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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:
1977-08-23 (day of application)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register Vol. 38, No. 137, § 1500.42 (1973)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
(E)-3-formylbut-2-enyl acetate
EC Number:
247-825-4
EC Name:
(E)-3-formylbut-2-enyl acetate
Cas Number:
26586-02-7
Molecular formula:
C7H10O3
IUPAC Name:
(2E)-3-methyl-4-oxobut-2-en-1-yl acetate
Details on test material:
- Name of test material (as cited in study report): beta-formylcrotylacetate (2-methyl-4-acetoxy-butenal)
- Physical state: liquid
- Analytical purity: no data
No further data.

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
male and female albino rabbits
- Weight at study initiation: ca. 3 - 4 kg
- Housing: individually in stainless steel cages
- Diet (ad libitum): pelleted standard diet for rabbits
- Acclimation period: at least 3 days
no further data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23°C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the unchanged test substance
Duration of treatment / exposure:
4 hour
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke warm tap water (20 ml)
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The eyes were scored at 1 hour, 24, hours, 48 hours, 72 hours, and 7 days after beginning of instillation. Findings were assessed according to the Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 - 72 h
Score:
1.78
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 - 72 h
Score:
0.56
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 - 72 h
Score:
1.72
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 - 72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
of n=6
Time point:
other: 24 - 72 h
Score:
49
Max. score:
76
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: possible maximum: 110

Any other information on results incl. tables

Table: Draize scores (24 – 72 h)
 
Score
24 h
48 h
72 h
Animal no.
Animal no.
Animal no.
1
2
3
4
5
6
1
2
3
4
5
6
1
2
3
4
5
6
Cornea (1)
Opacity (A)
2
2
2
2
2
1
2
3
2
1
2
1
2
2
2
1
2
1
Area (B)
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
AxBx5 (max. 80)
40
40
40
40
40
20
40
60
40
20
40
20
40
40
40
20
40
20
Iris (2)
Score
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0
0
0
Score x 5 (max. 10)
0
0
0
0
0
0
0
10
0
0
0
0
0
0
0
0
0
0
Conjunctivae (3)
Redness (A)
2
1
1
2
1
1
2
2
2
2
2
2
2
2
2
2
2
1
Chemosis (B)
4
4
4
3
3
3
4
4
4
2
3
3
4
4
4
2
3
2
Lacrimation (C)
2
2
2
2
2
2
2
2
2
2
1
2
2
2
2
1
1
1
(A+B+C)x2 (max. 20)
16
14
14
14
12
12
16
16
16
12
12
14
16
16
16
10
12
8
Total score (1)+(2)+(3) (max. 110)
56
54
54
54
52
32
56
76
56
32
52
34
56
56
56
30
52
28
 
Other Observations:
During and after instillation: defensive movements and eyelid closure
24 h through 7 days post instillation: partial or complete adhesions of the conjunctivae due to suppuration
7 days post instillation: no findings in 2/6 rabbits; mean irritation index was 48.5 for the remaining 4 animals (no further details given)

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
The authors considered the test substance to be moderately irritating, based on the total irritation scores (in the range between 30 and 76; possible max = 110). Based on the corneal opacity (persisting at the end of the observation period without any indication of reversibility), the test substance has to be classified as corrosive Cat. 1.

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