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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
52.6 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.259 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
5.26 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
25.9 µg/L

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
16.4 µg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Additional information

The substance is a transported isolated intermediate, which is used under strictly controlled conditions in the manufacture of another substance. Release of substance to the environment is controlled by appropriate technical and managerial means. Environmental exposure to the substance is thus minimised. A derivation of PNECs is deemed not necessary.

 

 

Conclusion on classification

Adequate chronic and acute toxicity data are available for all three trophic levels.

For long-term toxicity to fish in freshwater, the most sensitive endpoint for Pimephales promelas was determined to be hatching success, with a 4-day EC10 of 6.2 mg/L. For long-term toxicity to aquatic invertebrates in freshwater, a 21-day reproduction test with Daphnia magna was used to determine the most sensitive endpoint which was the total living offspring produced per parent animal, with a NOEC of 0.526 mg/L. For long-term toxicity to aquatic algae and cyanobacteria, the impact of the test item on the growth of the freshwater green algal species (Pseudokirchneriella subcapitata) was determined by a 72-h NOEC of 1.5 mg/L.

For the short-term toxicity data fish, the 96-hour LC50 for Danio rerio exposed to the test item was determined to be 25.87 mg/L (95 % confidence limits: 23.89 - 28.01 mg/L). For short-term toxicity to aquatic invertebrates, the 48-h EC50 of the test item to Daphnia magna was determined to be 26 mg/L. For short-term toxicity to aquatic algae and cyanobacteria, the impact of the test item on the growth of the freshwater green algal species (Pseudokirchneriella subcapitata) was determined by a 72-h EC50 > 66 mg/L. 

Further, the test item was determined to be not readily biodegradable, based on the CO2 Evolution (Modified Sturm) test which resulted in < 5 % degradation of CO2 and Biochemical Oxygen Demand test which resulted in ca. 22.3 % degradation (O2 consumption).

 

Acute classification is based on the reliable acute toxicity endpoints. Since no acute toxicity effect value is < 1 mg/L, the data are conclusive but not sufficient for classification. Thus, no classification for acute aquatic toxicity is triggered for the test item according to Regulation (EC) No. 1272/2008, as amended by Regulation (EC) No. 286/2011.

Chronic classification is based on the reliable long-term toxicity endpoints that are available and the result of the biodegradation study. Since at least one long-term effect value is < 1 mg/l and > 0.1 mg/L (21-d NOEC = 0.526 mg/L, daphnia manga) and the substance being not readily biodegradable, the substance needs to be classified as Aquatic Chronic 2. The substance thus meets the criteria for classification as Hazardous to the aquatic environment, Category Chronic 2, according to Regulation (EC) No. 1272/2008, as amended by Regulation (EC) No. 286/2011.