Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence
The available screening information indicates that Chlorhexidine digluconate is poorly biodegradable.
Further, the route and rate of degradation of chlorhexidine digluconate was investigated under aerobic conditions at 20 ± 2ºC in two contrasting water sediment systems in the dark (according to OECD308). Chlorhexidine digluconate was shown to degrade to unextractable sediment bound residues and minor metabolites only.Transfer of chlorhexidine digluconate from the water into the sediment was rapid with DT50 values of 1.4 and 4.1 days in the two systems tested. The rate of degradation in the total water/sediment systems was however slow, with DT50 values of >1000 and 277 days for Calwich Abbey and Swiss Lake systems, respectively.
Therefore, Chlorhexidine digluconate is considered to fullfill the vP criteria in the PBT/vPvB assessment .Bioaccumulation
Based on radioactivity measurements, the bioaccumulation factor was determined to be 40 - 42 L/kg. Uptake and depuration rates were not determined. For a log Pow of 1.58, (partition coefficient of Chlorhexidine base CAS 55-56-1) the BCF(earthworm) is calculated to be 9.5 L/kg. Due to this result, Chlorhexidine digluconate is not expected to accumulate in terrestrial biota.
Toxicity
The smallest NOEC/EC10 was found to be 0.0135 mg/L (algae test accoridng to OECD 201).The substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008. There is no other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC) or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. Therefore the substance is assigned to be not T.
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