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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: LV 86

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation: adult
- Weight: 1.5-2 kg
- Housing: individually in metal cages
- Diet: ad libitum access to standard rabbit food - NAFAG, Gossau SG
- Water: ad libitum access to water
- Acclimation period: a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Negative control: Untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
one instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6: 3 male, 3 female
Details on study design:
Application: The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

SCORING SYSTEM: The eye irritation was appraised on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit on Cornea (Opacity, Area involved), Iris and Conjunctiva (Redness, Chemosis, Discharge).

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
4
Remarks on result:
other: unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2-7 days
Score:
0
Max. score:
4
Remarks on result:
other: unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Max. score:
4
Remarks on result:
other: rinsed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Max. score:
2
Remarks on result:
other: unrinsed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Max. score:
2
Remarks on result:
other: rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Max. score:
4
Remarks on result:
other: unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Max. score:
4
Remarks on result:
other: rinsed eyes
Irritation parameter:
other: primary irritation index
Basis:
mean
Time point:
other: 1-7 days
Score:
0.33
Remarks on result:
other: unrinsed eyes
Irritation parameter:
other: primary irritation index
Basis:
mean
Time point:
other: 1-7 days
Score:
0
Remarks on result:
other: rinsed eyes
Irritant / corrosive response data:
The test substance was found to cause a minimal irritation when applied to the rabbit eye mucosa.

Any other information on results incl. tables

Time after exposure

days

Mean reaction score of 3 rabbits per inspection time

Unrinsed eyes

Rinsed eyes

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

1.67

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

4

0

0

0

0

0

0

7

0

0

0

0

0

0

Subtotal

1.67

0

0

0

0

0

Total

1.67

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met