Registration Dossier
Registration Dossier
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EC number: 701-135-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The test item attained 25% biodegradation after 28 days according to OECD Guideline No 302B and therefore can be considered to be inherently, primarily biodegradable and therefore do not meet the P criterion.
The n-octanol/water partition coefficient (log value) of the substance is 0.467. Low potential for bioaccumulation in aquatic species was observed in an OECD 305 study. The estimated BCF values (0.023 for the substance itself and 0.027 for the main metabolite) are below the trigger for assignment as a bioaccumulative or very bioaccumulative substance.
A study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and was designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996).
The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 300 mg/kg bw/day. There was an effect on reproduction at this dosage leading to no pregnant animals being available for assessment. The No Observed Adverse Effect Level (NOAEL) for reproduction and the survival, growth and development of the offspring therefore was considered to be 100 mg/kg bw/day. As the effects were considered unusual a confirmatory experiment was conducted and the reproductive effects were confirmed. Classification as a Category 1b reproductive toxicant fulfils the criteria for 'T'.
Based on the assessment described in the sub-sections, above the substance is considered T but is not PB/vPvB
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