Recyclamine R 401

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis- for effects in the environment:

 

The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for test chemical 2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis- (Recyclamine R 401) (CAS no. 2267262-14-4). 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

Biodegradation study was conducted for 28-days Closed Bottle test following the OECD guideline 301 D for determining 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. Activated sludge, collected from Bhandewadi STP, Nagpur, was used as inoculum in the study. This was pre-conditioned at the test temperature. 1 mL supernatant was diluted to 100 mL with mineral medium and from this solution 0.05 mL was added to 125 mL test bottles. This gave the bacterial count as 10E4 to 10E6 CFU/L. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 0.4 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 91.62%. Degradation of Sodium Benzoate exceeds 32.93% on 7 days & 74.85% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid.The BOD28 value of test chemical was observed to be 1.53 mgO2/mg. ThOD was calculated as 2.2 mgO2/mg. Accordingly, the % degradation of the test chemical after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 69.55%. Based on the results, the test item, under the test conditions, was considered to be readily biodegradable in nature.

 

Thus, based on the available information, it indicates that chemical 2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis- (Recyclamine R 401) (CAS no. 2267262-14-4) was considered to bereadily biodegradablein water and 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 estimated BCF value from authoritative database was evaluated to be ranges from 1 to 5.04, respectively and theoctanol water partition coefficient of the test chemical was determined to be 2.025±0.003 at 25°C as per the OECD guideline no. 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 substance 2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis- (Recyclamine R 401) (CAS no. 2267262-14-4) indicates the LC50/EC50 value to be in the range 19.93 to 458.46 mg/L, respectively. Since, the test chemical is readily biodegradable in water, test chemical is likely to be non-hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be ‘’not classified’’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for chemical 2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis- (Recyclamine R 401). 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.