Phenyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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)

Version / remarks:

adopted 24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phenyl methacrylate

EC Number:

218-542-3

EC Name:

Phenyl methacrylate

Cas Number:

2177-70-0

Molecular formula:

C10H10O2

IUPAC Name:

phenyl 2-methylprop-2-enoate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Phenyl methacrylate

Test animals

Species:

rabbit

Strain:

other: New Zealand White (Hsdlf:NZW)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.34 to 2.69 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

3 min, 1, 4 h in first animal; 4 h in second animal

Observation period:

1, 24, 48, 72 h

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patches secured with surgical adhesive tape + wrapped in an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after patch removal: 3 min, 1, 4 h in first animal; 4 h in second animal

SCORING SYSTEM: as stipulated in OECD guideline 404 (Draize scale)

On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.
After consideration of the skin reactions produced in the first animal, an additional animal was treated with 0.5 ml of test item. One patch was applied to the back of the rabbit and was allowed to remain in contact with the skin for a period of four hours.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema observed

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No irritation observed

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No edema observed

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

3 min exposure:
very slight erythema was noted at the treated skin site immediately and 1 h after patch removal

1 h exposure:
very slight erythema was noted at the treated skin site immediately and 1 h after patch removal

4 h exposure:
very slight erythema was noted at one treated site immediately after patch removal, at both treated sites 1 h after patch removal and at one treated site at the 24 h observation; all effects were fully reversible within 48 h

No corrosive effects were noted.

Other effects:

Both animals showed the expected body weight gains during the study period.

Any other information on results incl. tables

 

Skin reaction	Animal 1
	score after 0/1/24/48/72 h
3 min exposure
Erythema/eschar (max. score 4)	1/1/0/0/0
Edema (max. score 4)	0/0/0/0/0
1 h exposure
Eeythema/eschar (max. score 4)	1/1/0/0/0
Edema (max. score 4)	0/0/0/0/0

 

 

Skin reaction	Animal 1	Animal 2
	score after 0/1/24/48/72 h	score after 0/1/24/48/72 h
4 h exposure
Erytheme/eschar (max score 4)	1/1/1/0/0	0/1/0/0/0
Edema (max. score 4)	0/0/0/0/0	0/0/0/0/0

 

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

PHMA is not irritating to rabbit skin.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404, adopted 24 April 2002, 2 male 12 to 20 weeks old New Zealand white rabbits were dermally exposed to 0.5 mL of PHMA (99.6% a.i.) for 4 h to 2.5 cm x 2.5 cm body surface area. In one of the animals additional patches were applied, which were removed after 3 min and 1 h. Animals then were observed for 3 days. Irritation was scored by the Draize method (OECD guideline 404).

3 min and 1 h semi-occluded applications of the test item to the intact skin of one rabbit produced very slight erythema (grade 1) immediately and 1 h after patch removal.

After 4 h exposure very slight erythema (grade 1) was noted at one treated site immediately after patch removal, at both treated sites 1 h after patch removal and at one treated site at the 24 h observation. All effects were fully reversible within 48 h.

No corrosive effects were noted.

PHMA was not irritating in this dermal irritation study.