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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)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino rabbit; Crt: KBL (NZW) BR
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, KiBlegg
- Age at study initiation: 14 weeks
- Weight at study initiation: 3.05 kg
- Housing: The animals were housed in air conditioned rooms at the Institute of Toxicology.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 59-75%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: June 5, 1997 To: July 17, 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eye was examined after 1 hour of treatment, 24, 48, 72 hours and then daily up through day 22 of the experimental part. Body weight was recorded on day 1 and also on days 5, 8, 11, 15, and 22.
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
3.75
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Remarks on result:
other: The iris was not visible up to day 5
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
1.25 - 2.25
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is considered to be an eye irritant for regulatory purposes. The weight of the rabbit increased from 3.05 kg to 3.51 over the course of the study period.
Executive summary:

This study examined the potential of the test substance to cause irritation to eyes. 0.1 g of test substance was placed in one eye of one female rabbit. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours, as well as daily up until day 22 after application. The mean score for the cornea was 3.75, while the mean score for the iris was not determined as it was not able to be seen until day 5 of the study. The mean conjunctivae scores were 1.25 and 2.25 for A and B, respecitively. The test substance is classified as an eye irritant under EU GHS guidelines.