Ethyl 2-methylbut-3-enoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-08-04 to 2009-09-02; day of application: 2009-09-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 431 (“In vitro Skin Corrosion: Human Skin Model Test”), 2004-04-13

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Guideline 440/2008 (Part B: Methods for the determination of toxicity and other health effects: In Vitro Skin Corrosion: Human Skin Model Test; Official Journal of the European Union, No. L 142), 2008-05-30

Deviations:

no

Principles of method if other than guideline:

In addition, the study follows the test strategy for determination of a corrosive/irritant property as given in the following guideline:
- OECD Guideline for Testing of Chemicals No. 404, April 24, 2002 (“Acute Dermal Irritation/Corrosion”).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ethyl (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate

EC Number:

700-224-5

Cas Number:

1647-12-7

Molecular formula:

C7 H12 O2

IUPAC Name:

ethyl (2R)-2-methylbut-3-enoate; ethyl (2S)-2-methylbut-3-enoate

Details on test material:

- Name of test material (as cited in study report): 2-Methylbuten-3-säureethylester
- Physical state: liquid
- Analytical purity: 99.2 wt%
- Lot/batch No.: 34649/199/Fr.3
- Stability under test conditions: the stability under storage conditions over the study period was guaranteed by the manufacturer.
- Other: pH value of the undiluted test substance: ca. 5

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

single topical application of 50 µl (corrosion test) or 30 µl (irritation test)

Duration of treatment / exposure:

3 minutes, 1 hour (corrosion test)
1 hour followed by a 42-hour post-incubation period (irritation test)

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: irritation in vitro

Remarks on result:

other:

Remarks:

Remarks: An irritant potential of the test substance was observed in the EpiDerm™ skin corrosivity test.. (migrated information)

In vivo

Irritant / corrosive response data:

The EpiDerm™ skin corrosivity/irritation test showed the following results:

Direct MTT reduction:
The test item is not able to reduce MTT directly.

Corrosion test:
The mean viability of the test-item treated tissues determined after an exposure period of 3 minutes was 111%, and it was 43% after an exposure period of 1 hour.

Irritation test:
The mean viability of the test-item treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 7%.

For details see attached files.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Conclusions:

Based on the observed results and applying the evaluation criteria, it was concluded that 2-Methylbuten-3-säureethylester shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.