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EC number: 214-185-2 | CAS number: 1111-78-0
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and OECD guideline 402
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium carbamate
- EC Number:
- 214-185-2
- EC Name:
- Ammonium carbamate
- Cas Number:
- 1111-78-0
- Molecular formula:
- CH3NO2.H3N
- IUPAC Name:
- ammonium carbamate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- The test substance was supplied by Smithers Viscient (SMV), LLC. As reported by SMV, the purity of the test substance was tested as 100% (composition of 43.6% as ammonia and 56.3% as carbon dioxide). The appropriate amount of test substance was ground to a fine powder and weighed into
tared weigh boats that were covered, labeled, and transported to the animal room for dosing. Sufficient deionized water (prepared on-site) was dispensed for moistening the test substance.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were approximately 8 weeks old at the initiation of dose administration.The albino rats utilized for this study were received in good health from Charles River Laboratories, Inc., Raleigh, NC. The rats were inspected by a qualified technician upon receipt, weighed and uniquely identified by a metal eartag displaying the animal number. The rats were acclimated to laboratory conditions for a minimum of 5 days. During this period, each animal was observed twice daily for mortality and changes in general appearance or behavior.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- On the day prior to dosing, the hair was removed from the backs and flanks of the rats using an electric clipper. Individual doses of the test substance were applied to the maximum area possible on the dorsal skin. Doses covered approximately 10% of the total body surface. Each dose was applied to the unabraded skin and overwrapped with gauze binders (<8 ply) that were secured with nonirritating tape. Upon completion of exposure, the bandages were removed and the sites were wiped with disposable paper towels moistened with tepid tap water.
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- DOSING:
One group of 5 male and 5 female rats were dermally administered a single dose (24 hour semi-occluded exposure) of ammonium carbamate at a dose level of 5000 mg/kg (5.0 g/kg). Individual doses were calculated based on body weights taken just prior to dosing.
MORTALITY:
The rats were observed at approximately 1, 2, and 4 hours post-application on study day 0 and twice daily, once in the morning and once in the afternoon, thereafter for 14 days.
CLINICAL OBSERVATIONS:
The rats were observed at approximately 1, 2, and 4 hours post-application on study day 0 and once daily thereafter for 14 days. Observations included, but were not limited to, evaluation for changes in appearance of skin and fur, eyes, mucous membranes, respiratory and circulatory systems, autonomic effects, and central nervous system effects.
DERMAL OBSERVATIONS:
The application sites were examined for erythema, edema (Draize scores), and other dermal findings beginning approximately 30-60 minutes after bandage removal and daily thereafter through study day 14. The areas of application were clipped free of hair on the day prior to dosing and as needed to facilitate accurate dermal observations.
BODY WEIGHTS:
Body weights were obtained and recorded on study days 0 (initiation), 7, and 14 (termination).
NECROPSY:
Upon termination, all rats were euthanized by carbon dioxide inhalation. The major organ systems of the cranial, thoracic, and abdominal cavities were examined for all animals.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical findings observed during the study.
- Gross pathology:
- At the scheduled necropsy, macroscopic findings consisted of scabbing at the application site for 1 male and 2 females.
- Other findings:
- Dermal findings noted during the study consisted of very slight (grade 1) to severe (grade 4) erythema, very slight (grade 1) to moderate (grade 3) edema, eschar, pinpoint scabbing, necrosis, scabbing within dose site, exfoliation, and desquamation. Erythema, eschar, and scabbing within dose site were still present for some rats at study termination
(study day 14)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, the LD50 of ammonium carbamate was greater than 5000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats. Classification according to Regulation (EC) No 1272/2008 is therefore not required.
- Executive summary:
The objectives of this study were to determine the acute dermal median lethal dose, evaluate potential systemic toxicity, and evaluate the local irritative effects of the ammonium carbamate when applied once to the skin of albino rats. The study was conducted according to GLP and OECD guideline 402.
The test substance, ammonium carbamate, was administered once dermally for a 24-hour period under semi-occlusive dressing to Crl:CD(SD) albino rats for the determination of a median lethal dosage (LD50). The test substance was administered to 1 group of 5 male and 5 female rats at a dose level of 5000 mg/kg (5.0 g/kg).
Mortality, clinical observations, dermal findings (Draize, 1965; Appendix C), and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.
There were no deaths, remarkable body weight changes, or clinical findings. Dermal findings noted during the study consisted of very slight to severe erythema, very slight to moderate edema, eschar, pinpoint scabbing, necrosis, scabbing within dose site, exfoliation, and desquamation. Scabbing at the application site was noted for 1 male and 2 females at the scheduled necropsy.
Based on the results of this study, the LD50 of ammonium carbamate was greater than 5000 mg/kg when administered once for 24 hours to the clipped, unabraded skin of male and female albino rats. Classification according to Regulation (EC) No 1272/2008 is therefore not required.
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