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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no details on content in the report

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
- Humidity: 50 %

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
1 second
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (score 0).
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.