Registration Dossier
Registration Dossier
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EC number: 228-958-7 | CAS number: 6379-72-2
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 13.3 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.133 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 1.33 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:
- 0.422 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.042 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:
- 0.077 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 8.8 mg/kg food
- Assessment factor:
- 300
Additional information
Aquatic toxicity (including STP)
One experimental study of reliability 4 (based on international guideline and GLP compliance) and two reliable QSAR models were used to assess the aquatic toxicity of the registered substance, (E)-1,2 -Dimethoxy-4 -prop-1 -en-1 -ylbenzene, to fish, aquatic invertebrates and algae.
In the experimental study on aquatic invertebrates Daphnia magna (NOACK, 2000), performed on the registered substance, the 48-EC50 value was determined at 25 mg/L (95% CL: 23 - 27 mg/L), based on nominal concentrations. The test substance was analytically verified only at the beginning of the test, using DOC analysis. No analytical verification of test concentrations was performed at the end of the test. The initial measured concentration at the nominal concentration of 25 mg/L was 16.26 mg/L. As some loss of test substance may be expected during the duration of the test, the mean measured 48h-EC50 value may be expected to be less than 16.26 mg/L. This result is completely in line with the QSAR results on aquatic invertebrates performed on the registered substance which are both very close to the measured value from the daphnid study.
The two QSAR models used were iSafeRat holistic approach v1.4 and ECOSAR v1.11 models. Both QSAR results, performed on the registered substance, were considered reliable as the substance falls within the applicability domain of the models. The E(L)C50 key values, used for chemical safety assessment, were determined as the geometric mean of predicted E(L)C50 values and, when available, measured value (for aquatic invertebrates), corresponding to 16.5 mg/L for fish, 14.4 mg/L for aquatic invertebrates and 13.3 mg/L for algae.
Finally, the registered substance is readily biodegradable and no inhibition effects of the activity of microorganisms was observed in the biodegradation study at 100 mg/L. Therefore, in accordance with column 2 of REACH Annex VIII, the activated sludge respiration inhibition test does not need to be conducted.
Sediment, terrestrial toxicity and hazard for predators
In the absence of any ecotoxicological data for sediment-dwelling/soil organisms, the PNEC sediment/soil were calculated using the equilibrium partitioning method (EPM).
Furthermore, no toxicity studies reporting the secondary poisoning effects on birds were available, therefore the 28-day repeated dose toxicity study performed on the registered substance was used to derive the PNECoral.
Environmental fate and pathways
The registered substance is readily biodegradable (total biodegradation after 28 days) and therefore is not persistent in the environment. In addition, the registered substance is considered to have a low potential for adsorption based on the low octanol water partition coefficient (log Kow = 2.9).
Conclusion on classification
No harmonised classification is available on the registered substance.
10 < lowest E(L)C50 value < 100 mg/L; readily biodegradable; log Kow lower than 4.0 (= 2.9).
Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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