Registration Dossier
Registration Dossier
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EC number: 228-846-8 | CAS number: 6362-80-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is PBT / vPvB
- Justification:
Persistence: The test item is considered to be P but not vP. The inherent biodegradability of the test material was assessed according to OECD guideline 302 C. The test item attained 75%, 83% and 34% degradation with a mean of 64% degradation calculated from oxygen consumption values after 28 days. Under the conditions of this study, as the substance attained >20 % over 28 days the substance can be considered as inherently biodegradable. However, in accordance with REACH Guidance on information requirements and chemical safety assessment, Chapter R11: PBT Assessment, as the substance did not attain 70 % degradation over 14 days this is a clear indication that the substance will not biodegrade and should be regarded as persistent. Furthermore, the hydrolysis as a function of pH of the test item was assessed according to OECD guideline 111. The half-life for hydrolysis was considered to be > 1 year which also indicates that the substance should be classified as persistent.
Bioaccumulation: The test item is considered to be B but not vB based on 2,000 < BCF ≤ 5,000 L/kg, as identified in Annex XIII criteria of REACH. The bioaccumulative potential of the test item was assessed according to GLP and to the test method relating to New Chemical Substances (Kanpogyo No. 5, Yakuhatsu No. 615, 49 Kikyoku No. 392, 1974; partially revised 1998). The concentration rate (BCF) was 427-3330 at high concentration and 423-4410 at low concentration. Therefore, under the conditions of this study the test item should be considered as bioaccumulative but not very bioaccumulative.
Toxicity: The test item is considered to be T. In a repeat dose toxicity study, the no-effect level of the test item was found to be less than 45 mg/kg/day in males and 45 mg/kg/day in females because of effects on the liver. As such, the substance should be classified as Specific Target Organ Toxicity Repeated Exposure Category 2 in accordance with Regulation 1272/2008. Furthermore, in accordance with Regulation 1272/ 2008, the substance meets the criteria as an acute aquatic hazard category 1 as the EC50 and LC50 results from 3 acute, aquatic toxicity studies are ≤ 1 mg/L (for fish, the 96-Hour LC50 based on the time weighted mean was >0.092 mg/L; for algae, the 72-hour EC50 was > 0.059 mg/L (maximum attainable concentration); for Daphnia, the 48-h EC50 was found to be 0.057 mg/L). The substance also meets the criteria as a chronic aquatic hazard category 1 as the substance is not readily biodegradable, the BCF value was experimentally determined as 4410 and the Log Pow has been determined as 6.2
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