Registration Dossier
Registration Dossier
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EC number: 425-150-8 | CAS number: 94723-86-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 425-150-8
- EC Name:
- -
- Cas Number:
- 94723-86-1
- Molecular formula:
- C15 H22 O3 S
- IUPAC Name:
- 2-butanoyl-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
- Details on test material:
- - Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.4 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: guaranteed by the sponsor and verified by reanalysis
- Storage condition of test material: refrigerator
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: WHITE NEW ZEALAND (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; 3.99-4.0 kg
- Fasting period before study: none
- Housing: single housing
- Diet: KLIBA-Labordiaet 341, Klingenthalmuehle AG Kaiseraugst, Switzerland, about 130 g per day
- Water: tap water about 250 ml per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.
Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 20 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days (since all ocular lesions induced by the treatment returned to normal on day 8 the study was terminated. Therefore, the reduced observation period does not represent a deviation from the protocol recommended by the guidance documents.)
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Tap water
- Time after start of exposure: 24 hours
SCORING SYSTEM: The OECD Draize scoring system was used (OECD guideline no. 405 (adopted February 24, 1987))
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2; #3
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #3
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Other effects:
- In animal #2, loss of corneal tissue was observed 24 h post application.
Any other information on results incl. tables
| Readings | Animal | Cornea | Iris | Conjunctiva | Additional findings | |
| red | ch | |||||
| 24 h | 1 | 1 | 1 | 3 | 2 | LC |
| 2 | 0 | 0 | 2 | 0 | ||
| 3 | 0 | 0 | 2 | 1 | ||
| 48 h | 1 | 0 | 0 | 2 | 1 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | 1 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| 8 d | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
Symbols:
LC: Loss of corneal tissue
.
Applicant's summary and conclusion
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