Registration Dossier

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:
1989-11-27 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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12th, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Delta-Valerolacton

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