1-dodecylpyridinium chloride

PBT assessment

PBT assessment: overall result

Reference

Name:

1-dodecylpyridinium chloride

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

1-dodecylpyridinium chloride

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 1-dodecylpyridinium chloride for effects in the environment:

 

The chemical 1-dodecylpyridinium chloride (CAS no. 104-74-5) is used as a surfactant, wetting agent, fungicide, bactericide and disinfectant agent. Also used in cleaning formulations, personal care products and deodorants, etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for1-dodecylpyridinium chloride. 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 fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

In an experimental study from study report, 35-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test chemical. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as a test inoculum for the study.The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 75.3%. Degradation of Sodium Benzoate exceeds 45.18% on 7 days & 70.48% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid.The BOD35 value of test chemical was observed to be 1.1 mgO2/mg. ThOD was calculated as 2.64 mgO2/mg. Accordingly, the % degradation of the test item after 35 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 41.66%. Based on the results, the test item, under the test conditions, was considered to be inherently biodegradable in nature.

 

Supporting studies of substance 1-Dodecylpyridinium chloride (DPC) (CAS no. 104-74-5) indicates 0% degradation and hence, it was considered to be not readily biodegradable.

 

Overall, based on the study report result, test chemical1-dodecylpyridinium chloride(CAS no. 104-74-5),test chemical was considered to be inherently biodegradable in waterand 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 be 0.671 ± 0.028 at 25°C as per OECD TG 117 and from authoritative database, it was reported to be0.84, respectively, 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 fulfils 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 substance1-dodecylpyridinium chloride(CAS no. 104-74-5) indicates the LC50/EC50 value to be in the range 0.16 to 12.5 mg/L, respectively and on the basis of long term eco-toxicity data for invertebrates, the LC50 value was determined to be in the range 0.05 to 0.25 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 acute/chronic category 1’ as per the CLP regulation.

 

By speculation, long-term NOEC for aquatic organisms can be expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

 

The chemical was therefore 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 fulfils the T criterion but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.