Ethyl 2-methylbut-3-enoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to current generally accepted scientific standards, comparable to guideline study; study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: in vitro HETCAM

Deviations:

yes

Remarks:

draft guideline

Principles of method if other than guideline:

There are no official guidelines for the HET-CAM Test; however, the study was conducted according to the following publications:
- Lüpke NP (1985). Hen’s Egg Chorio allantoic Membrane Test for Irritation Potential. Fd Chem Toxic 23: 287–291.
- Spielmann H (1995). HET-CAM Test. In: Methods in Molecular Biology 43 (eds.: O’Hare S and Atterwill CK): 199–204.
- Spielmann H et al (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24: pp. 741–858.
In addition the study follows the testing strategy for determination of eye irritation/corrosion as given in the following guideline:
- OECD Guideline for Testing of Chemicals No. 405, April 24, 2002 (“Acute Eye 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 animals / tissue source

Species:

other: hen egg

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

unchanged (no vehicle) or olive oil

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 ml per egg of the undiluted test substance or of a 10% (w/w) solution
- Concentration (if solution): undiluted or 10% (w/w)

Duration of treatment / exposure:

single dose, observation for 160 seconds

Observation period (in vivo):

160 seconds

Number of animals or in vitro replicates:

3 eggs per test concentration

Results and discussion

In vivo

Results

Irritation parameter:

other: effect on chorioallantoic membrane

Basis:

other: coagulation, haemorrhagia

Time point:

other: up to 160 seconds

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks:

No coagulation or haemorrhaia with the 10% in olive oil (not corrosive)

Remarks on result:

other: No effects with a 10% solution of the test substance in olive oil; coagulation and hemorrhagia with the unchanged test substance.

Irritant / corrosive response data:

The chorioallantoic membrane of the eggs treated with the 10% test-item solution in olive oil did not show any irritation effects.
The undiluted test item caused moderate intravascular coagulation and slight haemorrhagia in all eggs after 36 – 40 seconds.
For details see attached files.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Based on the results of this study and applying the evaluation criteria, it is concluded that 2-Methylbuten-3-säureethylester causes serious eye damage in the HET-CAM Test under the test conditions chosen.