Registration Dossier
Registration Dossier
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EC number: 200-001-8 | CAS number: 50-00-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: Review
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Comprehensive scientific review. Reviewed data as well as the review itself published in peer reviewed journals.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Recent trend in risk assessment of formaldehyde exposures from indoor air
- Author:
- Nielsen D.G., Larsen S.T., Wolkoff P.
- Year:
- 2 013
- Bibliographic source:
- Arch Toxicol (2013) 87:73–98
Materials and methods
- Type of sensitisation studied:
- respiratory
- Study type:
- other: review of existing data
- Principles of method if other than guideline:
- Studies about the test substance (FA) published since the guideline of 0.1 mg/m³ by the World Health Organization (WHO) in 2010 have been evaluated.
- GLP compliance:
- no
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- CH2O
- IUPAC Name:
- formaldehyde
- Details on test material:
- - Name of test material (as cited in study report): formaldehyde
Constituent 1
Method
- Type of population:
- other: review of existing data
- Route of administration:
- inhalation
- Details on study design:
- Studies about the test substance (FA) published since the guideline of 0.1 mg/m³ by the World Health Organization (WHO) in 2010 have been evaluated.
The following studies regarding asthma and FA exposure were reviewed and relevant studies summarized in the CSR/IUCLID.
- Wolkoff and Nielsen 2010; Heinrich 2011; Golden 2011; McGwin et al. 2010; Garrett et al. 1999; Rumchev et al. 2002; Hulin 2010; Hwang et al. 2011; Kim et al. 2011; Annesi-Maesano et al. 2012.
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- None of the studies present a convincing association between test substance exposures and asthma, in agreement with previous studies.
- Executive summary:
- Investigation of the relationship between test substance exposure and asthma or other airway effects in children showed no convincing association.
- The authors conclude that, overall, recent field studies are about mixed exposures where the effects of the test substance are indistinguishable from effects of other components. None of the studies present a convincing association between test substance exposures and asthma, in agreement with previous studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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