Dodecan-1-ol, ethoxylated

PBT assessment

PBT assessment: overall result

Reference

Name:

Dodecan-1-ol, ethoxylated

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

Dodecan-1-ol, ethoxylated

Reference substance:

Dodecan-1-ol, ethoxylated

PBT status:

the substance is not PBT / vPvB

Justification:

Classification ofDodecan-1-ol, ethoxylatedfor effects in the environment:

 

The chemical Dodecan-1-ol, ethoxylated (CAS no. 9002-92-0) is used as solvent, nonionic emulsifier, pharmaceutical surfactant, spermaticide, topical anesthetic, antipruritic, and sclerosing agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forDodecan-1-ol, ethoxylated. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance does not fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Various experimental studies and predicted data of the test chemical were reviewed for the biodegradation end point which are summarized as below:

 

In an experimental key study from authoritative databases (2018), biodegradation experiment was conducted for 28 days for evaluating the percentage biodegradability of test chemical. The study was performed according to OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I) under aerobic conditions. Activated sludge was used as a test inoculum for the study. Concentration of inoculum i.e, sludge used was 100 mg/l and initial test substance conc. used in the study was 30 mg/l, respectively. The percentage degradation of test chemical was determined to be 74, 44 and 62% by BOD, TOC removal and UV-Vis parameter in 28 days. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in nature.

 

Another biodegradation study was conducted for 30 days for evaluating the percentage biodegradability of test chemical (HSDB, 2017). The study was performed according to OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test) under aerobic conditions. Activated sludge was used as a test inoculum for the study. Initial test substance conc. used in the study was in the range 2-5 mg/l, respectively. The percentage degradation of test chemical was determined to be 74-84% by BOD parameter in 28 days. Thus, based on percentage degradation, test chemical is considered to be readily biodegradable in water.

 

Estimation Programs Interface Suite (2018) was run to predict the biodegradation potential of the test chemical in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that test chemical is expected to be readily biodegradable.

 

On the basis of above results for test chemicalDodecan-1-ol, ethoxylated, it can be concluded that the test chemical was considered to be readily biodegradable in natureand thus likely to be not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol water partition coefficient of the test chemical was determined to 2.260 ± 0.001 at 25°C as per the OECD TG 117, which is less than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substanceDodecan-1-ol, ethoxylatedindicates the LC50/EC50 value to be in the range 2.737 to 9.13 mg/L, respectively and on the basis ofthe estimated data oflong term eco-toxicity data for fish and aq. Invertebrates, the NOEC value was determined to be ranges from 0.139 to 0.144 mg/l, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be classified in ‘Aquatic Chronic Category 3’ as per the CLP regulation.

 

By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.