Registration Dossier
Registration Dossier
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EC number: 407-130-0 | CAS number: 65232-89-5 BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30.08.1988 - 27.09.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Divanadyl pyrophosphate
- EC Number:
- 407-130-0
- EC Name:
- Divanadyl pyrophosphate
- Cas Number:
- 65232-89-5
- Molecular formula:
- (VO)2P2O7
- IUPAC Name:
- (phosphonooxy)phosphonic acid dihydrate vanadium
- Details on test material:
- Physical state: greyish-green powder
- Analytical purity: 100%
- Lot/batch No.: 3883559 A
- Storage condition of test material: 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: Hazleton-Dutchland Inc., Denver, Pennsylvania.
- Age at study initiation: young adults (at least 8 weeks old)
- Weight at study initiation: no data
- Housing: individually
- Diet: Lab Rabbit Chow HF (Purina #5326), 125 g/day while on test.
- Water: tap water, ad libitum.
- Acclimation period: 56 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 cm3 - Duration of treatment / exposure:
- Single application, eyes were not washed after treatment.
- Observation period (in vivo):
- 28 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No wash was performed after application of the material. Approximately 24 h after application, the treated eyes were rinsed to remove any residual test application.
SCORING SYSTEM: draize score
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 28 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 28 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Score:
- 2.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 days
Any other information on results incl. tables
Findings animals 1/2/3/4/5/6 (undiluted test substance):
| Time | Opacity | Iritis | Conjunctival Erythema | Conjunctival Chemosis | ||||||||||
| 1 h | +/+/+/0/+/+ | +/0/+/+/0/+ | 2/1/1/1/1/1 | 0/0/0/0/0/1 | ||||||||||
| 24 h | 2/1/2/2/2/2 | 1/1/1/1/1/1 | 3/3/3/3/3/3 | 3/3/3/3/3/3 | ||||||||||
| 48 h | 2/+/2/1/2/2 |
2/1/1/1/1/1 | 3/3/3/2/2/3 | 3/2/3/2/2/2 | ||||||||||
| 72 h | 2/+/1/+/+/+ | 2/1/1/1/+/1 | 3/2/3/2/2/2 | 2/2/2/2/2/2 | ||||||||||
| 7 d | 2/+/1/2/+/1 | 2/1/1/1/0/+ | 2/2/2/2/1/2 | 1/1/2/1/1/1 | ||||||||||
| 14 d | 2/+/2/1/0/0 | 2/1/1/0/0/0 | 2/2/1/2/2/1 | 2/1/1/1/0/0 | ||||||||||
| 28 d | 2/+/2/2/0/0 | 0/0/0/0/0/0 | 1/1/1/1/0/0 | 1/0/0/1/0/0 | ||||||||||
The test substance caused serious damage to eyes. All six animals exhibited severe conjunctival irritation (redness, chemosis, discharge, necrosis), corneal opacity, ulceration and iridial damage. All six animals also exhibited pannus (neovascularization of the corneal surface) one or more times between days 7 and 28. On day 7 one animal had an enlarged blood vessel on the anterior surface of the iris. Two animals had a fluid filled blister on the corneal surface on day 21 and/or 28. Three animals were noted to have hair loss around the eye. All six animals continued to exhibit severe irritation at termination of the study (day 28).
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: risk of serious damage to eyes
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