Methyl benzoylformate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, §1500.41, S. 27019 vom 27.09.73

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

72h observation period only (acceptable, as very mild findings only)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl benzoylformate

EC Number:

239-263-3

EC Name:

Methyl benzoylformate

Cas Number:

15206-55-0

Molecular formula:

C9H8O3

IUPAC Name:

methyl oxo(phenyl)acetate

Details on test material:

- Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean: 3.0 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hours not washed out

Observation period (in vivo):

24, 48, 72 hours

Number of animals or in vitro replicates:

3 female

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

Animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

Animal 2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

Animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

Animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

mean

Remarks:

Animal 2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

Animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal 1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal 2

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal 3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal 1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal 2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

Animal 3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Results:

				Conjunctivae
animal	time after application	cornea	iris	Redness	Chemosis
1	24 hours	0	0	1	0
	48 hours	0	0	1	0
	72 hours	0	0	1	0
2	24 hours	0	0	1	0
	48 hours	0	0	1	0
	72 hours	0	0	0	0
3	24 hours	0	0	1	0
	48 hours	0	0	1	0
	72 hours	0	0	1	0
1	mean 24-72 h	0.0	0.0	1.0	0.0
2		0.0	0.0	0.7	0.0
3		0.0	0.0	1.0	0.0
mean 24-72h		0.0	0.0	0.9	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not provoke an irritating response in the test model. The test material does not fulfill the criteria for classification and labelling according to EU regulation 1272/2008.

Executive summary:

In this guideline (Federal Register 38, No. 187, §1500.41, S. 27019) study conducted prior to GLP adoption, the test material (EC 239-263-3), was found to be non-irritating to the rabbit eye. The test was conducted in three female rabbits. The test material did not fulfill the criteria for classification as an eye irritant according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).