Registration Dossier
Registration Dossier
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EC number: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- N,N-bis(2-hydroxypropyl)benzamide
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- N,N-bis(2-hydroxypropyl)benzamide
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Assessment of P properties
Substance was not readily biodegradable in a valid screening test after 28 days, but it showed biodegradation higher than 70% after 45 days.
Half-life time of the substance in water at 25 °C was determined to be, in a guideline hydrolysis study with different pH values, in the range from 253 days (pH 9) to 514 days (pH 7).
Substance was considered to be P not vP.
Assessment of B properties
Log Kow was found to be 0.23 in a guideline study with validation criteria fulfilled.
Substance was considered not B and not vB based on screening criteria for LogKow < 4.5
Assessment of T properties
EC10 on freshwater algae was determined to be 89 mg/L in a guideline study after 72 hours , which can be considered a long-term result.
Acute toxicity results showed LC50 > 100 mg/L for all three trophic levels.
No effects observed in three different guideline studies on genetic toxicity.
Carcinogenity has not been evaluated, since not required at this tonnage band.
No effects on reproduction were estimated in a QSAR qualitative prediction from a valid model.
No adverse effects observed in a valid subacute study on repeated dose toxicity (28d - oral - rats) according to international guidelines.
Therefore substance was considered not T.
Reference
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