2-(4-bromophenyl)-2-methylpropionic acid methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with validated guidelines and in GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-bromophenyl)-2-methylpropionic acid methyl ester

EC Number:

450-630-9

EC Name:

2-(4-bromophenyl)-2-methylpropionic acid methyl ester

Cas Number:

154825-97-5

Molecular formula:

C11H13BrO2

IUPAC Name:

methyl 2-(4-bromophenyl)-2-methylpropanoate

Test material form:

other: liquid

Details on test material:

The test material was a colourless oil of FEXO-03 with a degree of purity >95%.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The age at treatment of the Rabbit was 10 weeks for male and 13-14 weeks for females. The Rabbit was placed under laboratory conditions after healt examinations. Only animals without any visual signs of illness were used for the study.
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70% and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of
12 hours light and 12 hours dark. Music was played during the daytime light period.
Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4646 were provided for gnawing. Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum. Community tap water, ad libitum.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours alter the removal of the dressing, gauze patch and test item.

Number of animals:

3

Details on study design:

Four days before treatment, one flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 mL of FEXO-03 was placed on a surgical gauze patch (ca. 4 cm x 4 cm). This gauze patch was applied to the intact skin of the clipped area. The
patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application sile so that any reactions
(erythema) were clearly visible at that time.
The observation has regarded the viability/mortality, the clinical signs and the body weights.
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 approximately 1, 24, 48 and 72 hours alter the removal of the dressing, gauze patch and test item.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) far each animal for erythema/eschar grades and for oedema grades, separately.
The mean erythema/eschar score and the mean oedema score of the three animals were 0.00.
Very slight erythema was observed in one animai at the 1-hour reading. No swelling (oedema) was noted in any animal at any time.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

Coloration : no staining of the treated skin by the test item was observed.
Body weight : within the normal range of variability

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

FEXO-03 is considered to be "not irritating" to rabbit skin.