Reaction mass of methyl acetate and methanol

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to bees: acute oral

Data waiving:

exposure considerations

Justification for data waiving:

other:

Reference 2

Endpoint:

toxicity to bees: chronic oral

Data waiving:

exposure considerations

Justification for data waiving:

other:

Justification for type of information:

none

Description of key information

Toxicity to terrestrial arthropods - short-term

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

Toxicity to terrestrial arthropods - long-term

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

Additional information

According to section 1.2 (weight of evidence) of Annex XI to Regulation (EC) No 1907/2006 weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance 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. 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). 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. A 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).

In sum, soil is not expected to be a compartment of concern and hazard to soil dwelling organisms is considered negligible. Consequently, further testing is scientifically not justified.