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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:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, guideline compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical State: solid
Expiry Date: 31.12.2009
Storage: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: Healthy New Zealand White Rabbits
Strain: Crl:KBL (NZW)
Source: Charles River Deutschland, D-88353 Kisslegg
Sex: female
Body weight at the beginning of the study: 4.5, 4.5, 3.9 kg
Age at the beginning of the study: approximately 13 weeks old
Number of animals: 3
The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.1 g of the test item was applied to the test site.
Duration of treatment / exposure:
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
3
Details on study design:
The test item was ground to a fine powder in a mortar with the help of a pestle.

Approximately 24 hours before the test and immediately prior to the application both eyes of the test animals were examined. A health inspection was performed to ensure the good state of health of the animals. None of the animals showed eye irritation, ocular defects, or pre-existing corneal injury.

The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.

The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response, two additional animals were treated in the same manner.

The animals were observed for 72 hours after dosing.

The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the grades in the table below. For calculation only the 24 h, 48 h and 72 hour readings were used. At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo, Lot H 801, expiry date: 01/2010).

Individual reactions of each animal were recorded at each observation time. Nature, severity and duration of all lesions observed were described. For calculation only the 24 h, 48 h, 72 hour readings were used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 Hour Reading
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 Hour Reading
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 Hour Reading
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 Hour Reading
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 Hour Reading
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
Under the conditions of the present study, single ocular instillation of the test item to rabbits at a dose of 0.1 g produced slightly irritant effects, which were fully reversible within 72 hours in animals no. 1 and 2 and within 48 hours in animal no. 3.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed. There were no significant body weight changes during observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU