algae: 72h-ErC50 = 4.8 mg/L

The lowest acute aquatic toxicity values based on available data ranges between 1 and 10 mg/L. The long-term toxicity of the substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

The degradation of the substance was investigated according to OECD Guideline 301D. Two reliable study carried out with different batches are available for the substance. Under the test conditions, the substance was found to be readily biodegradable (81% and 83% biodegradation after 28 days). Therefore, the substance is considered as rapidly degradable in aquatic system.

Information on bioaccumulation potential of the submission substance: No fish BCF is available. Log Kow range between 3.97 and 4.46 for the main constituents of the substance which indicates a potential for bioaccumulation.

CLP Classification proposal

Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.

Chronic aquatic hazard: Category 2, H411. Reasoning: lowest acute E(L)C50 value range between 1 and 10 mg/L, readily biodegradable substance with Log Kow > 4. The determination of M-Factor is not applicable.

DSD Classification proposal

N; R51/53. Reasoning: lowest acute E(L)C50 value range between 1 and 10 mg/L, readily biodegradable substance with Log Kow > 3.