Reaction mass of methyl acetate and methanol

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

Please refer to IUCLID section 13 for Read Across Justification.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1 mg/cm²

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Reference 2

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Principles of method if other than guideline:

Acute filter paper test with Eisenia fetida

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of application to filter paper: Methanol was dissolved in acetone, or other suitable solvent, and 1 mL of the solution was pipetted into each vial. A stream of warm air was directed into the vial to aid in evaporation of the solvent. After the vials had been under the stream of warm air for 3 min, they were air-dried for an additional 2 h to remove all remaining solvent. Then, 1 mL of water was added to each vial to moisten the paper and one earthworm was placed into each vial.
- Controls: Control vials received only the 1 mL of acetone
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone, or other suitable solvent
- Evaporation of vehicle before use: yes; a stream of warm air was directed into the vial to aid in evaporation of the solvent

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Source: Bert's Bait Farm, Irvine, KY, USA
- Age at test initiation (mean and range, SD): Mature worms showing a developed clitellum
- Weight at test initiation (mean and range, SD): 370 to 450 mg

ACCLIMATION
- Acclimation conditions: worms were housed in Nalgene boxes filled with moist peat moss and rabbit manure, and stored at 18°C. Calcium carbonate was added as necessary to maintain soil pH above 5.5

Study type:

laboratory study

Substrate type:

filter paper

Limit test:

no

Total exposure duration:

48 h

Details on test conditions:

TEST SYSTEM
- Test container: glass shell vials (22 mm x 85 mm) (Research Products International, Mt. Prospect, IL, USA) were lined with Whatman No. 1 filter paper strips (9.5 cm x 6.8 cm, surface area, 65 cm 2) and placed in cardboard scintillation vial trays. Vials were capped.
- No. of organisms per container (treatment): 1
- No. of replicates per treatment group: 10
- No. of replicates per control: 1
- a minimum of 100 earthworms was tested in order to determine the LC50

OTHER TEST CONDITIONS
- Photoperiod: dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: geometric series of five to seven concentrations
- Range finding study
- Test concentrations: 0.1, 1, 10, 100, 1000 µg/cm2 (nominal)
- Results used to determine the conditions for the definitive study: The approximate lethal concentration was considered to be the lowest exposure that killed 50 % or more of the earthworms.

Nominal and measured concentrations:

0.1, 1, 10, 100, 1000 µg/cm2 (nominal)

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1 mg/cm²

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Validity criteria fulfilled:

not applicable

Conclusions:

In an acute filter paper test similar to OECD Guideline 207 the the 48-hour LC50 was determined to be > 1 mg/cm^2 (nominal).

Executive summary:

An acute filter paper test with Eisenia fetida similar to OECD Guideline 207 was performed. In this test setup Methanol was solved using a solvent (acetone or any other suitable solvent; not further specified). Before use a stream of warm air was directed into the vial to aid in evaporation of the solvent. Worms were exposed for 48 hours to nominal concentrations of 0.1, 1, 10, 100, 1000 µg/cm2. No reference control but a vehicle control was performed. Death was recorded if the worm did not respond to gentle probing of its anterior end. Worms that were severely morbid, even having lost their posterior half but still responding to the probe, were considered alive. As a result, the 48-hour LC50 > 1 mg/cm2 (nominal).

Reference 3

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Data waiving:

exposure considerations

Justification for data waiving:

other:

Description of key information

Toxicity to soil macrooganisms except arthropods - short-term

Based on a read across to the source substance Methanol the LC50 for short-term toxicity to soil macroorganisms is considered to be 10000 mg/kg soil dw.

Toxicity to soil macrooganisms except arthropods - long-term

In accordance with section 9.4.4, column 2 of Annex X as well as section 1.2 of Annex XI to Regulation EC 1907/2006 (REACH) long-term testing of toxicity to soil macroorganisms except arthropods is considered scientifically not necessary and was waived.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:

10 000 mg/kg soil dw

Additional information

Short-term toxicity to soil macroorganisms except arthropods

Reliable information for the source substance Methanol is available and presented below.

Key information

An acute filter paper test with Eisenia foetida similar to OECD Guideline 207 was performed (Roberts and Dorough 1984). In this test setup Methanol was solved using a solvent (acetone or any other suitable solvent; not further specified). Before use a stream of warm air was directed into the vial to aid in evaporation of the solvent. Worms were exposed for 48 hours to nominal concentrations of 0.1, 1, 10, 100, 1000 µg/cm2. No reference control but a vehicle control was performed. Death was recorded if the worm did not respond to gentle probing of its anterior end. Worms that were severely morbid, even having lost their posterior half but still responding to the probe, were considered alive. As a result, the 48-hour LC50 > 1 mg/cm² (nominal). In the study Eisenia foetida was used as the marker species to indicate the relative toxicities of several chemicals and other soil invertebrates. Based on the LC50 value methanol was classified as relatively non toxic.

Conclusion

In a study by Roberts and Dorough (1984) LC50 of the source substance was found to be > 1 mg/cm²(nominal). By applying a read across approach, the LC50 on long-term toxicity of the target substance for soil macroorganisms is considered to be 10000 mg/kg soil dw.

Long-term toxicity to soil macroorganisms except arthropods

In accordance with section 9.4.4 , column 2 of Annex X to Regulation EC No 1907/2006 (REACH) long-term toxicity testing on invertebrates shall be proposed by the applicant “if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment.”

A full chemical safety assessment according to Annex I of the same regulation was carried out including an environmental hazard assessment, an environmental exposure estimation as well as a risk characterisation for the registration substance. The assessment was based on a read across to the structural analogues Methanol and Methyl acetate. A sound rationale for this approach is provided in the read across justification attached to IUCLID section 13. 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. The chemical safety assessment 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).

Furthermore, 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. Further, the substance showed a low ecotoxicity to other test organisms. In a read across to the source substance Methanol the LC50 for short-term toxicity to soil macroorganisms (except arthropods) was determined to be 10000 mg/kg soil dw. Also for aquatic invertebrates no toxic potential of the substance was identified as evident by valid tests with the structural analogues Methanol and Methyl acetate (for details please refer to IUCLID section 6.1). In sum, soil is not expected to be a compartment of concern and hazard to soil dwelling organsims is considered negligible.

Consequently, the registration substance is deemed non-hazardous to terrestric invertebrates and further testing is thus scientifically not justified.

This conclusion also fully complies with the criteria stipulated in section 1.2 (weight of evidence) of Annex XI to Regulation (EC) No 1907/2006 according to which 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.” 

Therefore, this endpoint was waived.