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EC number: 267-051-0
CAS number: 67774-74-7
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:
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
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
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.
the half-life of the substance in the appropriate biodegradation study;
NOEC is the no observable effect concentration
LAB was found to be readily
biodegradable in the OECD manometric respirometry test, with 64%
biodegradability in 28 days. Therefore, LAB is not persistent.
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.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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