Methyl anthranilate

PBT assessment

PBT assessment: overall result

Reference

Name:

methyl anthranilate

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

methyl anthranilate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Methyl anthraniilatefor effects in the environment:

 

The chemicalMethyl anthraniilate(CAS no. 134-20-3) is used to make perfumes and flavors. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forMethyl anthraniilate. 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 anexperimental biodegradation study from several different reliable sources of the chemicalMethyl anthraniilate(CAS no. 134-20-3), percentage biodegradation rate of test chemical in water was determined. Study was carried out for 20 days under the condition of optimal bacterial growth. Test chemical was purchased from Fluka Chemical Company. The initial concentration of test chemical used in the study was 50 mg/L. Test chemical concentration was determined by High performance liquid chromatography (HPLC). The HPLC system consisted of a Rainin HPXL solvent delivery system, Dynamax A1-2 autosampler equipped with a 2 0 4 fixed sample loop and a Dynamax UV-M ultraviolet detector. Quantitative analysis of test chemical was done by using Hewlett Packard 3390A recording integrator. Brucker MSL-400 (400 MHz) NMR spectrometer, Finnegan GC/MS spectrometer equipped with a Data General Nova computer system, a Shimadzu IR-435 infrared spectrophotometer and a Gilford 2600 ultraviolet spectrophotometer were used for the spectral analysis. Approximately 50 mg liter of two solution of test chemical were prepared in dechlorinated, charcoal-filtered Vessels which were stored open to natural inoculation in a water bath maintained at 13-15°C for seven days prior to initiation of the test. One tank received 1 g of sodium azide, a metabolic poison after seven days resulting in a final concentration of 0.1 g liter. There is no further treatment given to control tank. 100 ml of samples were drawn, sealed (to prevent further inoculation) and stored at 23°C in sterilized, sealed amber vials. Vials were stored under dark or light: dark (12: 12 h) conditions. Aliquots from all treatments were analyzed for test chemical content at intervals of 0, 0.2, 1, 2, 5, 6, 7, 8, 9 and 20 days post-treatment. Under conditions of optimal bacterial growth (warmth and darkness), biodegradation of test chemical was determined to be 100% in 20 days. Based on the test chemical analysis, test chemical was considered to be readily biodegradable in water.

 

Experimental results from the read across substances also indicate that they are readily biodegradable.

 

Thus, based on the available information, it indicates thatchemicalMethyl anthraniilatewas considered to be readily biodegradable in water and thus likely to be not persistent (not P) in nature.

 

Environmental fate

In an experimental study, biodegradation in soil study was performed for 64 days using a 1% suspension of Niagara silt loam soi with a complete degradation of test chemicalMethyl anthraniilatein 64 days.

 

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to be 66.2%). In soil,Methyl anthraniilatewas expected to have moderate mobility based upon a Log KOC value of 1.87. The half-life in soil (30 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

 

If released in to the environment, 32.9% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1. However, the half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% i.e reported as 0.105% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded thatchemicalMethyl anthraniilateis not persistent 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 peer reviewed journals and authoritative databases was evaluated to be< 2000 and the octanol water partition coefficient of the test chemical from various reliable sources was evaluated to be in the range 1.88 to 1.9, 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 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 substanceMethyl anthraniilate(CAS no. 134-20-3)indicates the LC50/EC50 value to be in the range 9.12 to > 151.16 mg/L, respectively. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations. Since, the test chemical is readily biodegradable in water, chemical was considered as non-toxic and hence, considered to be classified ‘not classified’ as per the CLP regulation.

 

On the basis of long term eco-toxicity data for fish and aq. invertebrates, the NOEC/EC50/LC50 value was determined to be ranges from 7.22 & 4.36 mg/l, 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.