Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Maternal occupational risk factors for oral clefts.
Author:
Lorente, C. et al.
Year:
2000
Bibliographic source:
Scan. J. Work Environ. Health 26, 137-145
Reference Type:
publication
Title:
NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Methanol.
Author:
National Toxicology Program
Year:
2003
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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methanol
EC Number:
200-659-6
EC Name:
Methanol
Cas Number:
67-56-1
Molecular formula:
CH4O
IUPAC Name:
Methyl alcohol

Method

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

Results and discussion

Results:
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