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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
of 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
Certified by BAM according to DIN EN 45001.

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Number: 3 animals,
- Average bodyweight: 3.2 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
Prior to dosing the animals were starved for 16 hours.
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS

Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.

Test system

Vehicle:
other: undiluted (no vehicle) after warming the test material to 37°C
Controls:
not required
Amount / concentration applied:
After warming undiluted test material (no vehicle) to 37°C, 0.1 ml of it was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control.
Duration of treatment / exposure:
There was no mentioning in the report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 7 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
Observation period (in vivo):
7 days post instillation
Number of animals or in vitro replicates:
3 adult rabbits
Details on study design:
Eyes were evaluated for occular lesions using ultraviolet light. The numerical scoring system listed in Table 1 in the field below was adopted. Time points of evaluation were: Pretest (prior to treatment), 1, 2, 4, 8, 24, 48, 72 and 96 hours after administration and daily thereafter until 7 days after administration. Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification or non-classification.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal irritation or opacity was not evident during the study
Irritation parameter:
iris score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Iridal changes were not evident during the study
Irritation parameter:
other: lacrimation score
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal irritation or opacity was not evident during the study
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal irritation or opacity was not evident during the study
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Corneal irritation or opacity was not evident during the study
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Iridal changes were not evident during the study
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Iridal changes were not evident during the study
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Iridal changes were not evident during the study
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Chemosis was not evident during the study
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Chemosis was not evident during the study
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Chemosis was not evident during the study
Irritant / corrosive response data:
Corneal and iridic lesions and chemosis were not evident throughout the study. Conjunctival redness grade 1 and lacrimation usually grade 1, in one incidence grade 2, were seen in all treated eyes at 1, 2, 4 and/or 8 hours post instillation of the test substance. Conjunctival redness had completely disappeared in one of the animals by 8 hours post instillation and in the other two by 24 hours post instillation and lacrimation had completely disappeared in two of the animals by 8 hours post instillation and in the other one by 24 hours post instillation. Daily examination of the eyes from 24 hours until 7 days post instillation did not reveal any findings.
Other effects:
Daily determination of bodyweight did not reveal any test related changes. Bodyweight gain was normal.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
not classified according to Regulation (EC) 1272/2008
Conclusions:
The outcome of the present study does not necessitate any classification or labelling regarding eye irritation according to REGULATION (EC) 1272/2008. The minor findings noted were fully reversible and within the category “not irritating to eyes”.