Reaction mass of ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-08-18 to 2009-09-16; day of application: 2009-08-27

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: HETCAM

Deviations:

yes

Remarks:

in vitro HETCAM

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,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate

EC Number:

700-225-0

Cas Number:

1160806-44-9

Molecular formula:

C7 H12 Br2 O2

IUPAC Name:

ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate; ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate

Details on test material:

- Name of test material (as cited in study report): 2-Methyl-3,4-dibrombuttersäureethylester
- Physical state: liquid
- Analytical purity: 98.1 wt% (according to the supplier)
- Lot/batch No.: 35684-12-5
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the manufacturer.
- Other: pH value: ca. 4.5 (undiluted test substance)
No further data.

Test animals / tissue source

Species:

other: hen egg

Test system

Vehicle:

other: unchanged (no vehicle) or olive oil

Amount / concentration applied:

- 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 sec

Number of animals or in vitro replicates:

3 eggs per concentration

Results and discussion

In vivo

Results

Irritation parameter:

other: effect on chorioallantoic membrane

Basis:

other: haemorrharia, coagulation

Time point:

other: 90 -160 sec

Score:

0

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: No effects on chorioallantoic membrane were observed.

Irritant / corrosive response data:

The chorioallantoic membrane of all eggs did not show any irritation effects.
Historical control values of positive controls, gathered over an appropriate time period, demonstrate the reproducibility of results and robustness of the procedures.
For details, see attached files.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information not corrosive

Conclusions:

Based on the results of this study and applying the evaluation criteria, it is concluded that 2-Methyl-3,4-dibrombuttersäureethylester does not produce changes indicative for serious eye damage in the HET-CAM Test under the test conditions chosen.
The test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test item. For final assignment of a risk phrase at present, results from an in vivo study would be needed.