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EC number: 234-933-1 | CAS number: 12042-91-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2001 - 30 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test was conducted according to OECD Test Guideline No. 405, 1987, under GLP Standards, and QA.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 92/69/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Locron P
- Physical state: white powder
- Analytical purity: confidential
- Lot/batch No.: confidential
- Stability under test conditions: no data
- Storage condition of test material: at approx. 20 °C in a fume cupboard
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: no data
- Weight at study initiation: 2.9 - 3.2 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- At 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed out thoroughly with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 hours and at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed
SCORING SYSTEM: subjective numerical according to OECD Guideline 405 (corneal (opacity and area), iridic and conjunctival irritation (redness/chemosis/discharge)).
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serious-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2 Individual scores
|
1h |
24h |
48h |
72h |
Mean 24/48/72h |
Corneal opacity |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Iris |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Redness |
2 / 2 / 2 |
2 / 2 / 2 |
1 / 1 / 1 |
0 / 0 / 0 |
1 / 1 / 1 |
Chemosis |
3 / 3 / 3 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Discharge |
2 / 2 / 2 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
An eye irritation study was performed according to OECD Guideline 405 and in compliance with GLP. One eye of three rabbits each was exposed to 0.1g of the test substance for 24 hours. Observation occurred at 1, 24, 48 and 72 hours. One hour up to 48 hours after administration the conjunctivae of all animals showed definitely injected blood vessels up to diffuse crimson color, so that individual vessels were not easily discernible. Swelling with lids about half closed was observed in all animals one hour after administration. In addition, serous-colorless eye discharge was noted. 72 hours after administration all signs of irritation had completely disappeared.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 1.0 / 1.0 / 1.0 for conjunctivae score and 0.0 / 0.0 / 0.0 for chemosis score.
Under the test conditions, the test material Locron P is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
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