Registration Dossier
Registration Dossier
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EC number: 234-679-1 | CAS number: 12023-27-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-02-19 until 1990-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diiron titanium pentaoxide
- EC Number:
- 234-679-1
- EC Name:
- Diiron titanium pentaoxide
- Cas Number:
- 12023-27-7
- Molecular formula:
- Fe2O5Ti
- IUPAC Name:
- titanium(4+) diiron(3+) pentaoxidandiide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 2 male and 1 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.88 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye remained as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Rinsing of the eyes were not performed
- Observation period (in vivo):
- 1 hour after treatment and then daily up to 8 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: The rabbits were investigated for eye irritation and for changes in behavior and general condition 1hour after treatment and then daily for a period of 8 days.
SCORING SYSTEM: Local changes of the eye were evaluated according to Draize.
TOOL USED TO ASSESS SCORE: fluorescein
24 hours before treatment ophthalmological examinations were performed after instillation of 0.15% fluorescein solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- - Lesions and clinical observations:
All animals survived the observation period. No signs of systemic toxicity were seen. The body weight development of the treated rabbits was inconspicuous.
- Other observations: Only brown discoloration of the hairs around the eyes was observed on day 1 and 2 of the study due to the coloration of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No eye irritating potential could be detected.
- Executive summary:
The test material was tested according OECD TG 405 for acute eye irritation in three New Zealand White rabbits (2 males and 1 female). Aliquots of 0.1 g were applied into the conjunctival sac of the left eye of each rabbit. The right eye remained untreated and served as a control. The rabbits were examined for eye irritation daily up to day 8 of the study. Eye reactions were evaluated and graded according to Draize scale. After instillation of the test material, no irritancy was observed in all animals. Based on the results of this study, undiluted test substance is evaluated as non-irritating to the eyes.
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