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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 December 1995 - 14 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 29.12.1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An in vivo skin sensitisation study by the LLNA method does not need to be conducted because adequate data from an existing guinea pig maximisation test are available.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Microbiological status of animals, when known: no data
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 268-327 g
- Housing: Groups of five in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): Vitamin C enriched guinea-pig diet FD2 ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 13 days
- Indication of any skin lesions: Animals were described only as "healthy"
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: water for irrigation (intradermal induction); distilled water (topical induction)
- Concentration / amount:
- Intradermal induction: 1% DCI v/v
Topical induction: 10% DCI v/v - Day(s)/duration:
- Injection on day 1 followed by a 48-hour topical induction 1 week later
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 2.5 and 5% DCI v/v
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 test and 5 control animals.
- Details on study design:
- RANGE FINDING TESTS: The intradermal and topical irritancy of a range of dilutions of the test substance was investigated to identify where possible a) test substance concentrations that would produce irritation suitable for the induction phase of the main study, and b) a maximum non-irritant topical concentration for the challenge phase. Animals were pretreated with an intradermal injection of Freund's complete adjuvant/water (50:50). For the intradermal injections, 2 guinea pigs were used and 8 concentrations of test material were tested on each animal; 4 topical concentrations were tested on each of 2 additional animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal (3 injections) followed 1 week later by 1 topical
- Exposure period: Over the course of a 9-day period
- Test groups: Intradermal injections: 1) Freund’s Complete Adjuvant (FCA) diluted with an equal volume of water for irrigation. 2) The test article, diluted to 1% with water for irrigation. 3) The test article diluted to 1% in a 50:50 (v/v) mixture of FCA and water for irrigation. Topical application: A patch saturated with 0.4 mL of DCI (diluted to 10% v/v in distilled water) was placed on the clipped skin of the test animals for 48 hours. The patch was covered by a length of impermeable plastic adhesive tape, secured with an elastic adhesive bandage wound round the torso of each animal and fixed with impervious plastic adhesive tape.
- Control group: Similarly treated to the test animals with the exception that the test substance was omitted was the intradermal injections and topical application.
- Site: An area of dorsal skin (clipped free of hair prior to both inductions) from the scapular region (40 mm x 60 mm).
- Frequency of applications: Injection at three sites on day 1 and topical application on day 8
- Duration: Topical application was for 48 hours (occluded)
- Concentrations: 1% for intradermal injections (selected since this was the highest concentration that caused irritation but did not adversely affect the animals) and 10% for topical application (selected as this was the highest concentration that produced some irritation but did not adversely affect the animals).
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: Patches (20 mm x 20 mm) saturated with DCI at respective concentrations of 2.5 and 5% v/v were applied to the posterior and anterior sites on the left flank of each animal. The patches were sealed under strips of impermeable plastic adhesive tape, covered with an elastic adhesive bandage wound round the trunk of each animal and secured with impervious plastic adhesive tape.
- Control group: Similarly treated to the test animals (challenge with DCI)
- Site: An area on the left flank of each animal was clipped and shaved.
- Concentrations: 2.5 and 5% for topical challenge (selected as 5% was the highest concentration that did not produce irritation).
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of the challenge patches.
OTHER: All animals were observed daily for signs of ill health or toxicity. Body weights of individual animals were measured on day 1 and on the final day of observation following the challenge application.
Dermal reactions following the induction and challenge phases of the study were assessed using the following system:
Erythema and eschar formation: No erythema (0); slight erythema (1); well-defined erythema (2); moderate erythema (3); severe erythema (beet redness) to slight eschar formation (injuries in depth) (4).
Oedema formation: No oedema (0); slight oedema (1); well-defined 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).
The diameter (mm) of the dermal response at the intradermal injection sites was recorded in the preliminary study only to assist in the choice of concentrations for the main study. Any other lesion not covered by this scoring system was described. - Challenge controls:
- Similarly treated as test group
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (the sensitivity of the guinea-pig strain is checked periodically at the testing facility using this known sensitiser)
Results and discussion
- Positive control results:
- A selection of tests using the known sensitiser hexyl cinnamic aldehyde (positive control) were conducted at the testing facility in the years prior to this investigation. All seven studies utilised 10 test animals (with 5 or 10 control animals). In one study, 80% of the animals of the test group had positive skin reactions following treatment with 50% (and as supplied) hexyl cinnamic aldehyde in aqueous solution; a 90% positive response was seen in two studies and a further four studies showed a 100% positive response.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% DCI v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Slight erythema was observed in one animal
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Necrotic edge was observed in one animal; dryness and sloughing of the epidermis was seen in the same animal and in two others
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% DCI v/v
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- Necrotic edge and dryness/sloughing of the epidermis were observed in three and six animals, respectively; three animals showed slight erythema (persisted at the 72-hr time point in only one of these animals)
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2.5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Necrotic edge was observed in one animal; dryness and sloughing of the epidermis was seen in another
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% DCI v/v
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Necrotic edge and dryness/sloughing of the epidermis were observed in three and four animals, respectively; one animal showed slight erythema
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5 and 5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5 and 5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 2.5 and 5% DCI v/v
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: Summary of positive control data (results for seven studies)
- Group:
- positive control
- Dose level:
- As supplied (and 50%)
- No. with + reactions:
- 66
- Total no. in group:
- 70
Any other information on results incl. tables
Slight irritation reported at induction with test material.
No signs of ill health or toxicity were reported, and growth was recorded for all guinea-pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guideline study, to GLP, calcium nitrite (hydrate) was not sensitising to guinea pigs dermally challenged with the test compound at up to a concentration of 5% following a two-stage induction with 1% by intradermal injection and 10% by topical application.
- Executive summary:
The skin sensitisation potential of calcium nitrite (hydrate) was assessed in an EU Method B.6 guinea pig maximisation test (GPMT) using groups of 10 test and 5 control animals. The test material (DCI) was available as a 34% aqueous solution of calcium nitrite.
Male albino guinea pigs were induced, on clipped skin, with a 1% aqueous solution of the test material by intradermal injection (in combination with a preparation of Freund’s complete adjuvant), followed one week later by a second induction by skin application of a 10% aqueous solution of the test substance under a 48-hr occlusive patch. (These concentrations (1 and 10%) were the highest that caused irritation, but not adverse systemic effects, in the preliminary test.) Control animals were similarly treated but without the test substance. Two weeks after the second (dermal) induction, a challenge concentration of 2.5 and 5% of the test material were applied under 24-hr occlusive patches to both test and control animals. (These dermal challenge concentrations were selected following the results of a preliminary study, in which 5% is considered the highest non-irritant concentration). Dermal reactions were evaluated 24, 48 and 72 hours after removal of the challenge patches. No clinical signs of toxicity were reported.
No positive skin sensitisation reactions were observed at any time point following dermal challenge at a concentration of 2.5% test material. One test animal displayed slight transient erythema upon examination 24 hr after removal of the 5% challenge patch, persisting to the 48-hr time point. An additional two animals showed similar effects at this time point, though these observations persisted at the 72-hr time point in only a single animal. Necrotic edge was apparent in three animals at the 48 and 72-hr time points. Calcium nitrite (hydrate) produced no evidence of skin sensitisation in eight of the ten test animals in this GPMT, producing an inconclusive response in one animal and a positive response in another. Overall, the test material is not considered to be a skin sensitiser in this assay.
Based on the results of this study, calcium nitrite does not warrant classification for skin sensitisation, according to EU CLP criteria (EC 1272/2008).
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