Reaction mass of methyl acetate and methanol

PBT assessment

PBT assessment: overall result

Reference

Name:

Reaction Mass of Methyl Acetate and Methanol

Type of composition:

legal entity composition of the substance

State / form:

liquid

Reference substance:

Reaction Mass of Methyl Acetate and Methanol

Reference substance:

Reaction Mass of Methyl Acetate and Methanol

PBT status:

the substance is not PBT / vPvB

Justification:

Conclusion on P/vP: not P/vP

Based on a read across to the source substances Methanol and Methyl acetate the registration substance is considered to be readily biodegradable. The mean degradation rate of Methyl acetate based on oxygen was > 68% within the 10-day window and reached 70% at the end of the test period. Methanol is readily biodegradable in freshwater based on the results of standard ready tests that show 71.5 – 95 % removal after 5 and 20 days, respectively (please refer to IUCLID section 5.2.1). Thus, the registration substance is considered not P/vP according to the ECHA Guidance on Information Requirements and Safety Assessment, chapter R.11, PBT/vPvB assessment (version 3.0, June 2017).

Conclusion on B/vB: not B/vB

According to the ECHA Guidance on Information Requirements and Safety Assessment, chapter R.11, PBT/vPvB assessment (version 3.0, June 2017) the screening criterion for bioaccumulation potential for aquatic organisms is a Log Kow > 4.5. The screening criteria for bioaccumulation potential for air-breathing organisms are a Log Kow > 2 and a Log Koa > 5. Following an analogue read-across approach the Log Kow of the substance was determined to be 0.18 (please refer to IUCLID section 4.7). The Log Koa for the read across substance Methanol (CAS no. 67-56-1)  is considered to be 2.880, for the read across substance Methyl acetate (CAS no. 79-20-9) 2.310 (KOAWIN v.1.10, experimental database). Hence, the screening criteria for bioaccumulation potential are not fulfiled and the registration substance is regarded to be non-bioaccumulative for aquatic and air-breathing organisms. Based on the chemical structure and physicochemical properties of the registration substance a non-lipophilic biocaccumulation is not expected. In conclusion, the registration substance is not B/vB.

Conclusion on T: T-criterion fulfilled

The lowest ecotoxicological long-term (chronic) effect value was determined based on a read-across approach to the structural analogue Methanol (CAS 67-56-1). The 21-day NOEC for Daphnia magna was found to be >100 mg/L (please refer to IUCLID section 6.1.4), which is clearly below the trigger value of EC10 or NOEC >= 0.01 for marine / freshwater organisms (long-term toxicity). Morover, the substance is not classified as carcinogenic, mutagenic or toxic to reproduction according to Directive 67/548/EEC or carcinogenic, germ cell mutagenic or toxic to reproduction according to Regulation EC No 1272/2008. However, the substance has to be classified STOT RE category 1 according to Regulation EC No 1272/2008. Therefore, the substance is regarded toxic (T) in compliance with above mentioned criteria and the ECHA Guidance on Information Requirements and Safety Assessment, chapter R.11, PBT/vPvB assessment (version 3.0, June 2017).

Overall conclusion on PBT/vPvB:

The substance is neither P/vP nor B/vB, but considered T. The substance is hence not PBT or vPvB in accordance with Regulation EC No 1907/2006 (REACH) and the ECHA Guidance on Information Requirements and Safety Assessment, chapter R.11, PBT/vPvB assessment (version 3.0, June 2017).