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Repeated dose toxicity: inhalation

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repeated dose toxicity: inhalation
Type of information:
other: Review
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comprehensive scientific review. Reviewed data as well as the review itself published in peer reviewed journals.

Data source

Reference Type:
review article or handbook
Lowest adverse effects concentrations (LOAECs) for formaldehyde exposure
Gelbke H.P., et al.
Bibliographic source:
Regulatory Toxicology and Pharmacology 70 (2014) 340–348

Materials and methods

Principles of method if other than guideline:
The authors discuss the scientific literature available for cell replication, histopathological alterations and tumour response (polypoid adenomas),s and present new statistical analyses for cell replication and tumour response (polypoid adenomas). Data is discussed in relation to the conclusion of the Committee for Risk Assessment (RAC) of the European Chemicals Agency which concluded that 2 ppm formaldehyde represent a Lowest Observed Adverse Effect Concentration (LOAEC) for polypoid adenomas, histopathological lesions and cell proliferation.
GLP compliance:
Limit test:

Test material

Test material form:
other: no additional information
Specific details on test material used for the study:
Name of test material (as cited in study report): Formaldehyde

Administration / exposure

Route of administration:

Results and discussion

Results of examinations

Details on results:
In this review the assessments of RAC is assessed and the following conclusions are drawn:
- PA (papillomas, polypoid adenomas) are not related to development of squamous cell carcinomas (SCC) and the data do not allow to define a LOAEC or NOAEC.
- For histopathological alterations a NOAEC of 1 ppm can be derived and lesions at 2 ppm are not related to SCC development.
- For cell replication the total database clearly justifies a NOAEC of 2 ppm and LOAECs of 3 ppm to 4 ppm.

Effect levels

Basis for effect level:
Remarks on result:
not measured/tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion