L-Glutamic acid, N-coco acyl derivs., monosodium salts

PBT assessment

PBT assessment: overall result

Reference

Name:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

Reference substance:

l-Glutamic acid, N-coco acyl derivs., monosodium salts

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Phenethyl phenylacetate for effects in the environment:

 

The chemical L-Glutamic acid, N-coco acyl derivs., monosodium salts(CAS no. 68187-32-6) is used in cleaning agent, air care products and cosmetics. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forL-Glutamic acid, N-coco acyl derivs., monosodium salts. 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

42-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 under aerobic conditions. The test system included control, test item, reference item and toxicity control. Polyseed were used for this study. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 1 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 74.85%. Degradation of Sodium Benzoate exceeds 59.88% on 7 days & 77.84% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid. The BOD42 value of test chemical was observed to be 0.45 mgO2/mg. ThOD was calculated as 0.85 mgO2/mg. Oxygen depletion in the inoculum blank did not exceed 1.5 mg dissolved oxygen/L after 28 days. The residual conc. of oxygen in test bottles did not fall below 0.5 mg/L at any time, % degradation of reference compound has reached the pass levels (60% of ThOD) by day 14 and in a toxicity test, containing both the test substance and a reference compound, >25% biodegradation occurred within 14 days,  test substance cannot be assumed to be inhibitory. Thus, fulfilling the validity crtieria as per OECD test guideline and hence, study is considered to be valid. Accordingly, the % degradation of the test chemical after 42 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 52.94%. Based on the results, the test chemical, under the test conditions, was considered to be inherently biodegradable in nature.

 

On the basis of above results for test chemicalL-Glutamic acid, N-coco acyl derivs., monosodium salts, it can be concluded that the test chemical was considered to beinherently biodegradablein 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 (Kow) of the test chemical was determined to 0.597 at 25°C (logKow = -0.224) as per the shake flask method, 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 the available data of short term eco-toxicity for fish and algae of the substance L-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS no. 68187-32-6) as per OECD TG 201 indicates the LC50/EC50 value was evaluated to be >120 mg/l and >100 mg/l, respectively. Further, on the basis of the available short-term eco-toxicity data for aq. invertebratesof the structurally and functionally similar read across chemical and applying the weight of evidence approach,for the substance L-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS no. 68187-32-6) indicates LC50/EC50 value as >100 mg/l. These value suggest that the substance is likely to be not hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be ‘Not classified’ as per the CLP regulation.

 

On the basis of the long term toxicity data of fish and aquatic invertebrates, the 28 d & 21 d NOEC value was evaluated to be 23.58 mg/l (for fish) and 13.47 mg/l (for aquatic invertebrate), respectively.

 

Thus, 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.