Reaction mass of methyl acetate and methanol

Toxicity to soil microorganisms

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil microorganisms

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

In accordance with section 1.2 of Annex XI to Regulation EC 1907/2006 (REACH) short-term testing of toxicity to soil microorganisms 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. 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).

Studies on the toxicity of Methanol and Methyl acetate demonstrated that both source substances are not hazardous to aquatic microorganisms (please refer to IUCLID section 6.1.7). Steinhäuser (1989) carried out a "Mikrotoxtest" with Methyl acetate and derived a EC10 and EC50 (16h) of 1730 mg/L and 6100 mg/L, respectively. Bringmann and Kuehn (1978) determined a toxic treshold value (TGK) of 530 mg/L in a 192-hour test with Microcystis aeruginosa. The same authors report a further toxic threshold value resulting from a cell multiplication test for 16 hours, using two Pseudomonas species, at 6600 mg/L (Bringmann and Kuehn 1977). An IC50 value >1000 mg/L for activated sludge is reported by Klecka et al. (1985). This test was performed according to the OECD Guideline 209 (activated sludge, respiration inhibition test) and is considered the most appropriate for assessing the risk for aquatic microorganisms.

In conclusion, soil is not expected to be a compartment of concern and hazard to soil microorganisms is considered negligible. Therefore, further testing is scientifically not justified and was waived in accordance with section 1.2 (weight of evidence) of Annex XI to Regulation (EC) No 1907/2006.