Registration Dossier
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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Dose-range-finding teratology study; only 6 dams per dose level
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Principles of method if other than guideline:
- Dose-range-finding teratology study in rats
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- C H2 O
- IUPAC Name:
- formaldehyde
- Test material form:
- gas
Constituent 1
- Specific details on test material used for the study:
- Paraformaldehyde
Batch No. 732540 from Fischer Scientific Co.
The purity of is at least 95%, with the majority of the remaining 5% being water
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- Formaldehyde gas was generated by depolymerizing paraformaldehyde at constant temperature (80°C)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Daily samples were analyzed by the chromotropic acid method
- Details on mating procedure:
- Mating was achieved by placing 1 female with 1 male overnight; mating determined by the presence of spermatozoa in the vaginal lavage; the day
of positive identification of spermatozoa termed day 0 of gestation. - Duration of treatment / exposure:
- day 6 to day 15 of gestation
- Frequency of treatment:
- once daily; 6 hours/day
- Duration of test:
- Sacrifice and caesarean section day 20 of gestation
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- Clinical signs
Mortality
Body weight
Food consumption
Necropsy - Ovaries and uterine content:
- corpora lutea, live and dead fetuses, early, middle and late resorptions and the pre- and post-implantation losses
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 10 ppm (nominal)
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- necropsy findings
- Dose descriptor:
- NOAEC
- Effect level:
- 5 ppm (nominal)
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: red nasal discharge, red nasal discharge, decreased body weight, reduced food consumption
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 16 ppm (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: highest dose level tested; limited parameters measured
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In a pilot study for range-finding no developmental effects were detected in an inhalation study in rats at the high dose level of 16 ppm but maternal toxicity at >= 10 ppm (NOAEC 5 ppm).
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