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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 November 1996 to 30 April 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
At the start of the study the males rabbits weighed 3.0 kg and were 19 weeks old. Free access to mains drinking water and food was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 20+-2 C and 45 to 75% respectively. The rate of air exchange was 10-12 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of each animal was untreated
Amount / concentration applied:
100 mg fine ground test material
Duration of treatment / exposure:
100 mg test material to the non-irrigated eye of three rabbits was performed by placing test material in the conjunctival sac of the right eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loose of material and then released. The left eye was left untreated to serve as the control.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were perfomed on day 5 to 9 to assess the reversibilityof the ocular effects.
Number of animals or in vitro replicates:
3 males rabbits
Details on study design:
Before treatment both eyes were checked for sign of ocular irritation or defect with the aid of a direct light source. Only animals free of ocular damage were used in the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: day 8
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: day 8
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 9days
Remarks on result:
other: Max. duration: day 7
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24,48 and 72 hr
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: day 5
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24,48 and 72 hr
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: max duration day 6
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24,48 and 72 hr
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: max duration day 5
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration:day 6
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: day 7
Irritation parameter:
cornea opacity score
Remarks:
degree of opacity
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: day 6
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: 72 hr
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: 72 hr
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: Max. duration: 72 hr
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 9 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as an irritant.