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Toxicological information

Epidemiological data

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Administrative data

epidemiological 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

Referenceopen allclose all

Reference Type:
review article or handbook
Maternal occupational risk factors for oral clefts.
Lorente, C. et al.
Bibliographic source:
Scan J Work Environ Health 26: 137-145
Reference Type:
NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Methanol.
National Toxicology Program
Bibliographic source:
NIH Publication No. 03-4478, Sept 2003

Materials and methods

Study type:
other: review
Endpoint addressed:
developmental toxicity / teratogenicity
Principles of method if other than guideline:
Review of the developmental toxicitiy of methanol in humans.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): methanol (in complex mixtures; not further specified)
- Analytical purity: no data


Details on study design:
no data
Exposure assessment:
not specified

Results and discussion

No association was found between methanol exposure and oral clefts, but there are several limitations. Because of the limitations (see confounding factors and weaknesses) the Panel judged the study results to be uncertain and concluded there are insufficient data upon which to evaluate the developmental toxicity of methanol in humans.
Confounding factors:
other chemical exposures
Strengths and weaknesses:
Weaknesses: Limitations of the study were raised: small number of subjects exposed to methanol, lack of individual exposure data.

Applicant's summary and conclusion