Registration Dossier
Registration Dossier
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EC number: 202-509-5 | CAS number: 96-48-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- Study in animals performed before Annex VII and VIII amendments.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Apr 2005 - 16 May 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study (OECD 405)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Eyes were rinsed after treatment
- GLP compliance:
- yes
Test material
- Reference substance name:
- γ-butyrolactone
- EC Number:
- 202-509-5
- EC Name:
- γ-butyrolactone
- Cas Number:
- 96-48-0
- Molecular formula:
- C4H6O2
- IUPAC Name:
- dihydrofuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): γ-Butyrolacton
- Analytical purity: 99.79%
- Purity test date: 21 Feb 2005
- Lot/batch No.: Behaelter B62
- Other: pH: ca. 5
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lago S.A., France
- Age at study initiation: ca. 3 month
- Weight at study initiation: 2.41 kg
- Housing: single
- Diet: KLIBA Labordiaet (Kaninchen & Meerschweinchenhaltung), Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.1 ml (undiluted)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 28 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye 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: 24 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 28 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Findings animal #1:
| Time | Opacity | Iritis | Conjunctival Erythema | Conjunctival Chemosis | |
| 1 h | - | - | 2 | 4 | |
| 24 h | 1 | 1 | 2 | 3 | |
| 48 h | 1 | 1 | 2 | 2 | |
| 72 h | 2 | 1 | 2 | 2 | |
| 8 d | 2 | 2 | 2 | 2 | |
| 14 d | 1 | 0 | 0 | 0 | |
| 21 d | 1 | 0 | 0 | 0 | |
| 28 d | 1 | 0 | 0 | 0 | |
| Mean: 24h - 48h - 72h | 1.3 | 1 | 2 | 2.3 | |
Slight or moderate corneal opacity, moderate to severe iritis, moderate conjunctival redness, moderate to severe conjunctival chemosis and slight to severe discharge were observed in the animal during the course of the study. Additional findings like discharge of blood, contracted pupil, white discolored parts of the conjunctiva and nictitating membrane, marginal vascularization of the cornea as well as vascularization into the central part of the cornea, both in a circumscribed area, and injected scleral vessels in a circumscribed area or circular were noted in the animal during the observation period. The ocular reactions were not reversible in the animal within 28 days after application.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-corrosive but causes irreversible eye effects according to criteria in Regulation (EC) No 1272/2008
- Remarks:
- Criteria used for interpretation of results: EU
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