2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22.10.2009 to 02.12.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester

EC Number:

611-390-2

Cas Number:

56467-43-7

Molecular formula:

C17H14O3

IUPAC Name:

2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester

impurity 1

Reference substance name:

(4-benzoylphenyl) acetate

Cas Number:

13031-44-2

Molecular formula:

C15H12O3

IUPAC Name:

(4-benzoylphenyl) acetate

Test material form:

solid

Specific details on test material used for the study:

4-(Methacryloyloxy) bezophenone 97.26 %
Benzophenone acetate: 1.95 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Healthy New Zealand White Rabbits, Crl: KBL (NZW)

Details on test animals or test system and environmental conditions:

Test System
Species/strain: Healthy New Zealand White Rabbits, Crl: KBL (NZW)
Source: Charles River Deutschland, D-97633 Sulzfeld
Sex: female
Body weight at the beginning of the study:> 2 kg
Age at the beginning of the study: approximately 15 weeks old
Number of animals: 3
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Housing and Feeding Conditions
Semi barrier in an air-conditioned room
Temperature: 18 ± 3°C (recommendations ofTVT, GV-SOLAS
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least I 0 x / hour
Free access to autoclaved hay and toAltromin 2123 maintenance diet for rabbits (lot no. 1411 ), rich in crude fibre
Free access to tap water (drinking water, municipal residue control, microbial. controlled periodically)
Housed in ABS -plastic rabbit cages, floor 4200 cm2
Adequate acclimatisation period (at least 5 days)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: The untreated right side served as control.

Amount / concentration applied:

0.5 g per test site

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3

Details on study design:

Preparation of the Animals:
Approximately 24.5 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.

Initial Test (in vivo Dermal Irritation/Corrosion Test using one Animal):
The test item was not expected to produce corrosion but might be irritating. Therefore, a single patch was applied to one animal for 4 hours.

Application:
The test item was applied first to a gauze patch at a single dose. To ensure good skin contact, it was moistened with aqua ad injectionem (B. Braun Melsungen, lot no. 7494Al91, expiry date: 1112010). The patch was then applied to the skin on a small area ( approx. 6 cm2 ) on the left side of the dorsal area. The gauze was held in place with non-irritating tape. The untreated right side served as control. The patch was fixed with a semi-occlusive dressing. The limits of the application site were marked with an ink marker.

Dose Level:
A dose of 0.5 g of the test item was applied to each test site.

Exposure Period:
The test item was held in contact with the skin throughout a 4-hour period. At the end of the exposure period the residual test item was removed by using aqua ad injectionem.

Confirmatory Test:
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the skin using the procedure described. In order to confirm the response,
two additional animals were treated in the same manner.

Observation Period:
All animals were observed for 72 hours after the patch removal.

Clinical Observation
For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 1 hour as well as 24, 48 and 72 hours after patch removal. Dermal irritation was scored and recorded according to the grades inthe table below. Any other signs such as hyperplasia, scaling,
discoloration, fissures and scabs or any systemic effects were also recorded. For the initial test in one animal, the test site was also examined immediately after the patch has been removed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

There were no significant body weight changes during the contact and observation period

Any other information on results incl. tables

  Dermal irritation evaluation:

		Irritation (hours after patch removal)
Animal No.	Appl. site	1 hour		24 hours		48 hours		72 hours
		erythema	oedema	erythema	oedema	erythema	oedema	erythema	oedema
1	Test item	0	0	0	0	0	0	0	0
	control	0	0	0	0	0	0	0	0
2	Test item	0	0	0	0	0	0	0	0
	control	0	0	0	0	0	0	0	0
3	Test item	0	0	0	0	0	0	0	0
	control	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, single dermal application of the test item 4-(Methacryloyloxy)benzophenone to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item 4-(Methacryloyloxy)benzophenone does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

In an acute dermal irritation/corrosion study acc. OECD 404 with 4-(Methacryloyloxy) benzophenone by single dermal application to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item

4-(Methacryloyloxy)benzophenone does not have to be classified and has no obligatory labelling requirement for skin irritation.