Registration Dossier
Registration Dossier
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EC number: 262-979-2 | CAS number: 61788-48-5
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
If tested some enzymatic catalyzed hydrolysis would occur during biodegradation testing of lanolin acetate, but it will be part of the overall biodegradation process. Poor solubility would likely be the limiting factor in this test.
Read across to Fatty acids, lanolin results: 71% degradation after 28 days, but failing 10-day window, overall readily biodegradable.
Read across to lanolin alcohol results: 39% degradation in 28d and therefore cannot be considered to be readily biodegradable.
No information is available for bioaccumulation to draw a conclusion.
Lanolin acetate will most likely not hydrolyze in the fish toxicity test. However, the molecule is insoluble. Any toxicity (other than gill fowling at high doses) would come from the component fatty acids and alcohols which are more soluble and bioavailable.
Read across to Fatty acids, lanolin results: Oncorhynchus mykiss LL50(96h) > 100 mg/L; NOELR(96h) = 100 mg/L.
Read across to lanolin alcohol results: Danio rerio LC50(96h) > 100 mg/L; NOEC(96h) > 100 mg/L.
Lanolin acetate will most likely not hydrolyze in the fish/ invertebrate toxicity test. However, the molecule is insoluble. Any toxicity (other than gill fowling at high doses) would come from the component fatty acids and alcohols which are more soluble and bioavailable.
Read across to Fatty acids, lanolin results: Daphnia magna EL50(48h) > 100 mg/L; NOELR(48h) = 100 mg/L.
Read across to lanolin alcohol results: Daphnia magna limit concentration (0.13 mg DOC/L) no biologically significant effects were determined.
Lanolin acetate will most likely not hydrolyze in the algal toxicity test. However, the molecule is insoluble. Any toxicity would come from the component fatty acids and alcohols which are more soluble and bioavailable.
Read across to Fatty acids, lanolin results: Desmodesmus subspicatus EL50(72h) > 100 mg/L; NOEC(72h) = 100 mg/L.
Read across to lanolin alcohol results: Desmodesmus subspicatus NOEC(72h) = 0.15 mg/L; EC50(72h) > 2.5 mg/L.
Only acute oral testing data available for the Lanolin, acetate. 5 groups containing 1 male & 1 female rat, gavage - LD50 > 10 mL/kg; doses of 2.5 to 40.0 mg/kg, resulted in no fatalities.
No evidence of toxicity in mammalian test as summarized below in read across data:
Read across to Fatty acids, lanolin results: Acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Read across to Alcohols, lanolin results: The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Read across to Fatty acids, lanolin results: There were no adverse clinical signs of toxicity detected in 90 day repeat (oral) dose testing, which resulted in a NOAEL of ≥ 1000 mg/kg bw/day (highest dose tested).
Read across to Alcohols, lanolin results: There were no adverse clinical signs of toxicity detected in 90 day repeat (oral) dose testing, which resulted in a NOAEL of ≥ 1000 mg/kg bw/day (highest dose tested).
Reference
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