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Diss Factsheets

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:
study report 12 Nov. 1976 (no additional details)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. rederel Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Remarks:
slight modification (no additional details)
GLP compliance:
no
Remarks:
prior to GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane
EC Number:
701-135-4
Cas Number:
30499-70-8
Molecular formula:
C15H26O6;C15H22O5
IUPAC Name:
Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy New Zealand White rabbits (Porton strain) aged 13 - 17 weeks with average body weights of 3.04 kgs. (male) and 2.46 kgs. (female), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 male and 3 female) were acclimatised in the test area for one week prior to the start of the trial.
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (+/-1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08:00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits. The eyes of other three rabbits remained unwashed.
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
6
Details on study design:
The eyes of the experimental animals were examined and found normal prior to the test.
0.1ml of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 ml. of warm water.
The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in rood Drugs and Cosmetics" page 51, published by the Association of rood and Drug Officials of the U.S.A. Corneal damage was assessed after staining with fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eye washed
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eye washed
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eye washed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: eye washed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
15
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
15
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
30
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
5
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
30
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
5
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
15
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
30
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
5
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
40
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
10
Max. score:
80
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
5
Max. score:
20
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
61
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
32
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
26
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
63
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
47
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
13
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
61
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
49
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
7
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
61
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
30
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
4
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
59
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
47
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
7
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
61
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
14
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
2
Max. score:
110
Reversibility:
not reversible
Irritant / corrosive response data:
The 3 rabbits with unwashed eyes were killed after 6 days because of the severity of the reactions.

Conjunctiva. A slight to moderate reaction was seen in all treated eyes one hour after the application of the compound. This was still present at 24 hours. Small areas of necrosis were seen in 2/3 unwashed eyes from 24 hours onwards and in the third unwashed eye at 6 days. Because
of the severity of the reactions these rabbits were killed at this time. Washed eyes had returned to normal by 6 days {one eye) and 10 days (2 eyes).

Cornea. Slight opacity with damage to the surface epithelium was seen in all treated eyes at one hour. By 24 hours, the unwashed eyes were showing small areas of ulceration, whereas the reactions in washed eyes were similar to those at one hour. Slight pannus was present in the 3 unwashed eyes at 6 days. The washed eyes had returned to normal by 48 hours (one eye) and 6 days (2 eyes).

Iris: Increased folding was seen in 3/3 unwashed and 2/3 washed eyes at 24 hours. The washed eyes had returned to normal by 48 hours (one eye) and 72 hours (one eye). The unwashed eyes were still showing a reaction at 6 days.

Washed eyes showed a much less severe reaction than unwashed eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test material is a corrosive eye irritant in the albino rabbit on clinical assessment.
Executive summary:

The irritative effects of the test material was assessed in six New Zealand White rabbits exposed to 0.1ml of the test compound instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. In three animals, after 30 seconds, the compound was flushed out of the eyes with approximately 200 ml. of warm water. The rabbits were examined 1, 24, 48 and 72 hours and day 6 and 10 after application of the test compound. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in rood Drugs and Cosmetics" page 51, published by the Association of rood and Drug Officials of the U.S.A. Corneal damage was assessed after staining with fluorescein.

Small areas of necrosis were seen in 2/3 unwashed eyes from 24 hours onwards and in the third unwashed eye at 6 days. The washed eyes had returned to normal by 48 hours (one eye) and 6 days (2 eyes).

The test material is a corrosive eye irritant in the albino rabbit based on clinical assessment.