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EC number: 800-777-3 | CAS number: 1351378-24-9
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 Jul - 24 Jul 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (according to OECD Guideline 405 adopted 24th April 2002 (no anesthetics or analgesics were used)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 405 (Acute Eye Irritation / Corrosion) (adopted 24 April 2002)
- Deviations:
- yes
- Remarks:
- no information on clinical signs or pain/distress are given in the test report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on clinical signs or pain/distress are given in the test report
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
Test material
- Reference substance name:
- dioxomolybdenum; oxonickel; trioxotungsten
- EC Number:
- 800-777-3
- Cas Number:
- 1351378-24-9
- Molecular formula:
- (Ni)z(Mo)x(W)yO(13 – 20)x
- IUPAC Name:
- dioxomolybdenum; oxonickel; trioxotungsten
- Test material form:
- other: grained solid
- Details on test material:
- - Name of test material (as cited in study report): 2-Butenedioic acid (2Z)-, reaction products with ammonium di-µ3-hydroxyhexacosa-µ-oxododecaoxododecatungstate(6-) (6:1), ammonium octa-µ-oxodi-µ3-oxo-µ4-oxododecaoxoheptamolybdate(6-) (6:1), nickel(2+) nitrate (1:2) and nickel(2+) sulfate (1:1)
- Physical state: green, grained solid
- Analytical purity: > 99%
- Lot/batch No.: 19266-184-1
- Expiration date of the lot/batch: May 2018
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 12 - 13 weeks
- Weight during study period: 2.66 - 3.78 kg
- Housing: individual
- Diet: SDS - C15, ad libitum
- Water: tap-water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 h (remaining test item was rinsed with physiological saline 1 h after instillation in all animals)
- Observation period (in vivo):
- 14 days
Reading time points: 1, 24, 48, 72 h and on Day 7 and 14 - Number of animals or in vitro replicates:
- 1 female (initial test)
2 females (confirmatory test) - Details on study design:
- SCORING SYSTEM: similar to Draize scoring system, supplemented with scoring for discharge and extent of opacity
Discharge:
No discharge - 0
Slight discharge (normal slight secretions in the inner corner to be taken into account) -2
Discharge with moistening of the eyelids and neighbouring hairs - 2
Discharge with moistening of the eyelids and large areas around the eye -3
Cornea: Extent of opacity:
Opaque area present but covering 1/4 or less - 1
Between 1/4 or 1/2 - 2
Between 1/2 and 3/4 - 3
Between 3/4 and the entire surface - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- The test item induced slight to severe eye reactions:
- slight to moderate corneal opacity in 3/3 animals noted 24 h after instillation which was fully reversible within 2 days.
- congestion of the iris in 1/3 animals noted 24 h after instillation which was fully reversible within 2 days.
- moderate to severe redness of the conjunctivae in 3/3 animals noted after 24 h instillation which was fully reversible latest within 14 days.
- slight to severe chemosis in 3/3 animals noted 24 h after instillation which was fully reversible latest within 14 days.
Further, white coloration of the inferior conjunctiva was noted in animal#1 between Day 2 and Day 7. - Other effects:
- No information on clinical signs or pain/distress are reported.
Any other information on results incl. tables
Table 1. Eye reactions after instillation.
Rabbit #
1
2
3
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
24 |
2 |
3 |
0 |
1 |
||||||
48 |
2 |
1 |
0 |
0 |
||||||
72 |
2 |
1 |
0 |
0 |
||||||
average |
2 |
1.7 |
0.0 |
0.3 |
Time to reversion |
14 days |
7 days |
0 |
2 days |
|
24 |
3 |
4 |
1 |
2 |
||||||
48 |
3 |
3 |
0 |
0 |
||||||
72 |
3 |
2 |
0 |
0 |
||||||
average |
3 |
3 |
0.3 |
0.7 |
Time to reversion |
14 days |
14 days |
2 days |
2 days |
|
24 |
2 |
1 |
0 |
1 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
1 |
0 |
0 |
0 |
||||||
average |
1.3 |
0.3 |
0.0 |
0.3 |
Time to reversion |
2 days |
7 days |
0 |
2 days |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye irrit 2, H319
DSD: not classified
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