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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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-2-oxazoline
EC Number:
233-912-4
EC Name:
2-ethyl-2-oxazoline
Cas Number:
10431-98-8
Molecular formula:
C5H9NO
IUPAC Name:
2-ethyl-2-oxazoline
Test material form:
liquid
Specific details on test material used for the study:
- Name of test item as cited in study report: 2-ethyloxazolin
- Substance number: 81/150

Test animals / tissue source

Species:
rabbit
Strain:
other: Weisser wiener
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Firma gaukler 6050 offenbach/Main
- mean weights: 2.64 kg for males, 2.73 kg for females
- housing: housed singly in cages; stainless steel with wire inlaid floor (dimensions: 40 cm x 51 cm)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 26 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
- at 1, 24, 48, 72 hours and 8 and 14 days post treatment
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
- instilled into conjuctiva of right eye
- effects scored using Draize (1959) rating system
- test item is not washed out

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
24 h
Score:
37
Max. score:
37
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
48 h
Score:
37
Max. score:
39
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
72 h
Score:
36
Max. score:
39
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
other: 8 d
Score:
39.3
Max. score:
57
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks:
fully reversed in 2/6 animals
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 animals
Time point:
14 d
Score:
37
Max. score:
73
Reversibility:
not reversible
Irritant / corrosive response data:
Irritation to the cornea, the iris, and conjunctiva were scored using the Draize system.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The eyes of six rabbits (3 males and 3 females) were instilled with 0.1 mL of ETOX and then observed at 1, 24, 48, 72 hours then again at 8 and 14 days following application. Only one eye was treated and the other eye was left untreated as a negative control. Average overall irritation scores at 24, 48, 72 hrs and at 8 and 14 days were 37, 37, 36, 39, and 37 respectively. The results were not fully reversed by the end of the 14 day study period.