Alcohols, C16-18

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

Alcohols, C16-18

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Related composition:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference 2

Name:

Alcohols, C16-18

Type of composition:

boundary composition of the substance

State / form:

solid: bulk

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

Reference substance:

Alcohols, C16-18

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, C16-18 (CAS# 67762-27-0) is from the category of Long Chain Alcohols (C6-22 primary aliphatic alcohols) .

Persistence Assessment:

 

Data of following studies are demonstrating rapid biodegradation Alcohols, C16-18 under aerobic conditions.

 

 Morris, P.A., Filler, P.A., and Nielsen, A.M. (1991) conducted OECD 301B test and the result is that 21-65% at 20 mg/Lof Degradation was achieved within 28 days. The test substance required 5 extra days for a total of 15 days to reach 60% of maximum theoretical carbon dioxide production.The substanceachieved ready test pass levels, but not within the 10 day window.  

 

Henkel KGaA. , 1999conducted OECD 301D test for Biodegradation of Alcohols, C16-18.

58% degradation was attained by day 7, the substance and 81% by day 28 and the substance is considered to be readily biodegradable.

 

Henkel KGaA. , 1999conducted ISO Draft (BOD Test for Insoluble Substances) test for Biodegradation of Alcohols, C16-18.

Degradation was 56 - 62 % after 28 day(s) , the substance is considered to be readily biodegradable.

 

Henkel KGaA. , 1999 conducted also another ISO Draft (BOD Test for Insoluble Substances) test for Biodegradation of Alcohols, C16-18.

Degradation was 81 - 100 % after 28 day(s) , the substance is considered to be readily biodegradable

 

The BIOWIN QSAR predicts that the substance Alcohols, C16-18 will be readily biodegradable.

 

Table     Summary of Biodegradation

 

Type/ Method	Test material	Degradation	Duration	References
Aerobic/ OECD 301B	Alcohols, C16-18	21-65% in 28 days at 20 mg/L	28 days	Morris, P.A., Filler, P.A., and Nielsen, A.M. (1991)
Aerobic/ OECD 301D	Alcohols, C16-18	81% 58%	28days 7 days	Henkel KGaA. , 1999
Aerobic/ ISO Draft (BOD Test for Insoluble Substances)	Alcohols, C16-18	56 - 62 %	28 days	Henkel KGaA. , 1999
Aerobic/ ISO Draft (BOD Test for Insoluble Substances)	Alcohols, C16-18	81 - 100 %	28 days	Henkel KGaA. , 1999

 

 

      

Therefore,Alcohols, C16-18 is not persistent.

 

Bioaccumulation Assessment:

 

Bioaccumulation is considered to be low for Alcohols, C16-18 which is from the category of Long Chain aliphatic Alcohols, which are rapidly metabolised in higher organisms.

The estimated Log BCF of Alcohols, C16-18 is 2.74 (BCF = 544 L/kg wet-wt). This substance has a limited potential to bioaccumulate (based on log Kow used by BCF estimates: 6.73, and predicted bioconcentration factors, log BCF = 2.74 (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, C16-18 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, C16-18 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, C16-18 is not considered to be bioaccumulative.

 

Toxicity Assessment:

None of the long-term NOECs for marine or freshwater organisms are 0.01 mg /L. Alcohols, C16-18 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, C16-18 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, C16-18 does not meet the criteria for either PBT or VPvBas 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.