Registration Dossier
Registration Dossier
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EC number: 201-185-2 | CAS number: 79-20-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 300 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 777 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 620 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
As the systemic OEL derived from methanol is similiar to the OEL derived by MAK for methyl acetate the value of 310 mg/m3 (100ppm) is used for risk assessment as DNEL longterm. The DNELacute is
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 64 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 777 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 133 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.5 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 203 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.5 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 203 mg/kg bw/day
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Intraspecies variation: worker = 5 consumer = 10 --> factor 2 for correction worker to consumer.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Inhalation
The critical effects of methyl acetate are due to the systemic effects of the metabolites methanol and formic acid. As the amount of methanol excreted in the urine after the exposure of volunteers to methyl acetate was the same as that after exposure to equivalent concentrations of methanol, the OEL value for methanol can also be adopted as threshold for methyl acetate to cover systemic effects.
At higher concentrations methyl acetate leads to irritating effects in the nose after repeated exposure.
In an OECD guideline 412 study, rats (Hsd: Sprague Dawley SD; 10/sex/group) were exposed nose-only to concentrations of methyl acetate (purity: >99.5%) of 0, 79, 335, and 2018 ppm (analytical concentrations: 0, 244, 1035, and 6236 mg/m3), 6 hours/day, 5 days/week, for 28 days (HMR, 1999). An additional group of 10 animals per sex were exposed to about 2000 ppm to characterize the elimination kinetics of methyl acetate It was not possible to detect methyl acetate in blood due to rapid elimination. No compound-related mortality or clinical signs (including neurological disturbances) were seen in any of the exposed groups in the main study. In the high-concentration group, a moderate but, significant decrease in body weights (by 10%) and food consumption was observed. As a consequence absolute and relative organ weights were reduced. There were significant changes in blood parameters, clinical chemistry, and urinalysis in the high dose group. Apart from, mostly moderate, degeneration and necrosis of the olfactory epithelium in 19/20 animals of the high-concentration group, no abnormalities were seen in any other organ or organ system in any other group upon macroscopic and microscopic examination. In the mid-concentration group, there were no changes in haematology, clinical chemistry, or urinalysis parameters. From this 28-day inhalation rat study a NOEC of 335 ppm (1035 mg/m³) can be derived. Damage to the nasal olfactory epithelium was found at the next higher concentration of 2018 ppm (6236 mg/m³).
However, distance of concentration levels between mid dose and high dose is extreme. The MAK Commission concluded that it is feasible to assume that 500 ppm would still be a NOAEC. This conclusion is also consistent with the ECHA Guidance document suggesting a extrapolation factor of 3 for extrapolation from a LOAEC to a NAEC of 3 (2000 ppm: 3 = 666 ppm). An OEL of 100 ppm (305 mg/m³) was set by the MAK commission based on irritating effects to the upper respiratory tract (detailed evaluation see MAK documentation 2017). The official commitee for OELs in Germany however concluded recently that 200 ppm (620 mg/m3) can be read across as OEL for methyl acetate based on the similarity of local effects to ethyl acetate exposure. Therefore, this value can be adopted for methyl acetate as threshold for loacl effects on the respiratory tract.
All other inhalation thresholds required by REACH can be calculated by introducing the respective additonal uncertainty factors and corrections.
Dermal exposure
No local hazard was identified for methyl acetate exposure. There are no suitable studies available for evaluating absorption of the substance through the skin. However dermal penetration rate may be regarded as high in a worst case approach. The respective systemic theshold can be extrapolated form the inhaltion route values.
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