Methyl benzoylformate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No. 187, §1500.41, S. 27029

Version / remarks:

1973

Deviations:

yes

Remarks:

Exposure period extended to 24 hours, no scoring at 48 hour observation, and observation period shortened to 8 days.

Principles of method if other than guideline:

2 animals were tested applying the test substance for 5 min and 2 hours under occlusive conditions, respectively. The test substance was rinsed with Lutrol and observed after 24, 48 hours and 8 days.

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean: female: 3.44 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

5min, 2h or 24 hours

Observation period:

24, 72 hours and 8 days

Number of animals:

3 (24h exposures)
2 (5min and 2h exposure)

Details on study design:

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 1

Time point:

other: 24, 72 hours

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal 1

Time point:

other: 24, 72 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 2

Time point:

other: 24, 72 hours

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal 2

Time point:

other: 24, 72 hours

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 3

Time point:

other: 24h, 72 hours

Score:

2.5

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: intact skin (24h exposure), 48h reading was not taken due to study design and age of the study.

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal 3

Time point:

other: 24, 72 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: intact skin (2h exposure), 48h reading was not taken due to study design and age of the study.

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 4

Time point:

24/48 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal 4

Time point:

24/48 h

Score:

0

Max. score:

0

Remarks on result:

other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.

Results 9

Irritation parameter:

erythema score

Basis:

mean

Remarks:

Animal 5

Time point:

24/48 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

Animal 5

Time point:

24/48 h

Score:

0

Max. score:

0

Remarks on result:

other: 2 hour exposure, 72h reading was not taken due to study design and age of the study.

Other effects:

Scaling was found in all animals on day 8 of observation.

Any other information on results incl. tables

Results for 24h exposure:

	reading time	animal 1	animal 2	animal 3
erythema
intact skin	24h	2	2	2
	72h	3	2	3
	8d	2 S	0 S	2 S o
	mean 24,72h	2.5	2	2.5
abraded skin	24 h	3	3	2
	72h	3	3	3 o
	8d	2 S	1 S	2 sS o
	mean 24,72h	3	3	2.5
edema
intact skin	24 h	2	0	2
	72h	2	1	2
	8d	0	0	0
	mean 24,72h	2	0.5	2
abraded skin	24 h	2	2	2
	72h	3	3	3 o
	8d	0	0	0
	mean 24,72h	2.5	2.5	2.5

S: scaling; sS: strong scaling; overall

Results for internal method: After 2 hour exposure with the test substance to the skin of two rabbits erythema of score 1 was observed 24 hours later. This effect was fully reversible within 48 hours (score 0). 8 days after application scaling was still observed. No edema was observed at any reading time point.

Exposure Time	Animal No.	1. Redness - Corossion			2. Oedema
		24 hrs	48 hrs	8 Days	24 hrs	48 hrs	8 Days
2 hrs	1	1	0	0 S	0	0	0
	2	1	0	0 S	0	0	0

S = scaling

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material achieved mean erythema scores in 2 of 3 test animals of 2.5 each after a 24 hour occlusive exposure. After a 2 hour expsoure the test material achieved a mean erythema score of 0.5 in both animals tested, fully reversible within 8 days. Due to the non-standard exposure period, the test material is considered not to fulfill the criteria for skin irritation under EU regulation 12772/2008.

Executive summary:

In this guideline study (Federal Register 38, No. 187, §1500.41, S. 27029; 1973) the test material was tested twice with exposure times of 24 hours and 2 hours. After the 24 hour exposure period, the test material achieved mean erythema scores in 2 of 3 animals of 2.5 each. After the 2 hour exposure, the test material achieved a mean erythema scores in both test animals of 0.5, reversible in 8 days. As the standard exposure period is 4 hours, the test material is considered not to meet the criteria cor skin irritation classificaiton according to EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).