Registration Dossier
Registration Dossier
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EC number: 946-364-2 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Reference substance:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Criteria for assessing PBT properties are defined in Annex XIII, REACH Regulation (EC) No 1907/2006. Further details are laid down in ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT Assessment (Nov 2014). The assessment of PBT / vPvB properties is based upon a separate assessment for each parameter (i.e. P or vP, B or B and T). Substances are only assigned as PBT or vPvB when they fulfil the criteria for all three properties (persistency, bioaccumulation and toxicity in case of PBT substance) or both criteria (i.e. very persistent and very bioaccumulative) in case of vPvB, respectively.
Due to results of ready-biodegradability tests, the test item is considered as not persistent (not P) and not very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfilled, due to the determined logPow of 6.79 and the rapid biodegradation of 94 % in 28 days, although the predicted Bioconcentration factor (BCF) is above the trigger value of 100 L/kg. Concerning available ecotoxicity data, also the T criterion is not fulfilled. Furthermore, no classification exists as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No. 1272/2008. The test substance is neither classified as "T, R48" or as "Xn, R48" based on the criteria laid down in Directive 67/548/EEC nor as STOT-RE category 1 or 2 so far.
As conclusion, the test item fulfils no relevant criterion. Therefore, making all allowances for regulatory parameters available, the substance is neither PBT nor vPvB.
- Likely routes of exposure:
The test item is produced, supplied and marketed in the presence of a liquid mineral oil solvent, thus neither direct nor indirect exposure of the solely substance to the environmental compartments is intended. Workers may be exposed via the dermal route due to substance handling during manufacture. Based on the substance specific properties (i.e. logPow of 6.79) the substance will be able to diffuse into the dermis but no deeper layers of the skin, i.e. neither the epidermis nor any bloodstream layers will be crossed. Based on the low vapour pressure of the substance, an uptake via the inhalative route is not relevant. Oral exposure is not relevant based on the handling, education and safety precautions in the factory. As conclusion, only the dermal exposure route may be relevant for humans.
Reference
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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