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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
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
Reference Type:
review article or handbook
Title:
Annual report of the American Association of Poison Control Centers National Data Collection System.
Author:
Litovitz, T.L. et al.
Year:
1988
Bibliographic source:
Am J Emerg Med 6: 479-515

Materials and methods

Study type:
poisoning incident
Endpoint addressed:
acute toxicity: oral
Principles of method if other than guideline:
Annual report of the American Association of Poison Control Centers National Data Collection System. 3 cases of fatal methanol ingestion were reported.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): methanol
- Analytical purity: no data

Method

Subjects:
- Number of subjects exposed: 3
Route of exposure:
oral
Reason of exposure:
other: no data
Exposure assessment:
not specified

Results and discussion

Clinical signs:
Blood levels were 175, 402, and 39 mg/dl, respectively.

Applicant's summary and conclusion