Registration Dossier
Registration Dossier
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EC number: 915-568-3 | CAS number: -
Ecotoxicological Summary
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:
- 100 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
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
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no exposure of soil expected
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 70 mg/kg food
- Assessment factor:
- 90
Additional information
Dresinate 832A / 835 A is not bioaccumulative (BCF <130); nevertheless a PNEC oral has been calculated.
The 90-Day Oral Toxicity Study with Rats is the available oral toxicity studies for mammals.
NOAEL = 316 mg / (kg bw * day)
Equation R.10-7 of the “Guidance on information requirements and chemical safety assessment” is used:
NOECmammal (mg/kg food) = NOAELmammal,oral (mg/kg bw per day) * CONVmammal (kg bw * day / kg food)
Test animals used: rat, strain: Fischer F344/DuCrl, SPF, age at study initation: about 7 weeks. Therefore the conversion factor CONVmammal forRattus norvegicus(> 6 weeks) of 20 kg bw * day / kg food is used.
NOECmammal = 6320 mg/kg food
AForal: an assessment factor of 90 was chosen (90 day study, mammal) according to ECHA document: “Guidance on information requirements and chemical safety assessment” Table R.10-13.
PNECoral = NOECmammal / AForal = 70 mg/kg food = 70 ppm.
Conclusion on classification
The lowest short term aquatic EC/EL50 value of Dresinate 832A / 835A was determined in the Daphnia tudy with an 1.6 mg/L. As Dresinate 832A/835A is readily biodegradable, using the criteria in GHS and DSD there is no need for environmental classification.
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