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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Captan
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
> 96.14 - < 97.13 % (w/w)
Reference substance:
Captan
Reference substance:
Captan
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

Applying criteria of Annex XIII of regulation 1907/2006 captan is assessed as not being PBT due to the following information:

 

Persistence:

Hydrolysis of captan in sterile buffer solutions is in a range from 18.8 hours in acidic to 8.3 minutes in alkaline water. Even in environmental systems fast degradation is found: sediment water (DT50=1.5 h); soil (DT50=0.91 d);

Captan is assessed not to be persistent.

 

Bioaccumulation

The BCF in fish was found to be 140 (Suprenant, 1988). A substance is accounted to be bio accumulating with a BCF higher than 2000 (1907/2006, Annex XIII – 1.1.2). Additionally threshold value of 4 for log Kow is not reached with log Kow (Captan) = 2.57.

Captan is not bio accumulative as bioaccumulation criterion is not met.  

 

Toxicity

(a) the long-term no-observed effect concentrations (NOEC) for captan were determined for fish to be 0,056 mg/L (Sankey 1991), for aquatic invertebrates 0.56 mg/L (Stewart 1991) and the NOEC for freshwater algae to be 0.8 mg/L (Smyth 1991).

The criteria from Annex XIII, 1.1.3 (long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms is less than 0,01 mg/l) are not met.

(b) ) Captan is neither classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), nor toxic for reproduction (category 1A, 1B, or 2) according to Regulation EC 1272/2008;

(c) For Captan there is no evidence of chronic toxicity, e.g specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.

Captan is assessed not to be toxic.

 

Overall based on the above mentioned criteria captan is not PBT according to regulation 1907/2006.

Likely routes of exposure:

Emission characterisation data for captan is not required since the substance does not meet the criteria to be considered as PBT or vPvB substance.

 

Significant environmental emissions in respect to uses mentioned within this dossier are not expected, as only one site for formulation was identified and only technical applications are kown leading to further reaction of captan. Additionally captan is an active substance registered in accordance with regulation 1107/2009 with detailed analyses on environmental exposure effects.