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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA, §163.81-4"Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, number of animals used was 6 instead of 3.
GLP compliance:
no
Remarks:
Quality Assurance Unit statement was given.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Physical appearance: white powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Weight at study initiation: 2-3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Photoperiod: 10 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
Test material: 0.1 g
Duration of treatment / exposure:
3 animals: single treatment, rinsing after 30 seconds
3 animals: single treatment, no rinsing
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals (with rinsing)
3 animals (no rinsing)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 10 ml lukewarm water (in 3/6 animals)
- Time after start of exposure: 30 seconds

Scoring system: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Study design
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were heldopen for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: without rinsing
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: without rinsing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: without rinsing
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: without rinsing
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: without rinsing
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: without rinsing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: without rinsing
Irritant / corrosive response data:
In the 3 animals where the test substance was rinsed after 30 seconds, no findings were observed within the whole observation period. Without rinsing 1/3 animals showed a conjunctivae score of 1 after 24 h, which was reversible within 48 h. No other effects were observed.

Any other information on results incl. tables

Table 1: Eye irritation scores of treated animals without rinsing at 24 h, 48 h, and 72 h.

 

 

24 h

48 h

72 h

 

 

Rabbit No.

111

112

113

111

112

113

111

112

113

 

Cornea

Opacity

0

0

0

0

0

0

0

0

0

 

 

Area

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

Iris

Iris

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

Conjunctivae

Redness

0

0

1

0

0

0

0

0

0

 

 

Chemosis

0

0

0

0

0

0

0

0

0

 

 

Discharge

0

0

2

0

0

1

0

0

0

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment the test material was found to to be not irritating to the rabbit eye mucosa.
Executive summary:

The substance was tested on 6 New Zealand White rabbits (3 males/3 females) according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) §163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The eyes were scored daily from 24 h until day 4 and again at 7 d after begin of treatment. No findings regarding cornea, iris or chemosis were observed within the whole study period in animals without rinsing of test substance. Slight redness was observed in 1/3 animals (score: 0.3; 24 -72 h), which was fully reversible within 48 h. Thus, the test substance has no potential as an eye irritant.