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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
hypothesis As a hypothesis, methanol is the critical constituent of the substance (S-Ethanol, composition 2) based on its amount and with regards to its hazardous properties. It is the major constituent affecting the classification and labeling of the target substance (S-Ethanol). Therefore, data from methanol is used in the read-across approach in order to update the hazard assessment of this substance. Other impurities are taken into account for self-classification but there were no need to consider evaluating their properties in hazard assessment because of low concentrations. Analogue approach justification This substance (S-Ethanol, composition 2) has degree of ethanol purity between 76.4-81.9 %. Methanol is the main impurity of the target substance (conc. 13-14 %), and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For chemical safety assessment certain physico-chemical properties are relevant for both human health and environmental health assessment. Also they are important for self-classification and for updating of the exposure assessment of the target substance. For toxicological endpoints, methanol is considered the major drivers for classification and overall safety assessment of the target substance. Therefore, methanol properties were included for chemical safety assessment and the endpoint robust summaries were provided also for methanol.

Data source

Reference Type:
No information
Mc Nally, W.D.
Bibliographic source:
Toxicology, Industrial Medicine Publisher, Chicago, 615

Materials and methods

Type of study / information:
Information on occupational methanol poisoning.
Endpoint addressed:
repeated dose toxicity: inhalation
Principles of method if other than guideline:
Several cases of occupational methanol poisioning by inhalation and frequently symptoms were reported.
GLP compliance:

Test material

Details on test material:
- Name of test material (as cited in study report): methanol (not further specified)
- Analytical purity: no data


Exposure assessment:

Results and discussion

Headache and blurred vision were reportedly frequent symptoms. It is believed, that absorption of 8 grams would seriously affect the eyes and that such a dose could result from inhalation of 1.06 to 1.33 mg/L (corresponding to 800 to 1000 ppm) for 8 hours. Work room concentration of 0.67 to 0.8 mg/L (corresponding to 500 to 600 ppm) were found. It is recommended to keep the levels below 1 ppm.

Applicant's summary and conclusion