Registration Dossier
Registration Dossier
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EC number: 433-360-6 | CAS number: 34036-80-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence assessment:
Biodegradation in water: screening test: The substance is not ready biodegradable (test method according to OECD Guideline 301B, GLP).
Hydrolysis: The substance is hydrolytically unstable in water (test method in accordance with OECD Guideline 111, GLP). The half-life is < 5 minutes at pH 4, 7 and 9 and at 25 ºC and therefore, the substance is not persistent.
Conclusion on P / vP properties: The substance is not fulfilling the criteria for Persistence (P).
Bioaccumulation assessment:
The substance hydrolyses very rapidly in water (half-life < 5 min). The relevant hydrolysis product that will eventually end up in the environment is butanone oxime (MEKO). Based on a log Kow value for butanone oxime of 1.69 (estimated by EPI-Suite, KOWWIN v1.68), it can be concluded that the substance does not fulfill the criteria to be regarded as bioaccumulative.
The substance undergoes rapid hydrolysis in aqueous to butanone oxime and the corresponding phenylsilanetriol. According to the bioaccumulation test in carp fish performed by MITI, butanone oxime has a low bioaccumulation potential (BFC= (0.5)-(0.6) at a concentration of 2 ppm, and <2.5 -(5.8) at a concentration of 0.2 ppm). Moreover, the silanols undergo continuous condensation reactions to produce higher molecular weight siloxanes which are considered biologically unavailable. Therefore, the substance butan-2-one O,O',O''-(methylsilanetriyl)oxime is determined not to fulfil the criteria for bioaccumulation.
Conclusion on B / vB properties: The substance is not fulfilling the criteria for Biaccumulable (B)
Toxicity assessment:
There is no long-term toxicity studies available with fish and crustacea.
Toxicity to aquatic algae: NOEC (72h) = 4.34 mg/L (basis for effect: growth rate) (test method according to OECD 201, GLP study).
Moreover, regarding the acute aquatic toxicity:
- Short-term toxicity to fish: LC50 (96h) >= 89.8 mg/L (based on mortality) (test method according to OECD 203, GLP study).
- Short-term toxicity to aquatic invertebrates: EC50 (48h) >= 101 mg/L (based on mobility) (test method according to OECD 202, GLP study).
- Toxicity to aquatic algae: EC50 (72h) = 22 mg/L (based on growth rate) (test method according to OECD 201, GLP study).
The substance is not classified as CMR.
The substance is classified as STOT Rep. Exp. 2 (target organ: red blood cells) in accordance with CLP Regulation (EC) No 1272/2008, since significant toxic effects were observed in a 90-day repeated-dose study (oral) conducted in experimental animals within value ranges 10 -100 mg/kg bw/day.
Conclusion on T properties: The substance is determined to be T.
CONCLUSION:
2-butanone-O,O',O''-(phenylsilylidyne)trioxime is not a PBT or vPvB substance.
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