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EC number: 233-786-0 | CAS number: 10361-29-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004.08.02 - 2004.08.23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordance with OECD, EC, OPPTS and MAFF Guidelines with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Testing Guideline of 12 Nousan No.8147
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST SPECIES
Strain: New Zealand White A1077 INRA (SPF)
Origin: Centre Lago S.A., 01540 Vonnas, France
Number: 3
Sex: Males/Females
Identification of animals: Ear tattoo
Age at study initiation: about 4 months
Weight at study initiation: 3.10-3.24kg
TEST CONDITIONS
Temperature: 20-24ºC
Relative humidity: 30-70%
Photoperiod: 12h light(6am-6pm)/12h dar(6pm-6am)
Housing: Stainless steel wire mesh cages with grating, floorarea: 3000 CM2, single housing.
Diet: Kliba-Labordiät (Kaninchen & Meerschweinchen- haltung "GLP"), Provimni Kliba SA, Kaiseraugst, Basel, Switzerland (about 130g/animal/day)
Water: Tap water ad libitum
Acclimation period: yes: 5 days prior to start of study. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL bulk volume (about 66 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 1h
- Observation period (in vivo):
- Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- CONDUCT OF THE STUDY
Body weight determination: Just before application of the test substance and after the last reading.
Route of application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid.
Application volume: 0.1 mL bulk volume (about 66 mg of the comminuted test substance)
Rinsing of the eye: About 1 hour after application of the solid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Negative control: Untreated left eye
Readings: Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Illumination used tor reading: Daylight tubes "Lumilux" (L-58W/860 PLUS ECO 25x1, Osram, Germany)
Check tor dead or moribund animais: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
SCORING SYSTEM
The evaluation of eye irritation is performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions. - Irritation parameter:
- cornea opacity score
- Remarks:
- (Opacity)
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 0.8
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the described ocular reactions as weil as the average score tor irritation, Ammroniumcarbonat does not show an eye irritation potential under the test conditions chosen.
- Executive summary:
The aim of the study was to assess the eye irritation potential of the test substance tor product safety and regulatory purposes.
All available Information on toxicological and physico-chemical properties of the test substance including considerations concerning structure-activity-relationships did not indicate severe eye irritating properties. Therefore the eye irritation potential was tested in vivo in the rabbit.
The potential of Ammoniumcarbonat to cause damage to the conjunctiva, iris or corneawas assessed by a single ocular application of 0.1 mL bulk volume (about 66 mg) of the test substance to one eye of three White New Zealand rabbits.
Slight corneal opacity, moderate conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed in the animais during the course of the study. In addition discharge of blood, soleral vesseis injected in a circumscribed area or circular and marginal vascularization of the cornea in a circumscribed area were noted during the observation period.
Considering the described ocular reactions as weIl as the average score tor Irritation, Ammnoniumcarbonat does not show an eye irritation potential under the test conditions chosen.
Reference
The ocular reactions were reversible in 2 animals within 7 days and in 1 animal within 14 days after application.
In addition discharge of blood, scleral vessels injected in a circumscribed area or circular and marginal vascularization of the cornea in a circumscribed area were noted during the observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The mean relative viability of test item Ammonium carbonate after 15 minutes exposure and 42 hours post incubation period was 115% (SD± 8.89). According to EU classification, the substance is considered to be non-irritant since the mean tissue viability % was >50.
Justification for classification or non-classification
The substance is not classified as eye irritant.
The substance is not classified as skin irritant.
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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