Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-807-1 | CAS number: 542-28-9
Toxicological information
Eye irritation
Currently viewing:
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
