Registration Dossier
Registration Dossier
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EC number: 807-159-2 | CAS number: 69701-99-1
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- MEDOL-10
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- MEDOL-10
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
The mean percentage biodegradation of MEDOL-10 calculated by biological oxygen demand (BOD) dissolved organic carbon concentration (DOC) and gas chromatography (GC) was 29.7, 33.1 and 100 % respectively. The percentage biodegradation by BOD and DOC were similar, while that obtained by GC resulted in a comparatively high value. The percentages of the metabolites remaining were estimated.
The remaining metabolite was identified as MEDOL-COOH (4-carboxyl-2-ethyl-2-methyl-1,3-dioxolane). This metabolite was oxidised from MEDOL_OH (4-hydroxymethyl-2-ethyl-2-methyl-1,3-dioxolane), one of the two hydrates of test item, the other being acrylic acid. Acrylic acid is readily biodegradable substance and disappear from the test solution, while MEDOL-OH and MEDOL-COOH remained.
Whilst some degradation was observed we cannot classify it as inherent therefore based on these results Medol 10 is concluded as not biodegradable.
The screening criteria indicates the substance may be persistent or very persistent. No higher tier studies are available (ie simulation testing) therefore insufficient data are available to permit a definitive conclusion on vP criteria. In the absence of any data to the contrary it must be assumed the substance possesses P or vP properties.
Bioaccumulation
The n-octanol/water partition coefficient of the substance is Log Kow 1.92. The substance is therefore considered to have low bioaccumulation potential and is therefore not B or vB.
Toxicity
No long term aquatic toxicity data are available however according to the ECHA guidance document Chapter R.11: PBT/vPvB assessment following the flow chart provided in Figure R11-5 all EC50 values for acute aquatic toxicity studies are > 0.1mg and the log KoW < 4.5 therefore Medol 10 does not meet the T-criterion.
There are no data available to assess carcinogenicity. For mutagenic effects all in-vitro studies were in conclusive. In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen.
There was no evidence of any significant organ damage during the 28day repeat dose oral study .
Based on the data above the substance does not meet criteria for T properties.
Overall it is concluded that the substance is not a PBT substance.
Reference
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