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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:
20 Nov 1986 - 23 Nov 1986
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:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
shorter observation time than specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Catalyseur 30 532 – vinyltris(methylethylcetiminoxy)silane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: No data
- Weight at study initiation: 2.5 kg
- Housing: Individual in polystyrene cages
- Diet: Rabbit complete pelleted maintenance food (UAR formula "112", UAR, Villemoisson sur Orge, 91360 Epinay sur Orge), ad libitum
- Water: Softened and filtered drinking water, ad libitum
- Acclimation period: Minimum one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20.11.1986 To: 23.11.1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye is used as the control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
Single adminstration without washing.
Observation period (in vivo):
72 h (the protocol describes examinations up to 21 days but no observations are reported after 72 h)
Reading time points: 1, 24, 48, and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize scoring scheme

TOOL USED TO ASSESS SCORE: direct ophthalmoscopy / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
2.06
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1.83
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
1.78
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Other effects:
Corneal ulceration was observed in 5/6 animals up to 72 h. In 1/6 animals corneal ulceration was observed at 1 h and was reversible within 24 h. Circumcorneal injections were observed in all animals up to 72 h. In addition congestion of the iris was observed in 2/6 (48 h) and 3/6 (72 h) animals. Permanent myosis was observed in 4/6, 3/6, 3/6, and 2/6 animals at 1, 24, 48, and 72 h, respectively.

Any other information on results incl. tables

Table 1: Individual scores (1 -72 h) of the eye irritation study in rabbits.

Rabbit #

Time [h]

conjunctivae

 

iris

cornea

redness

swelling

1

1

2

3

1

2

24

2

2

1

2

48

2

2

1

2

72

2

1

1

2

average

2,0

1,7

1,0

2,0

2

1

2

3

1

2

24

2

3

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,3

1,0

2,0

3

1

1

3

1

2

24

2

2

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,0

1,0

2,0

4

1

1

3

1

2

24

1

2

1

2

48

1

1

1

0

72

1

1

1

0

average

1,0

1,3

1,0

0,7

5

1

1

3

1

2

24

2

3

1

2

48

2

3

1

2

72

2

2

1

2

average

2,0

2,7

1,0

2,0

6

1

2

3

1

2

24

2

3

1

2

48

2

2

1

2

72

2

2

1

2

average

2,0

2,3

1,0

2,0

 

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average
score

1

1,50

3,00

1,00

2,00

24

1,83

2,50

1,00

2,00

48

1,83

2,00

1,00

1,67

72

1,83

1,67

1,00

1,67

24+48+72

1,83

2,06

1,00

1,78

Applicant's summary and conclusion

Interpretation of results:
other: Irritating (according to CLP regulation)
Conclusions:
A generally reliable study, conducted according to OECD 405 and GLP but with shorter observation than required, reported that the neat test material caused significant irritation to the conjunctiva, iris and cornea of rabbits which remained at the end of the 72-h observation period.

Executive summary:

An acute eye irritation/corrosion test was performed in accordance with OECD 405 and GLP. Test item butan-2-one O,O',O''-(vinylsilanetriyl)oxime caused significant irritation to the conjunctiva, iris and cornea of rabbits which remained at the end of the 72-h observation period.