2-methyl-4-phenyl-1,3-dioxolane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 Nov - 24 Nov 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 Jul 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-4-phenyl-1,3-dioxolane

EC Number:

251-752-3

EC Name:

2-methyl-4-phenyl-1,3-dioxolane

Cas Number:

33941-99-0

Molecular formula:

C10H12O2

IUPAC Name:

2-methyl-4-phenyl-1,3-dioxolane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.73-3.02 kg
- Housing: animals were housed individually in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services LTD, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: minimum 5 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

3 min and 1 and 4 h (one animal)
4 h (two animals)

Observation period:

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: area on the back
- Type of wrap: The test substance was applied to the skin and covered with gauze patch (2.5 cm x 2.5 cm). The patch was secured in position with a strip of surgical adhesive tape (BLENDERM, 2.5 cm x 4.0 cm). Additionally, the trunk was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 3 min and 1 and 4 h (one animal); 4 h (two animals)

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: loss of skin elasticity after 72 h, slight desquamation after 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites at the 1 h observation and at two treated skin sites at the 24, 48 and 72 h observations. Very slight oedema was noted at all treated skin sites at the 1 h observation, at two treated skin sites at the 24 h observation and at one treated skin site at the 48 and 72 h observations. Loss of skin elasticity was noted at two treated skin sites at the 72 h observation. Slight desquamation was noted at two treated skin sites after 7 days.
One treated skin site appeared normal at the 24-hour observation.

3 min exposure period: No evidence of skin irritation was noted during the study.

1 h exposure period: Very slight erythema was noted at the treated skin site at the 24, 48 and 72 h observations. Loss of skin elasticity was noted at the treated skin site at the 72 h observation. Slight desquamation was noted at the treated skin site after 7 days..

Any other information on results incl. tables

Table 1. Results of the skin irritation study following 4 h exposure.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	1	1	1	1	1
24 h	1	1	0	0	1	1
48 h	1	1	0	0	1	0
72 h	1^LE	1	0	0	1^LE	0
7 days	0^D		0	0	0^D	0
Mean value 24 + 48 + 72 h	1.00	1.00	0	0	1.00	0.33

D: Desquamation (slight)

LE: Loss of skin elasticity

Table 2. Results of the skin irritation study following 3 min and 1 h exposure.

Observation time	Exposure period
	3 min		1 h
	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0
24 h	0	0	1	0
48 h	0	0	1	0
72 h	0	0	1^LE	0
7 days	0	0	0^D	0

D: Desquamation (slight)

LE: Loss of skin elasticity

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.

Executive summary:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight edema. Incidents of loss of skin elasticity were also noted. Slight desquamation was noted at two treated skin sites at the 7-day observation. One treated skin site appeared normal at the 24-hour observation. No corrosive effects were noted. Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.