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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:
from 2000-02-28 to 2000-03-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
, 1997
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2 - 2.6 kg bw
- Housing: The rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
- Acclimation period: At least one week.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 times/hour
- Photoperiod: 12 hours light and 12 hours darkness (light was on from 6 a.m. to 6 p.m.)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL


Duration of treatment / exposure:
Single treatment, eyelids were held together for about 1 second.
Observation period (in vivo):
7 days, assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
4
Details on study design:
0.1 mL of the test article was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second. The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 mL 0.9 % sodium chloride solution the eye were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours as well as 7 days after the treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Reading after instillation of Fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Reading after instillation of Fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Reading after instillation of Fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: mean 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Reading after instillation of Fluorescein

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A test was conducted to assess the eye irritating potential of the test item to rabbits' eyes. Four rabbits were used. As a result, the substance was considered to be non irritating to eyes.
Executive summary:

A test was conducted to assess the eye irritating potential ot the test item to rabbits' eyes. Four SPF albino rabbit were used. The study was performed in accordance to GLP and OECD Guideline 405. After a single application of 0.1 mL of the test item, the animals were observed for a period of 7 days and eye reactions were recorded at 1, 24, 48 and 72 hours. The mean scores for cornea opacity calculated for the time points 24, 48 and 72 hours were 0, 0, 0.7 and 0.3 for animal 1, 2, 3 and 4, respectively. Iris mean scores were 0 for each of the four animals. The conjunctiva scores were calculated to be 0.7, 0.7, 1.7, 1.7 and chemosis scores were 0, 0.3, 0.7, 0.3. All findings were reversible within the observation period of 7 days. On the basis of four results, the substance is considered to be non irritating to the rabbits' eyes.