Registration Dossier
Registration Dossier
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EC number: 208-807-1 | CAS number: 542-28-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-11-27 to 1989-12-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study similar to guideline but without GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12th, 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- δ-valerolactone
- EC Number:
- 208-807-1
- EC Name:
- δ-valerolactone
- Cas Number:
- 542-28-9
- Molecular formula:
- C5H8O2
- IUPAC Name:
- tetrahydro-2H-pyran-2-one
- Details on test material:
- Delta-Valerolacton
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO/MED.VERSUCHSTIERZUCHTEN GMBH, 7964 Kisslegg/ Algäu Germany
- Weight at study initiation: 3.31 kg (male), 3.06 kg (female)
- Housing: CAGE MADE OF STAINLESS STEEL WITH WIRE MESH WALK FLOORS, FLOOR AREA: 40 CM X 51 CM
- Diet: ABOUT 130 G PER ANIMAL PER DAY (KLIBA 341, 4 MM; FIRMA KLINGENTALMUEHLE AG CH-4303 KAISERAUGST, SWITZERLAND)
- Water: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 DEGREES CELSIUS
- Humidity: 30 - 70 %
- Photoperiod: 12 H/12 H (6.00 - 18.00 HOURS/ 18.00 - 6.00 HOURS)
- Acclimatisation: AT LEAST 8 DAYS
IN-LIFE DATES: no data given
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (unchanged) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 rabbits (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: According to OECD Guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: findings could not be read - Ulcus corneae
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: findings could not be read - Ulcus corneae
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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