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EC number: 457-900-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Jun - 25 Jul 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. No topical anaesthetics or systemic analgesics were used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- yes
- Remarks:
- no topical anaesthetics or systemic analgesics were used
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PM-5927
- Physical state: off-white powder
- Lot/batch No.: 07-02
- Expiration date of the lot/batch: 05 Feb 2008
- Storage condition of test material: at room temperature in the dark
- Other: pH (1% in water, indicative range) 5.2 - 6.0
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, the Netherlands
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 1821 - 2301 g (range)
- Housing: animals were housed individually in cages with perforated floors (56 x 44 x 37.5 cm, Scanbur, Denmark)
- Diet: pelleted diet for rabbits, K-H (SSNIFF Spezialdiäten GmbH, Soest, Germany), approximately 100 g/day. Hay (TechniLab-BMI BV, Someren, the Netherlands) was provided at least 3 times/week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - 24.1 (actual range)
- Humidity (%):43 - 80 (actual range)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, equivalent to on average 64.2 mg - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye remained unwashed after installation
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: a solution of 2% fluorescein in water (adjusted to pH 7) was instilled into both eyes of each animal to quantitatively determine the corneal epithelial damage
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour after instillation, 3/3 rabbits had slight or moderate conjunctivae (score 1 or 2) and slight chemosis (score 1) (see Table 1 under 'Any other information on results incl. tables').
At the 24- and 48-hour reading time point moderate to severe conjunctivae was noted in 3/3 animals; which persisted as slight to moderate conjunctivae until 72 hours after installation. Slight-moderate chemosis was observed in 3/3 rabbits 24 and 48 hours after installation, and in 2/3 until the 72-hour reading time point. Iritis (score 1) was observed in 3/3 rabbits until 24 hours after installation. All eye irritation effects had cleared within the 7-day reading time point. No irritation reactions were observed in the cornea. - Other effects:
- There was no mortality. No clinical signs were observed and the body weight increase was normal for this species and strain.
Any other information on results incl. tables
Table 1. Individual eye irritation scores
Rabbit #
|
Time
|
Conjunctivae/ redness |
Chemosis
|
Iris
|
Cornea
|
1
|
1 h |
1 |
1 |
1 |
0 |
24 h |
3 |
2 |
1 |
0 |
|
48 h |
3 |
1 |
0 |
0 |
|
72 h 7 d |
2 0 |
0 0 |
0 0 |
0 0 |
|
Average* |
2.67 |
1.0 |
0.33 |
0.0 |
|
2
|
1 h |
1 |
1 |
1 |
0 |
24 h |
3 |
2 |
1 |
0 |
|
48 h |
2 |
1 |
0 |
0 |
|
72 h 7 d |
2 0 |
1 0 |
0 0 |
0 0 |
|
Average* |
2.33 |
1.33 |
0.33 |
0.0 |
|
3
|
1 h |
2 |
1 |
1 |
0 |
24 h |
2 |
1 |
1 |
0 |
|
48 h |
2 |
1 |
0 |
0 |
|
72 h 7 d |
1 0 |
1 0 |
0 0 |
0 0 |
|
Average* |
1.67 |
1.0 |
0.33 |
0.0 |
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
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