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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of the developmental toxicity of formamide in Sprague-Dawley (CD) rats.
- Author:
- George JD, Price CJ, Marr MC, Myers CB and Jahnke GD
- Year:
- 2 000
- Bibliographic source:
- Toxicol. Sci. 57, 284-291.
- Reference Type:
- publication
- Title:
- Developmental toxicity evaluation of formamide administered to rats on gestational days (gd) 6 through 19.
- Author:
- Price CJ, Marr MC, Myers CB and Jahnke GD
- Year:
- 1 999
- Bibliographic source:
- Teratology 59 (6), 412; abstract no. P49.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: in accordance with US FDA, CFR 56 FR 12300 (March 21, 1994)
- GLP compliance:
- yes
- Limit test:
- no
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): FORM
- Analytical purity: purity >99%
- source: Aldrich Chemical
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Weight at study initiation: 222-273 g on GD0
- Housing: singly
- Diet: Purina Certified Rodent Chow® (#5002; PMI, St. Louis, MO) and tap water were available ad libitum
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 48-59%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Formamide was dissolved in water.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dose fonnu1ations were stored under refrigeration and administered within the period of proven stability (35 days). One set of dose formulations were prepared, and aliquots were submitted for verification of concentration before and after the period of use. Measured concentrations were within 97.9-100.3% of the theoretical concentration (NTP (1998), Tables 4 and A4-1).
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Proof of pregnancy: sperm in vaginal smear; referred to asday 0 of pregnancy (GD0) - Duration of treatment / exposure:
- days 6 through 19 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- entire gestation from GD0 to GD 20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 100, 200 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on results of a preceding range finding study
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes / No / No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes / No / No data
- Sacrifice on gestation day #
- Organs examined:
OTHER:
CAGE SIDE OBSERVATIONS: Yes / No / No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: body weight (g) was recorded on the mornings of gd 0, 6 through 20, and immediately following sacrifice
on gd 20.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes (no feeding study)
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: uterus, liver
-other: the body, liver, and gravid uterus of each timed-mated female were weighed. Thoracic and abdominal cavities were examined. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- Statistical evaluation was extensive; cf. attached publication for details
- Indices:
- No
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Statistically significantly reduced maternal body weigt gain during gestation (GD6 - GD20). The maternal body weight corrected for the gravid uterine weight was not changed. Clinical signs of toxicity or mortality were not seen.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Statistically significantly reduced fetal body weights at 100 and 200 mg/kg bw/day.Number of fetuses/litter and viability were not affeted. the incidence of malformations or variations was not increased at any doose.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
MATERNAL TOXICITY:
Maternal food and water intake were not different from control.
There were no substance-related clinical signs of toxicity.
No maternal deaths or morbidity occurred.
Maternal body weight exhibited a dose-related decreasing trend; reductions were significant at 200 mg/kg bw/d on gd 18 to 20.
Body weight gain was significantly reduced at the top dose during gestation days 6 -20.
However, maternal gestational weight gain was not affected when corrected for gravid uterine weight.
Mean uterine weight wasdecreased in a dose-related manner (-0, -6, and -13%,
respectively; statistically significant at 200 mg/kg bw/d).
Maternal liver weight was not affected.
Overall, maternal toxicity was minimal, a NOAEL of 100 mg/kg
bw/d was established, based on a decrease in gravid uterine
weight at the top dose.
FETAL TOXICITY:
Treatment-related effects were limited to a decreasing trend in the average fetal body weight (-0, -7, and -15%), with
significant reductions at >= 100 mg/kg bw/d).
[Note: In the 100-mg group, one animal was treated as an outlier because of comparatively high fetal weights (p. 15).
The reduction in fetal body weight reduction at this dose level became statistically significant after removal of this
animal from the study]
All other parameters failed to show any difference from control values: Number of corpora lutea/dam ranged from 15.6 to 16.1 and largely corresponded the number of implantations
in all groups, with preimplantation losses from about 4 to 6.5% throughout. Mean percentage of resorptions ranged from
1.4 and 1.6 (control and low-dose group, resp.) to 3.0 and 4.1% in the mid- and high-dose group with no statistical
significance for the latter apparent increases.
Late fetal deaths were absent in all groups.
Sex ratios were not affected by exposure.
No statistical significant differences were observed in the incidences of fetal morphological anomalies, the overall
incidences were approximately 1.3 (control), 2.2, 0.6, and 1.3% for the respective groups. A NOAEL of 50 mg/kg bw/d was established, based on decreases in fetal body weight.
Applicant's summary and conclusion
- Conclusions:
- Fetal toxicity (decrease in fetal weight) was noted in rats at a dose (100 mg/kg bw/day) which was not evidently toxic to the dams.
There was no evidence of an increase in structural anomalies related to formamide at 50, 100, or 200 mg/kg bw. - Executive summary:
In a developmental toxicity study conducted similar to OECD guideline 414 and under GLP conditions, time-pregnant Sprague-Dawley (25 females/dose) were dosed by gavage with formamide (0, 50, 100 or 200 mg/kgbwandday; dose selection based on results of a range finding study) on GD 6 through 19. Maternal toxicity was low and limited to statistically significant body weight gain reduction during gestation (GD 6-19), reduced body weight on GD 18-20, and reduced gravid uterine weight at 200 mg/kgbwand day. The body weight corrected for the gravid uterus weight was not affected and comparable between all groups. Liver weight (absolute and relative) was unaffected by treatment with formamide.
The average male and female fetal weight was statistically significantly reduced at 100 and 200 mg/kgbwand day. The number of fetuses per litter and fetal viability were not affected. The sex distribution was not changed. The incidence of external, skeletal or visceral malformations and variations was not increased at any dose. In this study, the ratconceptuswas more sensitive than the adult to the adverse effects of formamide administered orally throughout the embryo/fetal period of gestation.
Overall, the maternal toxicity NOAEL was 100 mg/kg bw/day in this study, based on a decrease in gravid uterine weight at the top dose. The developmental NOAEL was 50 mg/kg bw/d was established, based on decreases in fetal body weight. Teratogenicity was not seen, the NOAEL was therefore 200 mg/kg bw/day (NTP, 1998).
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