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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 December 1995 - 6 January 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (UK) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.7-3.1 kg
- Housing: Individually housed 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: not specified
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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye of treated animals served as concurrent control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL [equivalent to about 0.034 mL as calcium nitrite]
- Concentration (if solution): the test material was administered as supplied (34% aqueous solution of calcium nitrite) - Duration of treatment / exposure:
- Eyelids were gently held together for one second before releasing; no subsequent washing to remove test substance.
- Observation period (in vivo):
- 17 days. Examination of the eyes was made 1 hour and 1, 2, 3 (24, 48 and 72 hours), 4, 7, 14, 15 and 17 days after instillation.
- Number of animals or in vitro replicates:
- Two (one female, sex not specified in the other)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed
- Time after start of exposure: not applicable
SCORING SYSTEM: Ocular irritation was assessed using the prescribed numerical system:
Corneal opacity: No ulceration or opacity (0); scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible (1); easily discernable translucent areas, details of iris slightly obscured (2); nacreous areas, no details of iris visible, size of pupil barely discernible (3); opaque cornea, iris not discernible through the opacity (4).
Iris: normal (0); markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection (or combinations thereof), iris still reacting to light (sluggish reaction is positive) (1); no reaction to light, haemorrhage or gross destruction (or combinations thereof) (2).
Conjunctivae: blood vessels normal (0); some blood vessels hyperaemic (injected) (1); diffuse, crimson colour, individual vessels not easily discernible (2); diffuse beefy red (3).
Chemosis: no swelling (0); any swelling above normal (includes nictating membranes) (1); obvious swelling with partial eversion of lids (2); swelling with lids about half-closed (3); swelling with lids more than half-closed (4).
Any other lesion not covered by this scoring system was described.
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Reversibility:
- other: reversibility was not fully assessed due to humane sacrifice of the animals on Day 15 and 17 (after instillation of the test substance), respectively
- Remarks on result:
- other: An irritation index could not be determined because of the corrosive effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal effects were only apparent 2 weeks after instillation of the test material; reversibility was not fully assessed due to humane sacrifice of the animals on Day 15 and 17 (after instillation of the test substance), respectively
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridial effects were only apparent 2 weeks after instillation of the test material; reversibility was not fully assessed due to humane sacrifice of the animals on Day 15 and 17 (after instillation of the test substance), respectively
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- other: Conjunctival effects (redness) tended to worsen with time; reversibility was not fully assessed due to humane sacrifice of the animals on Day 15 and 17 (after instillation of the test substance), respectively
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: Conjunctival effects (chemosis) tended to worsen with time; reversibility was not fully assessed due to humane sacrifice of the animals on Day 15 and 17 (after instillation of the test substance), respectively
- Irritant / corrosive response data:
- Conjunctival redness and chemosis scores of 2-3 were observed in the first animal at all time points (scores of 1-3 were observed in the second animal throughout the observation period); in both cases the effects tended to worsen with time. Necrosis of the conjunctiva and nictating membrane was reported for both animals. Corneal and iridial effects were only apparent 2 weeks after instillation of the test material; these also worsened with time (during the third week of the observation period). Due to the severity of the effects the animals were killed on Day 15 and 17, respectively.
- Other effects:
- - Lesions and clinical observations:
No signs of ill health or toxicity were reported.
- Ophthalmoscopic findings: no data
- Histopathological findings: no data
- Effects of rinsing or washing: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, calcium nitrite (hydrate) (0.1 mL) produced severe irritation and corrosive effects following instillation into one eye of each of two rabbits.
- Executive summary:
In an EU Method B.5 study, to GLP, the ocular irritant potential of calcium nitrite (hydrate) was assessed in two New Zealand White rabbits. The test material (DCI) was available as a 34% aqueous solution of calcium nitrite. Initially, a 0.1 mL instillation of the test material was made to the eye of one female and both lids were gently closed for one second before releasing. The other eye remained untreated and acted as the control. Due to the severity of the observed effects only one other animal (sex unspecified) was treated.
Following instillation of the test material, conjunctival redness and chemosis were seen in both animals within one hour. In both cases, the effects tended to worsen as the study progressed, leading to the sacrifice of the animals on Day 15 and 17, respectively. Additional effects included necrosis of the conjunctiva and nictating membrane, along with corneal and iridial effects (only apparent 2 weeks after instillation) which also worsened with time. An irritation index could not be determined because of the corrosive effects. No clinical signs of toxicity were reported.
As the results were based on only two rabbits, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed tended to worsen with time and are not expected to be reversible.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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