Reaction mass of methyl acetate and methanol

Toxicity to terrestrial plants

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to terrestrial plants: short-term

Data waiving:

exposure considerations

Justification for data waiving:

other:

Reference 2

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Exposure of wheat root tips to methanol

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Species:

other: wheat (var. Eroica)

Plant group:

Monocotyledonae (monocots)

Details on test organisms:

- Common name:
- Plant family: Poaceae
- Variety: Eroica

Test type:

other: growth promoting of wheat roots

Study type:

laboratory study

Substrate type:

other: nutrient solution

Limit test:

no

Total exposure duration:

7 d

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

60 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: cell elongation (dark)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

900 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell elongation (light)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

70 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell multiplication (dark)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

60 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell multiplication (light)

Isolated wheat roots in light and in the presence of iron show a marked inhibition of the cell elongation. This inhibition is reversed by some primary alcohols and cell length is restored. However, Methanol examined has very little or no effect, either in light or in darkness. No toxicity of Methanol was observed.

Validity criteria fulfilled:

not applicable

Reference 3

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Principles of method if other than guideline:

Not specified

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

not specified

Details on preparation and application of test substrate:

not specified

Species:

other: other terrestrial plant

Validity criteria fulfilled:

not applicable

Reference 4

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Principles of method if other than guideline:

not further specified

Specific details on test material used for the study:

not further specified

Analytical monitoring:

not specified

Details on sampling:

not specified

Vehicle:

not specified

Details on preparation and application of test substrate:

not specified

Species:

other: other terrestrial plant like Phaseolus vulgaris, Raphanus sativus radicula, Lepidum sativum, Trifolium pratense, Saintpaulia and Petunia hybrids

Plant group:

other: not further specified

Details on test organisms:

not reported

Test type:

not specified

Study type:

other: not further specified

Substrate type:

not specified

Post exposure observation period:

not further specified

Test temperature:

not further specified

pH:

not further specified

Moisture:

not further specified

Details on test conditions:

not further specified

Nominal and measured concentrations:

not further specified

Reference substance (positive control):

not specified

Reference 5

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Vehicle:

no

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

60 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: cell elongation (dark)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

900 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell elongation (light)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

70 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell multiplication (dark)

Key result

Species:

Triticum aestivum

Duration:

7 d

Dose descriptor:

EC50

Effect conc.:

60 other: M

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Cell multiplication (light)

Reference 6

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

Please refer to IUCLID section 13 for Read Across Justification.

Reason / purpose for cross-reference:

read-across source

Reference 7

Endpoint:

toxicity to terrestrial plants: short-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

Please refer to IUCLID section 13 for Read Across Justification.

Reason / purpose for cross-reference:

read-across source

Reference 8

Endpoint:

toxicity to terrestrial plants: long-term

Data waiving:

exposure considerations

Justification for data waiving:

other:

Description of key information

Toxicity to terrestrial plants - short-term

In accordance with section 1.2 of Annex XI to Regulation EC 1907/2006 (REACH) short-term testing of toxicity to terrestrial plants is considered scientifically not necessary and was waived.

Toxicity to terrestrial plants - long-term

In accordance with section 1.2 of Annex XI to Regulation EC 1907/2006 (REACH) long-term testing of toxicity to terrestrial plants is considered scientifically not necessary and was waived.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for terrestrial plants:

1 555 mg/kg soil dw

Additional information

According to section 1.2 (weight of evidence) of Annex XI to Regulation (EC) No 1907/2006 weight of evidence from several independentsources of information leading to the assumption/conclusion that asubstance has or has not a particular dangerous property may be sufficient to address a specific endpoint. It is moreover specified that “where sufficient weight of evidence for the presence or absence of a particular dangerous property is available (…) further testing not involving vertebrate animals may be omitted.” 

The registration substance was assessed to be readily biodegradable (see IUCLID section 5.2.1) and there is no indication that it has potential to bioaccumulate or adsorb to the soil matrix (please see IUCLID section 5.4.1). Based on its intrinsic properties the substance is not regarded to be PBT or vPvB (please refer to IUCLID section 2.3). Thus, in case of indirect exposure of soil, the substance is expected to rapidly degrade and not to persist or bioaccumulate. Supporting information presented below shows that the read across source substance Methanol has a very low toxicity to terrestrial plants. The lowest NOEC of 1555 mg/kg dw was taken as key value for chemical safety assessment. Further, the substance showed a low ecotoxicity to other test organisms; e.g. the 72-hour EC10 and EC50 regarding the growth inhibition of algae was determined based on a read across to the structural analogue Methyl acetate to be > 120 mg/L (please refer to IUCLID section 6.1.5). By following worst case assumptions the registration substance is not classified for environmental hazards in accordance with Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182 (please see endpoint summary for IUCLID chapter 6). Furthermore, chemical safety assessments revealed that the registration substance as well as its structural analogues Methanol and Methyl acetate do not bear any risk for the environment (please refer to the chemical safety report attached to IUCLID section 13 and to the disseminated ECHA REACH dossiers for the read across source substances).

In sum, soil is not expected to be a compartment of concern and hazard to terrestrial plants is considered negligible. Therefore, further testing is scientifically not justified.

Supporting information

In the disseminated ECHA REACH dossier for the source substance Methyl acetate this endpoint was waived because of exposure considerations and its very low toxicity. Information on the toxicity to terrestrial plants available for the read across source substance Methanol is discussed below.

In a laboratory growth promoting test by Gudjonsdottir and Burström (1962) isolated wheat (var. Eroica) roots were grown in aseptic cultures. Root tips of about 7 mm length were cut from seedlings that had germinated for three days. Cultures were kept in 100 mL Erlenmeyer flasks for seven days, three root tips in each flask 10 mL nutrient solution. Isolated wheat roots in light and in the presence of iron showed a marked inhibition of the cell elongation. This inhibition was reversed by some primary alcohols and cell length was restored. However, Methanol had very little or no effect, either in light or in darkness. In this thest Methanol was found to be non-toxic to wheat. The following effect values were derived:

Triticum aestivum (wheat):

7-d EC50 (cell elongation, dark) = 60 M (nominal)

7-d EC50 (cell elongation, light) = 900 M (nominal)

7-d EC50 (cell multiplication, dark) = 70 M (nominal)

7-d EC50 (cell multiplication, light) = 60 M (nominal)

In another study plants such as Phaseolus vulgaris, Raphanus sativus radicula, Lepidum sativum, Trifolium pratense, Saintpaulia and Petunia hybrids were exposed to air containing methanol at concentrations between 0.4 and 2.5 mg/m³ for 14 days. Retarded growth, measured as the effect on both wet and dry weight of the plants, was reported for each species (van Haut and Prinz, 1979).

A Russian study (Nikolayevsky et al.) has indicated that plants may be sensitive to methanol vapour at concentrations >0.15 ppm (>0.2 mg/m³). Branches from eight different species of tree were studied and the permissible standard (0.15 ppm or 0.2 mg/m³) was taken as the concentration which did not produce a decrease in photosynthesis after 5 minutes exposure.

In the public ECHA REACH dossier for Methanol results of three unpublished studies on the toxicity of Methanol to terestrial plants (Hordeum vulgare, Elymus lanceolatus and Medicago sativa) are reported. Endpoints investigated were seed emergence, shoot length and dry mass, root length and dry mass. As only EC25 values were reported, NOECs for respective endpoints have been graphically derived from plots of these results. The NOECs derived for each species and endpoint ranged between 1555 and 20000 mg/kg dw. The lowest NOEC of 1555 mg/kg dw was taken as key value for chemical safety assessment. This value was supported by literature studies which indicate that Methanol has a very low toxicity to terrestrial plants.

Conclusion

Relevant and reliable information on the toxicity to terrestrial plants is available for the source substance Methanol. Based on a read across to Methanol a NOEC of 1555 mg/kg dw was determined and considered as key value for chemical safety assessment of the registration substance.