Registration Dossier
Registration Dossier
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EC number: 232-430-1 | CAS number: 8027-33-6 A complex combination of organic alcohols obtained by the hydrolysis of lanolin.
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
Biodegradation above 20% of theoretical (measured as BOD, DOC removal or COD) may be regarded as evidence of inherent, primary biodegradability, whereas biodegradation above 70% of theoretical (measured as BOD, DOC removal or COD) may be regarded as evidence of inherent, ultimate biodegradability. Considering the stringent testing conditions of an OECD 301 test design, the 39% biodegradation as observed for Lanolin alcohols are regarded as sufficient to state that the substance is not persistent. This assumption is supported by the expected metabolic integration / transformation of the test substance.
Bioaccumulation:
Available data indicate that the substance is not bioaccumulative in a classical sense due to its active metabolic regulation. A
dietary study for Cholesterol, the main component of Lanolin alcohols, is currently beeing is assessed. The results will be integrated in an update dossier as soon as the assessment is finalised. For further information please see technical dossier chapter 5.3.1.Toxicity:
According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. Data for long term toxicity on algae and fish are available showing no effects up to the limit of water solubility. Long term toxicity data on Daphnia magna is available showing no effects at 100 mg/L nominal loading rate. Therefore the test substance is not considered as a toxic substance regarding ecotoxicological endpoints.
The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any other evidence for chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). The criteria for âTâ based on mammalian effects are therefore not met.
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