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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- , peripheral blood was obtained from mice of the 90-day repeated dose study
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Formamide
- EC Number:
- 200-842-0
- EC Name:
- Formamide
- Cas Number:
- 75-12-7
- Molecular formula:
- CH3NO
- IUPAC Name:
- formamide
- Details on test material:
- - Name of test material (as cited in study report): Formamide
- Analytical purity: approx. 100%
The test material was examined using IR-, UV-/visible light spectroscopy, proton nuclear magnetic resonance spectroscopy, TC, GC, and HPLC.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- cf. repeated oral dose study; section 7.5.1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle /solvent used: water
- Details on exposure:
- - oral gavage study
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 5 treatments/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 20, 40, 80, and 160 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 per dose and sex
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- Preipheral blood; normochromatic and polychromatic erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Dose selection for the 90-day oral gavage study was based on preceding 14-day studies.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Treatment: 13 weeks, 5 days/week.
Sampling: from peripheral blood at the end of the 0-day study.
DETAILS OF SLIDE PREPARATION:
A detailed discussion of this assay is presented by MacGregor et al. (1990). At the end of the 3‑month toxicity study, peripheral blood samples were obtained from male and female B6C3F1 mice. Smears were immediately prepared and fixed in absolute methanol. The methanol‑fixed slides were stained with acridine orange and coded.
METHOD OF ANALYSIS:
Slides were scanned to determine the frequency of micronucleated cells in 2,000 normochromatic erythrocytes (NCEs) in each of 10 animals per treatment group. In addition, the percentage of polychromatic erythrocytes (PCEs) in a population of 1,000 erythrocytes was determined as a measure of bone marrow toxicity. - Evaluation criteria:
- In the micronucleus test, an individual trial is considered positive if the trend test P value is less than or equal to 0.025 or if the P value for any single dosed group is less than or equal to 0.025 divided by the number of dosed groups. A final call of positive for micronucleus induction is preferably based on reproducibly positive trials (as noted above). Ultimately, the final call is determined by the scientific staff after considering the results of statistical analyses, the reproducibility of any effects observed, and the magnitudes of those effects.
- Statistics:
- The results were tabulated as the mean of the pooled results from all animals within a treatment group plus or minus the standard error of the mean. The frequency of micronucleated cells among NCEs was analyzed by a statistical software package that tested for increasing trend over dose groups with a one‑tailed Cochran‑Armitage trend test, followed by pairwise comparisons between each dosed group and the vehicle control group (ILS, 1990). In the presence of excess binomial variation, as detected by a binomial dispersion test, the binomial variance of the Cochran‑Armitage test was adjusted upward in proportion to the excess variation.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- no induction of micronuclei in peripheral blood erythrocytes
- Toxicity:
- yes
- Remarks:
- reduced mean terminal body weight in males (80 and 160 mg/kg bw) and females (40, 80, 160 mg/kg bw)
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
Any other information on results incl. tables
Results of the Micronucleus test, performed after 65 oral gavage doses in the 90-day repeated dose test are tabulated below. Harvesting time was 24 h after the last dose (cf. attached document: Annex E, table E3)
Dose (mg/kg/d) | MN-NCE/1000 NCE (mean±SEM) | Trend Test (P-value)(&) | % PCE | |
Males | ||||
0 | 1.15±0.21 | 2.18±0.08 | ||
10 | 1.20±0.17 | 0.442 | 2.38±0.14 | |
20 | 1.30±0.23 | 0.334 | 2.21±0.11 | |
40 | 1.00±0.17 | 0.676 | 1.94±0.06 | |
80 | 0.95±0.09 | 0.732 | 1.84±0.07 | |
160 | 0.95±0.15 | 0.732 | 2.15±0.23 | |
p=0.849 (§) |
||||
Females | ||||
0 | 0.85±0.13 | 2.09±0.08 | ||
10 | 0.80±0.11 | 0.569 | 2.11±0.08 | |
20 | 0.80±0.13 | 0.569 | 1.87±0.14 | |
40 | 0.95±0.12 | 0.369 | 1.84±0.12 | |
80 | 1.05±0.12 | 0.258 | 1.70±0.08 | |
160 | 0.80±0.15 | 0.569 | 1.78±0.11 | |
p=0.461 |
MN = micronucleated erythrocyte
NCE = normochromatic erythrocyte
PCE = polychromatic erythrocyte.
(&) = Pairwise comparison with the vehicle controls, significant at P=0.005 (ILS, 1990)
(§) = Significance of micronucleated NCEs/1,000 NCEs tested by the one-tailed trend test, significant at P=0.025 (ILS, 1990)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
Conclusion:
Formamide was negative in the mouse peripheral blood micronucleus assay when blood cells from male and female mice (10/dose/sex) of the 13-week repeated dose toxicity tests were examined at termination of the subchronic oral gavage study (NTP, 2008). The method is valid and comparable to OECD TG 474. The dose levels used were 0, 10, 20, 40, 80, and 160 mg/kg bw/day. The incidence of polychromatic erythrocytes was not significantly changed in males or females at any dose level, indicating the absence of formamide-induced bone marrow toxicity (NTP, 2008).
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