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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989 - 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study according to OECD TG 405 (adopted May 12th, 1981) without GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
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

Constituent 1
Chemical structure
Reference substance name:
2-methylvaleraldehyde
EC Number:
204-605-2
EC Name:
2-methylvaleraldehyde
Cas Number:
123-15-9
Molecular formula:
C6H12O
IUPAC Name:
2-methylpentanal
Details on test material:
- Name of test material: 2-METHYLPENTANAL

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FRG
- Age at study initiation: no data
- Weight at study initiation: 3.29 kg (male rabbit), 3.95 kg (females)
- Housing: CAGE MADE OF STAINLESS STEEL WITH WIRE MESH WALK FLOORS, FLOOR AREA: 40 CM X 51 CM, 1 Animal/cage
- Bedding: NO BEDDING IN THE CAGES; SAWDUST IN THE WASTE TRAYS
- Diet: KLIBA 341, 4 MM; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAV)
- Water: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: AT LEAST 8 DAYS BEFORE THE BEGINNING OF THE STUDY; SAME HOUSING CONDITIONS AS DURING THE STUDY

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 DEGREES CELSIUS
- Humidity: 30 - 70 %
- Air changes (per hr): FULLY AIR-CONDITIONED ROOMS
- Photoperiod (hrs dark / hrs light): 12 H/12 H

IN-LIFE DATES: From: 1989-12-11 To: 1989-12-27

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated (left) eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ML (UNCHANGED)
- Application site: SINGLE APPLICATION TO THE CONJUNCTIVAL SAC OF THE RIGHT EYELID
Duration of treatment / exposure:
continuous - THE SUBSTANCE WAS NOT WASHED OUT
Observation period (in vivo):
16 days (readings performed 1 hr, 24, 48, 72 hrs and 8, 16 d after instillation)
Number of animals or in vitro replicates:
1 Males, 2 Females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
0.3
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 16 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 16 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
2.1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
1.8
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU