Registration Dossier
Registration Dossier
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EC number: 236-885-7 | CAS number: 13532-94-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
Ready biodegradability of 2-Butoxyethyl methacrylate was investigated during a GLP-compliant study performed using a relevant OECD Testing Guideline 301D. This study concluded that the substance is ready biodegradable. Therefore it can be concluded that 2-Butoxyethyl methacrylate is not P or vP and does not meet the criteria for classification as PBT or vPvB.
Bioaccumulation:
A Log Kow of 2.47 at 25 °C was determined for 2-butoxyethyl methacrylate in the KOWWIN v1.68 model (EPI Suite v4.11). Since the Log Kow is ≤ 4.5, the substance does not meet the criteria to be B or vB.
Toxicity:
The toxicity of the substance was investigated in accordance with Annexes VII and VIII of REACH. Data on short-term toxicity of the registered substance to fish, aquatic invertebrates, and algae was provided. All L(E)C50 for short-term toxicity were above 1 mg/L and therefore above screening values for T properties described in Table R.11-6 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (ECHA, 2017).
2-Butoxyethyl methacrylate was NOT found to be mutagenic, in in-vitro gene mutation studies in bacteria, mammalian cells and in a micronucleus study, in accordance with Regulation EC n° 1272/2008. No studies were available to assess the carcinogenicity, reproductive/developmental toxicity and repeated dose toxicity of the substance , but human exposure was deemed not relevant.
The toxicity of the registered substance following a short-term repeated-dose exposure via the oral route was investigated in accordance with Annex VII of REACH. No significant treatment-related adverse effect was observed as a result of the exposure to the registered substance at up to 1,000 mg/kg bw/d.
Conclusion:
The substance is not considered to be PBT or vPvB.
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