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EC number: 235-715-9 | CAS number: 12607-70-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 19 - 26, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [carbonato(2-)]tetrahydroxytrinickel
- EC Number:
- 235-715-9
- EC Name:
- [carbonato(2-)]tetrahydroxytrinickel
- Cas Number:
- 12607-70-4
- Molecular formula:
- Ni3(OH)4CO3
- IUPAC Name:
- trinickel monocarbonate tetrahydroxide
- Details on test material:
- - Name of test material (as cited in study report): Nickel hydroxycarbonate
- Physical state: green powder
- Analytical purity: 100%
- Lot/batch No.: Code #N109A-PTL
- Soluble in water. 34.5 mg/L (pH 6), 7.1 mg/L (pH 8).
- Stability: Test substance was expected to be stable for the duration of testing
- Storage condition of test material: kept closed under nitrogen
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC on August 13, 2008.
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 61-84%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: August 19 - 26, 2008
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- One-tenth of a milliliter (0.06 grams) of the test substance was then instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control.
VEHICLE: none, sample was instilled as received. - Duration of treatment / exposure:
- 1, 24, 48, and 72 hours and at 4 and 7 days post-instillation.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours and at 4 and 7 days post-instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none reported
SCORING SYSTEM: Scored using criteria described in Draize et al., 1944; score classified by Maximum Mean Test Score described in Kay and Calandra, 1962.
TOOL USED TO ASSESS SCORE: using a high-intensity, white light (Maglite).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: over 7 days
- Score:
- 22
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- other: 4 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3401
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- other: 4 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3402
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- other: 4 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3403
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3401
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3401
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3401
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3401
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3402
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3402
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3402
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3402
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- other: 4 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 3403
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3401
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3401
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3401
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3401
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3402
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3402
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3402
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3402
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3403
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3403
- Time point:
- 24/48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3403
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3403
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 3403
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3401
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3401
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3401
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3401
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3402
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3402
- Time point:
- 24/48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3402
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3402
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3402
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3403
- Time point:
- other: 1 hr
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3403
- Time point:
- 24/48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3403
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3403
- Time point:
- other: 4 d
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3403
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- From 1 to 24 hours after test substance instillation, all three treated eyes exhibited corneal opacity, iritis and 'positive' conjunctivitis. The overall incidence and severity of irritation decreased there after. All animals were free of ocular irritation by Day 7 (study termination). The Maximum Mean Total Score of nickel hydroxycarbonate is 22.0.
- Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Kay and Calandra. Interpretation of eye irritation tests. J. Soc. Cos. Chem. 1962; 13:281-289.
- Conclusions:
- Under the conditions of this study, the test substance is classified as moderately irritating to the eye.
- Executive summary:
Eurofins Product Safety Laboratory (EPSL 2008) conducted a primary eye irritation test with rabbits to assess the potential for nickel hydroxycarbonate to cause irritation from a single instillation in the eye (carried out according to OECD Procedure 324 guidelines and using GLP standards). The right eyes of three healthy, female white rabbits were treated with 0.1 milliliter (0.06 g) of nickel hydroxycarbonate via direct instillation. The left eyes served as controls and were not treated. The Draize method was used to assess eye irritation (iritis, corneal opacity, conjunctivitis, lesions) at 1, 24, 48 and 72 hours, as well as 4 and 7 days post-instillation. The
treated eyes were further evaluated using fluorescein dye at 24 hours and as necessary to determine effect reversal and examine the corneas. At least once per day, the animals were observed for signs of behavioral changes and gross toxicity, including gross evaluation of eyes; mucous membranes; central and autonomic nervous systems, as well as circulatory and respiratory systems; fur; skin; and somatomotor activity. Specifically, the authors focused on diarrhea, salivation, coma, convulsions, and tremors.
Within 1 hour after instillation, all three animals exhibited iritis, corneal opacity and conjunctivitis. By 72 hours, no corneal opacity was observed. The conjunctivitis was resolved by day 4, and the iritis was no longer evident by day 7. The mean irritation scores for all animals combined decreased over time and were as follows: 1 and 24 hours (22.0), 48 hours (20.3), 72 hours (10.7), day 4 (8.7), day 7 (0.0). Other than the observed eye irritation, the animals appeared healthy and active with no other signs of toxicity or behavioral effects. Based on the time interval with the highest mean irritation score (22.0 at 1 and 24 hours), nickel hydroxycarbonate was classified as moderately irritating to the eye. STUDY RATED BY AN INDEPENDENT REVIEWER
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