Methyl formate

Long-term toxicity to aquatic invertebrates

Description of key information

Parent compound (CAS 107-31-3):

Data waiving according to Annex IX Regulation (EC) No 1907/2006

Moreover,the rapid hydrolysis will be the major fate process of the methyl formate under environmentally relevant conditions (pH 7-9). Therefore, this estimate may be of low relevance. Thus, the assessment of the long-term toxicity of the substance is based on the available experimental data for the hydrolytic products: formic acid and methanol.

 

Hydrolysis product methanol (CAS 67-56-1):

Key:

21 -d NOEC = 224 mg/l (OECD QSAR Toolbox v4.3.1, 2021)

 

Hydrolysis product formic acid (CAS 64-18-6):

Key:

21 -d NOEC >= 100 mg/L (BASF AG, rep. no.: 51E274/073100, 2007).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Remarks:

Hydrolysis product formic acid (CAS 64-18-6)

Effect concentration:

>= 100 mg/L

Fresh water invertebrates

Dose descriptor:

NOEC

Remarks:

Hydrolysis product methanol (CAS 67-56-1)

Effect concentration:

224 mg/L

Additional information

Parent compound (CAS 107-31-3):

In Annex IX Section 9.1.5 column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on invertebrates. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or CLP-Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB.

The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment.  

Moreover, according to the available hydrolysis study for the substance, Methyl formates' susceptibility to hydrolysis increases with pH as well as with temperature. The hydrolysis half-life ranges from 410 h at pH 4 and 20 °C to less than 1 hour at pH 9 and 25 °C (OECD 111, BASF SE, 2010). Therefore, it can be concluded, that under environmentally relevant conditions (pH 7-9) the rapid hydrolysis will be the major fate process of the methylformate due to the short half-life in aqueous solution. Therefore, this estimate may be of low relevance. Thus, the assessment of the long-term toxicity of the substance is based on the available experimental data for the hydrolytic products: formic acid and methanol.

Therefore, a long-term toxicity test on aquatic invertebrates is not provided.

Hydrolysis product methanol (CAS 67-56-1):

According to Annex XI, Section 1.3 of REACH, results obtained from valid qualitative or quantitative structure-activity

relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

— results are derived from a (Q)SAR model whose scientific validity has been established,

— the substance falls within the applicability domain of the (Q)SAR model,

— results are adequate for the purpose of classification and labelling and/or risk assessment, and

— adequate and reliable documentation of the applied method is provided.

 

The long-term toxicity on aquatic invertebrates has been assessed using the OECD QSAR Toolbox v4.3.1. A 21-d NOEC for reproduction of Daphnia magna was derived using a trend analysis of the standardized workflow for ecotoxicological endpoints as provided by the Toolbox. The resulting 21-d NOEC was 224 mg/L. The Substance is within the applicability domain of the model. A robust study summary for this endpoint has been provided, which contains all relevant and required information. Therefore, the Registrant will not perform a study on the long-term toxicity to aquatic invertebrates.

Hydrolysis product formic acid (CAS 64-18-6):

The chronic test with formic acid using Daphnia magna as test species was performed according to OECD TG 211. No adverse effects (reproduction, weight, length) were observed up to the highest concentration of 100 mg/l. Therefore, the NOEC based on reproduction and growth was determined to be > 100 mg/L, indicating no adverse long-term effects (BASF AG, rep. no.: 51E274/073100, 2007).