Registration Dossier
Registration Dossier
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EC number: 217-420-7 | CAS number: 1843-03-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is considered persistent. The substance is not readily biodegradable (12% in 28 days). The extremely low water solubility prevents assessment of the hydrolysis of the substance by testing but assessment of the chemical structure suggests that the substance is stable and will not hydrolyse.
The substance is not bioaccumulative. The log Pow estimated by QSAR is 12.6962 by structural fragmentation by KOWWIN. Furthermore, the QSAR assessment of BCF by Arnot-Gobas BCF & BAF Methods estimated a BCF of 1.064 L/kg wet-wt.
The toxicokinetic data available on a close structural analogue conducted with a radioisotope demonstrates that the substance is not metabolised in a mammalian system and only trace levels absorbed to blood and tissues (0.06%) or excreted in urine. The data demonstrates that 28% was located in the GI tract with the total remaining mass balance (71%) excreted in faeces.
The substance is not toxic. The substance is highly water insoluble. In consequence exposure to three aquatic species has been investigated at nominal concentrations. The toxicological examination of freshwater fish, daphnia and algae resulted in no toxic effect and all data were completed as limit tests.
The substance has been assessed for genetic toxicity by three in vitro assays with and without metabolic activation. All three endpoints demonstrate a lack of mutagenic response.
The screening reproduction toxicity study on a close structural analogue demonstrates a lack of effects to parent and F1 animals with no effects to reproduction.
On the basis of the genetic and reproduction toxicity data available, in addition to the repeated dose toxicity data the substance is considered to not present the potential for carcinogenic hazard.
The data from one subchronic mammalian toxicity study are available by dietary exposure. The study achieved a NOAEL at 500 mg/kg/day with effects at high dose limited principally to reduced body weight gain due to reduced food intake and liver cytoplasmic vacuolation. The substance is not classified on the basis of these data and no further toxicological examination is considered necessary for hazard assessment.
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