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EC number: 212-751-3 | CAS number: 866-81-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Apr - 27 Apr 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministère de L'Économie de L'Industrie et de L'Emploi
Test material
- Reference substance name:
- Tricobalt dicitrate
- EC Number:
- 212-751-3
- EC Name:
- Tricobalt dicitrate
- Cas Number:
- 866-81-9
- Molecular formula:
- C6H8O7.3/2Co
- IUPAC Name:
- tricobalt dicitrate
- Details on test material:
- - Name of test material (as cited in study report): Cobalt Citrate
- CAS No.: 866-81-9
- Date received: 23 March 2010
- Physical state / appearance: pink powder
- Analytical purity: 99%
- Lot/batch No.: 10142709
- Expiration date of the lot/batch: 01 April 2011
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino New Zealand
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste -F40260 Linxe)
- Age at study initiation: 12 or 13 weeks
- Weight at study initiation: between 2.30 kg and 3.25 kg
- Housing: individual box
- Diet (e.g. ad libitum): SDS - C15 ad libitum
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (07.00 to 19.00) and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The second eye of an animal remained untreated serving as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- the eye of one rabbit was unwashed, the eyes of two animals were rinsed (after one hour, as test item has not been removed)
- Observation period (in vivo):
- Ocular examinations were performed 1 hour, 24, 48 and 72 hours following treatment up to 21 days in order to determine the reversibility
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed (one rabbit)
- Washing (if done): rinsed (two animals)
- Time after start of exposure: one hour
SCORING SYSTEM: Chemosis 0 - 4; Discharge 0 - 3, Redness 0 - 3, Iris 0-2, Cornea: degree of opacity 0 - 4 and Cornea: extent of opacity 0 - 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: relevant for classification
- Irritation parameter:
- other: Redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- other: Redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Table1: Individual and mean scores of conjunctivae, iris and cornea
Animal No. |
Time after treatment |
Conjunctivae Chemosis Redness |
Iris Lesion |
Cornea Opacity |
|
A0115 |
24 hours |
1 |
2 |
1 |
0 |
48 hours |
1 |
2 |
0 |
0 |
|
72 hours |
1 |
2 |
0 |
0 |
|
Total |
3 |
6 |
1 |
0 |
|
Mean |
1.0 |
2.0 |
0.3 |
0.0 |
|
A0110 |
24 hours |
2 |
2 |
0 |
1 |
48 hours |
1 |
2 |
0 |
0 |
|
72 hours |
1 |
2 |
0 |
0 |
|
Total |
4 |
6 |
0 |
1 |
|
Mean |
1.3 |
2.0 |
0.0 |
0.3 |
|
A0117 |
24 hours |
2 |
2 |
0 |
0 |
48 hours |
2 |
2 |
0 |
0 |
|
72 hours |
2 |
2 |
0 |
0 |
|
Total |
6 |
6 |
0 |
0 |
|
Mean |
2.0 |
2.0 |
0.0 |
0.0 |
|
The ocular reactions observed during the study have been slight to important and partially reversible: - at the conjunctivae level: a moderate redness associated with a moderate to important chemosis, noted 1 hour after the test item instillation. The redness was totally reversible in two animals between day 8 and day 9 and remained in the last one on day 21 (last day of the test, slight intensity). The chemosis was totally reversible between day 7 and day 10, - at the corneal level: a slight corneal opacity, noted 24 hours after the test item instillation in one animal and totally reversible on day 2, - at the iris level: a congestion, noted 24 hours after the test item instillation in one animal and totally reversible on day 2. In one animal, the presence of a white spot on the nictitating membrane was noted on day 2 and was associated with the presence of a white spot on the lower eyelid on day 6. These reactions remained on day 21 (last day of the test). In another animal, the presence of a white spot on the nictitating membrane was noted between day 2 and day 8 and on day 2 on the lower eyelid. This reaction was totally reversible on day 9.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information highly irritating
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