Alcohols, C12-14

PBT assessment

PBT assessment: overall result

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 the 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.

This substance Alcohols, C12-14 (CAS#80206-82-2) is from the category of Long Chain Alcohols (C6-22 primary aliphatic alcohols) .

Persistence Assessment:

 

 

Data of following studies are demonstrating rapid biodegradation Alcohols, C12-14 under aerobic conditions.

 

 Henkel KGaA. , 1997 conducted BOD-test for Insoluble Substances (BODIS); ISO 10708 for Biodegradation of Alcohols, C12-14.

The test method used is based on OECD test method 301D and the RDA-Blok-Test. Mineral medium was inoculated with activated sludge and stabilized for one week at 18-22 C with continuous stirring. After stabilisation, 200 ml of test medium was filled into 300 ml bottles, aerated until O2 saturation was reached and spiked with test substance by directly weighing into the test vessels.

Degradation was 79 - 97 % after 28 day(s), the substance is considered to be readily biodegradable

 

The BIOWIN QSAR predicts that the substance Alcohols, C12-14 will be readily biodegradable.

 

Richterich , 1993 conducted OECD 301D test for Biodegradation of Alcohols, C12 (1-Dodecanol). Degradation was 79 % after 28 day(s) , the substance is considered to be readily biodegradable. Dodecan-1-ol (C12) is supporting substance for Alcohols, C12-C14 and the main component. The test substance (2 mg/l) attained >60% degradation during the 14 day window.

 

Henkel KGaA. , 1992 conducted OECD test method 301D and BOD-test for Insoluble Substances (BODIS); ISO 10708 for Biodegradation of Dodecan-1-ol (C12. Degradation was 100 % after 28 day(s) , the substance is considered to be readily biodegradable.

The substance degraded >60% in the 10 day window. .Dodecan-1-ol (C12) is supporting substance for Alcohols, C12-C14 and the main component.

Morris, P.A., Filler, P.A., and Nielsen, A.M. (1991) conducted OECD 301B test and Degradationwas 71 % after 28 day(s) , the substance is considered to be readily biodegradable. The substance degraded >60% in the 14 day window. .Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component. The reference substance Sodium acetate degraded by 78% after 28 days.

 

 

 

Table     Summary of Biodegradation in water:screening tests

 

Type/ Method	Test material	Degradation	Duration	References
Aerobic/ OECD 301D/(BODIS)	Alcohols, C12-14	79-97% in 28 days at 100 mg/L	28 days	Henkel KGaA. , 1997
Aerobic/ OECD 301D	Alcohols, C12 (1-Dodecanol).	79%	28 days	Richterich , 1993
Aerobic/ OECD 301D/(BODIS	Alcohols, C12  (1-Dodecanol).	100 %	28 days	Henkel KGaA. , 1992
Aerobic/ OECD 301D	Alcohols, C12 (1-Dodecanol).	71 %	28 days	Morris, P.A., Filler, P.A., and Nielsen, A.M. (1991)

 

 

 

      

Therefore,Alcohols, C12-14 is not persistent.

 

Bioaccumulation Assessment:

 

Bioaccumulation is considered to be low for Alcohols, C12-14 which is from the category of Long Chain aliphatic Alcohols, which are rapidly metabolised in higher organisms.

The estimated Log BCF of Alcohols, C12-14 is 1.677 (BCF = 47.59 L/kg wet-wt).This substance has a limited potential to bioaccumulate (based on log Kow used by BCF estimates: 5.13, and predicted bioconcentration factors, log BCF = 1.677 (EPIWIN/BCF Program).

A 96 hours, hexadecan-1-ol bioconcentration factors (BCFs) for the Brachydanio rerio (new name: Danio rerio) species ranged from 500 to 1000 (Unilever,1996).

These experimental and estimated BCF values suggest that Alcohols, C16-18 has a low potential for bioaccumulation.

Chain lengths C11 and above have log Kow >4.5 and so could be considered to be potentially bioaccumulative.

Two evidences result in the conclusion that Alcohols, C12-14 is not expected to be B/vB:

1. Due to rapid degradation combined with evidence of rapid metabolism in mammalian and fish studies, it is unlikely that bioaccumulation of Alcohols, C12-14 would be demonstrated in studies.

2. The conduct of guideline-standard studies of bioaccumulation in fish would be confounded by the technical difficulties of maintaining the test alcohol in solution according to results of other long-term studies with invertebrates. In these studies, severe difficulties were encountered in conducting the study as biodegradation of the substance in the test system was almost complete within the 24 h test media renewal period.

Therefore, Alcohols, C12-14 is not considered to be bioaccumulative.

 

  

Toxicity Assessment:

None of the long-term EC10 or NOECs for marine or freshwater organisms are below 0.01 mg/L. Alcohols, C12-14 not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3). There is no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC. Therefore Alcohols, C12-14 does not meet the PBT criteria for toxicity.

Summary and overall Conclusions on PBT or vPvB:

Properties Based on the data collected and the discussion above, Alcohols, C12-14 does not meet the criteria for either PBT or VPvB as it is readily biodegraded in the environment, has a very low bioaccumulation potential, low chronic aquatic toxicity and is not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.