Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 March 2002 - 22 March 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An in vivo study was performed at 2002.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

EC Number:

228-536-2

EC Name:

Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate

Cas Number:

6290-17-1

Molecular formula:

C9H16O4

IUPAC Name:

ethyl 2-(2,4-dimethyl-1,3-dioxolan-2-yl)acetate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

other: Albino rabbits (Chbb:HM)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: stock Chbb:HM(SPF) - Littlerussian, BI Pharma KG
- Age at study initiation: not indicated
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: complete rabbit diet "Altromin 2123" from Altromin, ad libitum
- Water: free access to bottles with domestic quality drinking water acidified
with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: no

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55 % ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not indicated

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Ethanol/Diethylphthalate 1:1

Controls:

yes, concurrent vehicle

Amount / concentration applied:

0% (vehicle), 1%, 10%, 25%, 50% and 100% (v/v) in the vehicle.
0.5 mL of the test substance or vehicle was applied.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: adhesive Gothaplast tape

REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 1 hour, 24 hours, 48 hours and 72 hours after termination of exposure.

SCORING SYSTEM: according to the scale shown in table 1 and 2 ('Any other information on materials and methods, incl. tables').

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

1, 24, 48 and 72 hours after the termination of exposure none of the animals showed skin reactions.

Applicant's summary and conclusion

Interpretation of results:

other: Not a skin irritant

Remarks:

According to EU CLP (EC. No. 1272/2008 and its amendments).

Conclusions:

Under the experimental conditions described in this report, no skin irritation was observed in rabbits after exposure to the substance.

Executive summary:

In this study performed according to OECD TG 404 guideline and GLP principles, 4 female rabbits were observed for skin irritation after exposure to the substance. Concentrations of 0% (EtOH/DEP, vehicle), 1%, 10%, 25%, 50% were tested with vehicle and 100% (v/v) was used undiluted. An amount of 0.5 mL substance was applied to clipped skin with a surface of 2.5 x 2.5 cm. After 4 hours of exposure, the substance was removed and the skin was washed. Observations were made for 72 hours after exposure. The animals were scored for erythema and oedema formation. No skin irritation was observed and the mean erythema and oedema scores for all animals were 0. Based on the results, the substance is considered not to be a skin irritant and does not need to be classified for skin irritation according to Regulation (EC) No. 1272/2008 and its amendments.