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EC number: 200-842-0 | CAS number: 75-12-7
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.6 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 21
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.952 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 21
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Exposure considerations
Formamide is registered as a transported isolated intermediate, i.e. human exposure should be minimal because production takes place in closed systems, and because formamide itself is not placed on the market.
Worker: There is an exposure potential for workers involved in the manufacture of formamide in industrial setting. Exposure via the inhalation route is very limited because of the low vapour pressure, and a low saturation concentration of 0.055 mg/L. A significant exposure may therefore only be given under conditions which allow the generation of aerosols.
General population: The exposure of the general population is considered to be negligible because formamide is only used as an intermediate, thus there is no designed expsoure f the general population.
ADME considerations(i.e. absorption, distribution, metabolism, excretion)
Formamide may be absorbed upon all routes of exposure. The dermal and inhalation routes are regarded to be the most relevant for humans (NTP, 2007).
Formamide toxicity profile
The acute toxicity of formamide is low (oral LD50, rat 5325 mg/kg bw; dermal LD50, rat>3000 mg/kg bw; LC50, rat>21 mg/L).
Data on skin and eye irritation indicate that local effects are negligible. Formamide was of mild toxicity in subchronic oral and dermal studies, and in a subacute inhalation study. NOAEL values could be derived for all routes of exposure, based on hematological changes. Red blood cells were considered to represent the main systemic toxicity target. The NOAEL values were 40 (oral; NTP, 2007) and 100 (dermal; BASF. 1985) mg/kg bw/day, and 0.19 mg/L (inhalation; Warheit, 1989).
Formamide was a developmental toxicant in rodents and rabbits at or below maternal toxic doses. The main effect was fetotoxicity, malformation occurred also but at much higher doses. The lowest NOAEL was 50 mg/kg bw/day in these studies (NTP, 1998; 2001).
The carcinogenic potential of formamide was examined in rats and mice. There was no evidence of carcinogenicity in male and female rats. Equivocal results were obtained in female mice, and a clear positive evidence of carcinogenicity was obtained in male mice (hemangiosarcoma statistically significantly increased at 40 an 80 mg/kg/day) with a NOAEL of 20 mg/kg/ bw/day. Formamide was not genotoxic. It is assumed that the mode of action is related to the damage of red blood cells which, on one hand, leads to stimulation of erythropoesis and related hematological changes on one hand, and on the other hand cause increased levels of iron which result in oxydative stress and damage of susceptibel vessels. Thus, there there is no genotoxic basis for the observed carcinogenicity, and a threshold is assumed below whhich carcinigenic effects are not considered to occur. Therefore, a DNEL may be derived rather than a DMEL.
Derivation of DNEL values
The following DNELs will not be derived:
Worker, Short-term DNEL, because there were no effects that would require classification. Moreover, the chronic DNEL will also protect against short term exposures.
General population; there is no designed exposure, hence a DNEL is not required.
Derivation of Worker, chronic DNELs:
The
potential of a substance to cause long-term systemic effects can be
judged based on the results of repeated dose toxicity and reproductive
(fertility and developmental) testing.
For formamide, the following NOAELs are presented in the IUCLID dossier:
subchronic (13 wk) dose effects, oral route (5/week), rat: NOAEL = 40 mg/kg/day
reproduction toxicity, 2 -generation study, rat: NOAEL = 85 mg/kg/day
developmental toxicity, dosing gestational days 6 -19, rat: NOAEL = 50 mg/kg/day
carcinogenicity; 2 year, oral gavage (20, 40, 80 mg/kg /day, 5/week), mouse: 20 mg/kg bw/day
A DNEL based on the chronic NOAEL (20 mg/kg bw/day) will be protective against possible effects on fertility and the fetus as well as adult systemic, or local, or short effects.
Dermal
Dose descriptor
A chronic mouse oral NOAEL of 20 mg/kg/day will be used.
Modification of dose descriptor
Correct the NOAEL to adjust for differences in duration of exposure (convert the corrected mouse oral NOAEL (mg/kg/day) into a human dermal NOAEL (mg/kg/day) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, Example B.5).
It is assumed that uptake of formamide after oral ingestion is 100%, while dermal absorption in humans is also 100%.
Oral NOAEL (5 days/week) = 20 mg/kg/day
correctedDermal NOAEL = Oral NOAEL x [ABSoral-rat/ABSdermal-human]
correctedDermal NOAEL = 20 x 1
= 20 mg/kg/day
Assessment factors
Uncertainty |
AF |
Justification |
Interspecies differences |
7 |
default for allometric scaling from mice to humans |
Intraspecies differences |
3 |
default for workers (ECETOC) |
Differences in duration of exposure |
1 |
default factor for chronic to chronic extrapolation |
Dose response and endpoint specific/severity issues |
1 |
default AF; clear NOAEC |
Quality of database |
1 |
default; GLP-compliant guideline study |
Overall AF |
21 |
|
DNELdermal = 20/21
= 0.952 mg/kg/day
Inhalation
The chronic worker DNELdermalmay be used to derive the chronic worker DNELinhalation.
Chronic DNELdermal = 0.952 mg/kg/day
Uptake worker = 0.952 mg/kg/day x 70 kg body weight
= 66.64 mg/day
Chronic DNELinhalation = uptake/respiration volume per shift
= 66.64 mg/day / 10 m³/day
= 6.66 mg/m³
It should be stressed that the Carcinogens and Mutagens Directive (2004/37/EC) requires that exposure to carcinogens is avoided or minimised as far as technically feasible.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Formamide is used as an intermediate, and is not placed on the market itself or in preparations. The general population is therefore not considered to be exposed.
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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