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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of (2-methoxyphenyl)methanol for effects in the environment:

 

The chemical(2-methoxyphenyl)methanol(CAS no. 612-16-8) isused as a fragrance in cosmetics. It is also used as an intermediate in organic synthesis, pharmaceuticals and agrochemicals.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for(2-methoxyphenyl)methanol. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradation study was conducted for 24 hrs at a temperature range of 28-30°C for evaluating the percentage biodegradability of test substance (2-methoxyphenyl)methanol (CAS no. 612-16-8) using Nocardia corallina B-276 ATCC 31338 (Herminia I. Perez et. al; 1998). Nocardia corallina B-276 ATCC 31338 was grown at 28–30°C on agar plates. Incubation of liquid cultures was done in an orbital shaker.Test inoculum was prepared in two procedures. InPreculture I -A 125 ml Erlenmeyer flask containing 50 ml of sterile culture medium was inoculated from an agar plate (three days old) and incubated at 28–30 °C on an orbital shaker (200 rpm) for 20–24 h and inPreculture II -The content of Preculture I flask was aseptically poured into a 250 ml Erlenmeyer flask containing 100 ml of fresh sterile culture medium. The flask was incubated at 28–30 °C on an orbital shaker (200 rpm) for 24 h.Erlenmeyer flask was used as a test vessel for the study.Under aseptic conditions the substrate (1 mmol – 138.165 mg/l) was added to the flask containing Preculture II using 1 ml of N,N-Dimethylformamide, followed by the addition ofn-octane (15 ml). The mixture (166 ml final volume) was incubated at 28–30 °C on an orbital shaker (200 rpm). The biotransformation was monitored by TLC, and stopped by acidifing to pH 1 with 0.05 M HCl, then saturated with NaCl and filtered through Celite; the carboxylic acids were extracted with ethyl acetate or dichloromethane (4X25 ml). The acids were purified by recrystallization.The percentage degradation of test substance(2-methoxyphenyl)methanol was determined to be 5% by TLC parameter in 24 hrs. Thus, based on percentage degradation, (2 -methoxyphenyl)methanol is considered to be not readily biodegradable in nature.

 

Experimental results from the read across substances (CAS: 122-99-6) also indicate that they are not readily biodegradable.

 

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 determined to beranges from 1.435 to 5.33, respectively and the octanol water partition coefficient of the test chemical ranges from 1.13 to 1.16, 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 estimations for invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range 105.647 – 407.572 mg/L. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for(2-methoxyphenyl)methanol. 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 fulfils the P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.