Methyl 3-methyl-2-butenoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EG Guideline B.4 Akute Toxizität Hautreizung der Richtlinie 84/449/EWG

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Richtline 83/467/EWG

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-Methylcrotonsäuremethylester

IUPAC Name:

3-Methylcrotonsäuremethylester

Constituent 2

Reference substance name:

Methyl 3-methyl-2-butenoate

EC Number:

213-107-4

EC Name:

Methyl 3-methyl-2-butenoate

Cas Number:

924-50-5

Molecular formula:

C6H10O2

IUPAC Name:

methyl 3-methylbut-2-enoate

Test material form:

other: clear liquid

Details on test material:

Purity: 97.3 %, storage: 22°C dark under the hood,

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

BW: 2,1-2,8 kg, Age: 3-5 months, single housing, room temperatur: 20 +/-3 °C, Humidity: 50+/- 20%, Light/dark: 12/12h , Feeding: Altromin 2123 Haltungsdiet Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum and hay (15 g daily), chlorinated water (ad libitum), Source: Hoechst AG, Kastengrund, fully air conditioned, single housing, ID: ear marked,

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 animals per group

Details on study design:

The animals were shaved (with an electronic shaver; 25 m2 dorsal of the hull) 24 hours before the experiment was accomplished.Only animals with
an intact skin were used. Every animal was patched with a plaster and a 2.5x2.5 cm cellulose. Under the plaster 0.5 ml of the substance (not diluted) was administered and ligated with a semiocclusive bandage. The exposure time was 4 h . After exposure the substance was removed with lukewarm water. The examination followed after 30-60 minutes, 24h, 48 h and 72 h, 7, 14 and 21 days after the plaster was removed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

0

Other effects:

One animals showed dry skin.

Any other information on results incl. tables

See: (attached background material)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to the skin.

Executive summary:

30 min and 48h after the plaster was removed erythema were diagnosed (in all animals) . One animal had a clear visible erythema after 72 h plus a dry and rough skin. After 7 days all irritation symptoms were reversible.Only one animal showed a dry and rough skin surface after 7 days.

It can be concluded that the test item is not irritating to the skin.