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EC number: 445-630-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-03-21 - 2003-06-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD), GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany
Test material
- Reference substance name:
- -
- EC Number:
- 445-630-0
- EC Name:
- -
- Molecular formula:
- Unspecified
- IUPAC Name:
- 1-(acetyloxy)but-3-en-2-yl acetate; 2-hydroxybut-3-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Vinylglykoldiacetat ca. 75%ig
- Testsubstance No.: 02/0526-1
- pH-value: about 4
- Physical state: liquid/colorless, clear
- Analytical purity: 74.8 area% (73.3 g/100 g)
- Other constituents:
4-Acetoxy-3-hydroxy-1-butene and 2-Acetoxy-1-hydroxy-1-butene: 17.3 area-%.(17.0 g/100 g)
3,4-Diacetoxy butane: 2.0 area-% (2.0 g/100 g)
1-Acetoxy-2-hydroxy butane: 0.8 area-% (0.8 g/100 g)
2-Acetoxy-1-hydroxy butane : 0.4 area-% (0,3 g/100 g)
4-Acetoxy crotonaldehyd: 1.8 area-% (1.8 g/100 g)
- Lot/batch No.: Kanister 1, 2,4, 5
- Date of production: Oct. 21, 2001
- Stability under test conditions: The stability under storage condition was confirmed by reanalysis.
- Storage condition of test material: Room temperature exclusion of oxygen (storage under nitrogen)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: about 4 - 5 months
- Identification: ear tattoo
- Weight at study initiation: 3.15 – 3.36 kg
- Housing: individually in Stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated left eye of same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 15
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye of the animal(s) was rinsed with 3 to 6 ml of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: about 24 hours after application
SCORING SYSTEM:
The evaluation of eye irritation is performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
Area of cornea involved (ar):
1 = >0 <= 1/4
2 = > 1/4 < 1/2
3 = > 1/2 < 3/4
4 = > 3/4
Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
Description of any ocular findings not covered by this scale were recorded.
EVALUATION OF RESULTS
For evaluation, the calculation of the mean values of corneal opacity, iris, conjunctival redness and chemosis for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.
The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.
TOOL USED TO ASSESS SCORE: hand-slit lamp (Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
Any other information on results incl. tables
Results:
| Readings | Animal | cornea | Iris | conjunctiva | Symptons | |||
| opacity | area | redness | swelling | discharge | ||||
| 1 h | 1 | 0 | 0 | 0 | 3 | 3 | 3 | |
| 2 | 0 | 0 | 0 | 2 | 3 | 3 | ||
| 3 | 0 | 0 | 0 | 3 | 3 | 3 | ||
| 24 h | 1 | 1 | 3 | 0 | 3 | 1 | 2 | sca, |
| 2 | 1 | 3 | 1 | 3 | 3 | 3 | sca, pc, db, sca | |
| 3 | 1 | 3 | 1 | 3 | 3 | 3 | sca, pc, db, sca | |
| 48 h | 1 | 1 | 3 | 0 | 2 | 0 | 1 | sca |
| 2 | 1 | 3 | 1 | 3 | 3 | 3 | s, pc, db, sca | |
| 3 | 1 | 3 | 1 | 3 | 2 | 3 | s, pc, db, sca | |
| 72 h | 1 | 1 | 1 | 0 | 2 | 0 | 0 | |
| 2 | 1 | 3 | 1 | 3 | 2 | 3 | s, pc, db, sca | |
| 3 | 1 | 3 | 1 | 3 | 2 | 3 | s, pc, db, sca | |
| 7 d | 1 | 0 | 0 | 0 | 0 | 0 | 0 | sd |
| 2 | 0 | 0 | 0 | 2 | 1 | 0 | scc | |
| 3 | 0 | 0 | 0 | 2 | 1 | 0 | sca | |
| 15 d | - | - | - | - | - | - | - | - |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 1.0 | 0.0 | 2.3 | 0.3 | |||
| 2 | 1.0 | 1.0 | 3.0 | 2.7 | ||||
| 3 | 1.0 | 1.0 | 3.0 | 2.3 | ||||
| mean | 1.0 | 0.7 | 2.8 | 1.8 | ||||
s = Suppuration
pc = Pupil contracted
db = Discharge of blood
sca = Scleral vessels injected, circumscribed area
scc = Scleral vessels injected, circular
sd= study discontinued because the animal was free of findings
Applicant's summary and conclusion
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