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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:
January 14, 1964 - February 19, 1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
No details on animal housing and environmental conditions
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
Amount applied: 0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
STUDY DESIGN
The test material was applied undiluted in 3 animals.

TREATMENT
In accordance with OECD 405 (1981). The test substance is placed in the conjunctival sac of right eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes of each animal were examined approximately 24, 48, 72, 96 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal: #1, #2 and #3 (mean)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3 (mean)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1 and #2
Remarks:
(mean)
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean)
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
The substance caused a mild conjunctival (redness) and a slight/mild chemosis in all three animals. The effects were fully reversible within 7 days.

Any other information on results incl. tables

Ocular Irritant response data (for the undiluted test substance)

 

                                           Time after administration

 

       1 day

       2 days

       3 days

       4 days

       7 days

 Animal:  1  3  1  2  3  1  2  3
 Cornea score (opacity)  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Iris score  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Conjunctivae score (redness)  2  3  2  2  2  1  2  1  1  1  0  0  0  0
 Chemosis score  2  2  2  2  1  1  1  1  0  1  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
other: Eye irritant Cat 2
Remarks:
According to Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
In an eye irritation study with three rabbits, performed equivalent to OECD 405 guideline, irritation was observed. Based on the results of this study, the substance is considered an eye irritant.
Executive summary:

The substance was tested in an eye irritation test in three rabbits equivalent to OECD 405 guideline. The substance did not cause effects on cornea or iris. In 2/3 animals conjunctivae score 2 during the first two days meeting the criteria for considering the substance a severe eye irritant. Effects on chemosis are mild. The effects were fully reversible within 7 days. The results show that the substance is considered to be severe irritating to eyes.