(E)-3-formylbut-2-enyl acetate

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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.