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EC number: 200-001-8 | CAS number: 50-00-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Upper Airway Cancer, Myeloid Leukemia, and Other Cancers in a Cohort of British Chemical Workers Exposed to Formaldehyde
- Author:
- Coggon D., et al.
- Year:
- 2 014
- Bibliographic source:
- Am J Epidemiol. 2014 Jun 1;179(11):1301-11
Materials and methods
- Study type:
- cohort study (retrospective)
- Endpoint addressed:
- carcinogenicity
- Principles of method if other than guideline:
- The authors extended follow up of a cohort of 14,008 chemical workers at 6 factories in England and Wales, covering the period 1941–2012. Mortality was compared with national death rates for England and Wales, and associations with incident upper airway cancer and leukemia were explored in nested case-control analyses.
- 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:
- occupational
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- A follow-up through December 2012 was conducted in the British (UK) cohort from six factories comprising 14,008 men in the period 1941–2012
Mortality was compared with national death rates for England and Wales.
At 5 factories, all male employees were enrolled, while at the sixth (British Petroleum), where only a small proportion of the workforce had been exposed to formaldehyde, recruitment was limited to formaldehyde workers and a subset of men who had worked in other parts of the plant (2 for each exposed man).
The cohort was traced through the National Health Service Central Register (now the Health and Social Care Information Centre) and in some cases national insurance records, and was followed through December 31, 2012. For men who had died, the authors obtained the underlying and contributing causes of death, coded to the Ninth (deaths through the end of 2000) or Tenth (deaths since 2000) revision of the International Classification of Diseases. For those with registered cancers, the authors obtained information on the type of cancer and the date of registration.
Additionally, a nested case-control analyses of 115 men with upper airway cancer (including 1 nasopharyngeal cancer), 92 men with leukemia, and 45 men with myeloid leukemia was performed. ORs for these cancers were independent of the duration of the exposure - Exposure assessment:
- estimated
- Details on exposure:
- An occupational hygienist classified job titles according to their exposure to formaldehyde (background, low, moderate, high, or unknown).
Measurements of formaldehyde were not available from before 1970, but from later measurements and workers’ recall of irritant symptoms, it was estimated that background exposure corresponded to time-weighted concentrations of <0.1 ppm, low exposure to 0.1–0.5 ppm, moderate exposure to 0.6–2.0 ppm, and high exposure to >2.0 ppm.
Within each factory, each job title was assigned to the same exposure category across all time periods, but the same job title was not necessarily classified in the same exposure category at different factories. - Statistical methods:
- Person-years method to compare the mortality of cohort members with that of the national population of England and Wales, according to category of exposure.
Results and discussion
- Results:
- Mortality in the cohort was significantly higher than expected from national rates (standardized mortality ratio (SMR) = 1.05, 95% confidence interval: 1.03, 1.08). However, the study provides no evidence that formaldehyde poses an increased hazard either of upper airway cancer or of myeloid leukemia. The increased mortality was probably attributable to non-occupational confounding factors.
- Strengths and weaknesses:
- The authors ascribed the increases in risk estimates to non-occupational confounding factors, which may include smoking and socioeconomic factors. It was noted that the study was not able to take smoking and socioeconomic factors into account.
Applicant's summary and conclusion
- Conclusions:
- Mortality in the cohort was significantly higher than expected from national rates (standardized mortality ratio (SMR) = 1.05, 95% confidence interval: 1.03, 1.08). However, the study provides no evidence that formaldehyde poses an increased hazard either of upper airway cancer or of myeloid leukemia. The increased mortality was probably attributable to non-occupational confounding factors.
- Executive summary:
A follow-up through December 2012 was conducted in the British (UK) cohort from six factories comprising 14,008 men in the period 1941–2012
Mortality was compared with national death rates for England and Wales.At 5 factories, all male employees were enrolled, while at the sixth (British Petroleum), where only a small proportion of the workforce had been exposed to formaldehyde, recruitment was limited to formaldehyde workers and a subset of men who had worked in other parts of the plant (2 for each exposed man).
The cohort was traced through the National Health Service Central Register (now the Health and Social Care Information Centre) and in some cases national insurance records, and was followed through December 31, 2012. For men who had died, the authors obtained the underlying and contributing causes of death, coded to the Ninth (deaths through the end of 2000) or Tenth (deaths since 2000) revision of the International Classification of Diseases. For those with registered cancers, the authors obtained information on the type of cancer and the date of registration.
Additionally, a nested case-control analyses of 115 men with upper airway cancer (including 1 nasopharyngeal cancer), 92 men with leukemia, and 45 men with myeloid leukemia was performed. ORs for these cancers were independent of the duration of the exposure
A total of 9,172 cohort members had exposures above the background level, including 3,991 who at some time were highly exposed. In the period, 7,378 men had died, 5,449 were still alive, and the other 1,181 had been lost to follow-up. Overall mortality in the cohort was significantly higher than expected from national rates (standardized mortality ratio (SMR) = 1.05, 95% confidence interval: 1.03, 1.08). The standardised mortality ratio [SMRs (95 % CI)] for all cancers [1.10 (1.06–1.15)], stomach [1.29 (1.11–1.49)], rectum [1.23 (1.01–1.49)], and for lung cancer [1.26 (1.17–1.35)] was significantly increased based on the national death rate for England and Wale. The nested case-control analyses of 115 men with upper airway cancer (including 1 nasopharyngeal cancer), 92 men with leukemia, and 45 men with myeloid leukemia indicated no elevations of risk in the highest exposure category (high exposure for ≥1 year). There was no excess mortality from nasopharyngeal cancer; the only death occurred in a man with low/moderate exposure (1.7 deaths expected for exposures above background).
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