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EC number: 237-424-2 | CAS number: 13780-06-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-15 December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Good quality study, conducted to GLP. The test material was a 34% solution of hydrated calcium nitrite.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29.12.92
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Calcium nitrite
- EC Number:
- 237-424-2
- EC Name:
- Calcium nitrite
- Cas Number:
- 13780-06-8
- Molecular formula:
- Ca.2HNO2
- IUPAC Name:
- calcium nitrite
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.4-3.2 kg
- Housing: house individually in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Stanrab (P) standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: "all animals were acclimatised to the experimental environment", but no details on the acclimation period given
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL [equivalent to about 0.17 mL as calcium nitrite]
- Concentration (if solution): the test material was applied as supplied (34% aqueous solution of calcium nitrite) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after exposure
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: 25 mm x 25 mm from the dorso-lumbar region of each rabbit
- % coverage: no data
- Type of wrap if used: The gauze pad was covered by an elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30-40°C) (the treated area was subsequently blotted dry)
- Time after start of exposure: 4 hours (upon removal of dressing and gauze pad)
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): On the day of treatment (approximately 60 minutes after removal of the dressings) and on the subsequent three days (equivalent to 24, 48 and 72 hours after exposure)
SCORING SYSTEM:
Local dermal irritation was assessed using the following system:
Erythema and eschar formation: No erythema (0); slight erythema (1); well-defined erythema (2); moderate to severe erythema (3); severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading (4).
Oedema formation: No oedema (0); very slight oedema (barely perceptible) (1); slight oedema (edges of area well-defined by definite raising) (2); moderate oedema (raised approximately 1 mm) (3); severe oedema (raised by more than 1 mm and extending beyond the exposure area) (4).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of erythema was seen at the 24, 48 and 72-hour time points.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No evidence of oedema was seen at the 24, 48 and 72-hour time points.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: No evidence of irritation was seen at the 24, 48 and 72-hour time points.
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Transient very slight erythema was observed in one animal 60 minutes after removal of the dressing (no evidence of irritation was apparent at the subsequent observation time points). No dermal response was seen in the remaining two animals.
- Other effects:
- - Other adverse local effects:
no data
- Other adverse systemic effects: No signs of ill health or toxicity were reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, calcium nitrite (hydrate) (0.5 mL) was applied (4-hr, semi-occluded) to the clipped skin of three male rabbits. Transient very slight irritation was reported in a single animal at the 1 hr observation point. No other irritation was reported.
- Executive summary:
In an EU Method B.4 study, the skin irritant potential of calcium nitrite (hydrate) was assessed in three male New Zealand White rabbits. The test material (DCI) was available as a 34% aqueous solution of calcium nitrite. A 0.5 mL semi-occlusive application of the test material was made to the clipped skin for 4 hours. Following removal of the dressing, the treated sites were washed and subsequently assessed for evidence of erythema (and eschar) formation and oedema formation after approximately 1 hour, and again 24, 48 and 72 hours later.
One rabbit displayed transient very slight erythema one hour after removal of the dressing, though no evidence of irritation was apparent at the subsequent observation time points. No dermal response was seen in the remaining two animals. The overall irritation score was 0 (out of 8). No clinical signs of toxicity were reported.
Based on the results of this study, no classification for skin irritation is required under EU CLP criteria (EC 1272/2008).
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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