Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
Benzene, C10-13-alkyl derivs
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
Reference substance:
Benzene, C10-13-alkyl derivs
PBT status:
the substance is not PBT / vPvB
Justification:

Annex XIII of the REACH Regulation (1907/2006) lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), as well as the information that must be considered for the purpose of assessing the P, B, and T properties of a substance. The criteria require that all available information is to be used, employing a weight-of-evidence approach. Substances must meet all three criteria to be considered PBT. The table below shows both the PBT and vPvB criteria:

Property

PBT Criteria

vPvB Criteria

Persistence:

The assessment shall be based on available half-life data collected under adequate conditions

T½> 60 days in marine water, or T½> 40 days in fresh- or estuarine water, or T½> 180 days in marine sediment, or T½> 120 days in fresh- or estuarine sediment, or T½> 120 days in soil

T½> 60 days in marine, fresh or estuarine water, or T½> 180 days in marine, fresh- or estuarine sediment, or T½> 180 days in soil

Bioaccumulation:

The assessment of bioaccumulation shall be based on bioconcentration in aquatic species. Data from freshwater and/or marine species can be used.

BCF > 2000 L/kg

BCF > 5000 L/kg

Toxicity

NOEC (long-term) <0.01 mg/L for marine or freshwater organisms, or Substance is classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3), or There is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

T½equals the half-life of the substance in the appropriate biodegradation study; NOEC is the no observable effect concentration

Persistence Assessment
LAB was found to be readily biodegradable in the OECD manometric respirometry test, with 64% biodegradability in 28 days. Therefore, LAB is not persistent.

Bioaccumulation Assessment
A key study using method ASTM E-35.31 was conducted to assess the bioaccumulation potential in fish. Results indicate a half-life of 15.3 days and a BCF of 35. Therefore, LAB is not bioaccumulative.


Toxicity Assessment
Studies show that LAB is normally not toxic to aquatic organisms at the limits of water solubility. In a 21-day chronic study with Daphnia the resultant EC50 was 0.012 mg/L and NOEC was 0.0075 mg/L. However, this study used a high level of a solvent to solubilise the LAB. A new OECD 211 study was conducted using the WAF (water accommodated fraction) approach and no toxicity was observed to Daphnia at the level of water solubility. Therefore, LAB does not meet the PBT criteria for chronic aquatic toxicity. LAB is not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3), and no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Summary and overall Conclusions on PBT or vPvB Properties
Based on the data collected and the discussion above, LAB does not meet the criteria for either PBT or vPvB.




Categories Display