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:
July 5th, 1988 - July 9th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
yes
Remarks:
purity of test substance not given
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Caprylic/Capric Triglyceride
- Physical state: pale straw-coloured clear liquid
- Date of arrival: 23 March 1988
- Storage conditions: room temperature
- Analytical purity: no data
no further details given

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.76 - 3.34 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 65 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left untreated eye of the animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged test substance
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 tested animals and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 tested animals and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #4, #5, #6 and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #2, #3, #4, #5, #6 and mean of 3 readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information to the rabbit eye in vivo. Criteria used for interpretation of results: EU