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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP study and not according to a recent international test guideline but according to a US regulation. The results are well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
GLP compliance:
no
Remarks:
Study from 1974

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetaldehyde oxime
EC Number:
203-479-6
EC Name:
Acetaldehyde oxime
Cas Number:
107-29-9
Molecular formula:
C2H5NO
IUPAC Name:
acetaldehyde oxime
Details on test material:
- Test material: 50% AAO

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Young adult albino rabbits, selected from healthy, acclimated animals

Test system

Controls:
no
Observation period (in vivo):
72 h - Ocular reactions were observed and recorded at 24, 48 and 72 h after instillation of the test material.
Number of animals or in vitro replicates:
6
Details on study design:
No washout

SCORING SYSTEM: very similar to DRAIZE

Results and discussion

In vivo

Irritant / corrosive response data:
The test material produced corneal effects in 5 of the animals, iridial effects in 3 of the animals and conjunctival effects in all 6. None of these effects cleared by the 72 h observation period.

Any other information on results incl. tables

Rabbit

 

Tissue

24 h

48 h

72 h

1

A

Cornea opacity

1

1

1

 

B

Cornea Area

4

4

4

 

 

(1) Cornea Total = (AxB) x 5

20

20

20

 

C

Iris

1

1

 

 

(2) Iris Total = (C) x 5

10

5

5

 

D

Conjunctiva Redness

1

2

2

 

E

Conjunctiva Chemosis

3

3

2

 

F

Conjunctiva discharge

3

3

3

 

 

(3) Conjunctiva Total = (D+E+F) x 2

14

16

14

 

 

Totals Added = (1+2+3)

44

41

39

 

 

 

 

 

 

2

A

Cornea opacity

1

1

1

 

B

Cornea Area

4

4

4

 

 

(1) Cornea Total = (AxB) x 5

20

20

20

 

C

Iris

0

0

0

 

 

(2) Iris Total = (C) x 5

0

0

0

 

D

Conjunctiva Redness

1

2

2

 

E

Conjunctiva Chemosis

2

2

1

 

F

Conjunctiva discharge

3

3

3

 

 

(3) Conjunctiva Total = (D+E+F) x 2

12

14

12

 

 

Totals Added = (1+2+3)

32

34

32

 

 

 

 

 

 

3

A

Cornea opacity

1

1

1

 

B

Cornea Area

4

2

2

 

 

(1) Cornea Total = (AxB) x 5

20

10

10

 

C

Iris

1

0

0

 

 

(2) Iris Total = (C) x 5

5

0

0

 

D

Conjunctiva Redness

2

2

2

 

E

Conjunctiva Chemosis

3

2

2

 

F

Conjunctiva discharge

3

2

2

 

 

(3) Conjunctiva Total = (D+E+F) x 2

16

12

12

 

 

Totals Added = (1+2+3)

41

22

22

 

 

 

 

 

 

4

A

Cornea opacity

1

1

1

 

B

Cornea Area

4

4

4

 

 

(1) Cornea Total = (AxB) x 5

20

20

20

 

C

Iris

0

0

0

 

 

(2) Iris Total = (C) x 5

0

0

0

 

D

Conjunctiva Redness

1

3

2

 

E

Conjunctiva Chemosis

3

4

3

 

F

Conjunctiva discharge

3

3

3

 

 

(3) Conjunctiva Total = (D+E+F) x 2

14

20

16

 

 

Totals Added = (1+2+3)

34

40

36

 

 

 

 

 

 

5

A

Cornea opacity

2

2

1

 

B

Cornea Area

4

4

4

 

 

(1) Cornea Total = (AxB) x 5

40

40

20

 

C

Iris

2

1

0

 

 

(2) Iris Total = (C) x 5

10

5

0

 

D

Conjunctiva Redness

2

2

1

 

E

Conjunctiva Chemosis

2

2

1

 

F

Conjunctiva discharge

3

2

2

 

 

(3) Conjunctiva Total = (D+E+F) x 2

14

12

8

 

 

Totals Added = (1+2+3)

64

57

28

 

 

 

 

 

 

6

A

Cornea opacity

0

0

0

 

B

Cornea Area

0

0

0

 

 

(1) Cornea Total = (AxB) x 5

0

0

0

 

C

Iris

0

0

0

 

 

(2) Iris Total = (C) x 5

0

0

0

 

D

Conjunctiva Redness

2

2

2

 

E

Conjunctiva Chemosis

2

2

1

 

F

Conjunctiva discharge

3

2

1

 

 

(3) Conjunctiva Total = (D+E+F) x 2

14

12

8

 

 

Totals Added = (1+2+3)

14

12

8

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
On the basis of the data the test material is a severe irritant to the eye.
Executive summary:

The test material produced corneal effects in 5 of the animals, iridial effects in 3 of the animals and conjunctival effects in all 6. None of these effects cleared by the 72 h observation period.

Rabbits were not observed after 21 days, so it cannot be concluded if the observed effects are reversible or not.