Registration Dossier
Registration Dossier
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EC number: 700-225-0 | CAS number: 1160806-44-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-09-01 to 2009-09-16; day of application: 2009-09-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (“In vitro Skin Corrosion: Human Skin Model Test”), 2004-04-1
- Deviations:
- no
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008
- Deviations:
- no
- Principles of method if other than guideline:
- The corrosion study was conducted according to the following test guidelines:
- OECD Guideline for Testing of Chemicals No. 431, April 13, 2004 (“In vitro Skin Corrosion: Human Skin Model Test”)
- Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 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
The irritation study was conducted based on the following draft test guideline:
- OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008. Available at http://www.oecd.org - GLP compliance:
- yes (incl. QA statement)
Test material
- 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: semi-solid
- 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.
Constituent 1
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:
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 142%, and it was 98% 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 5%.
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-Methyl-3,4-dibrombuttersäureethylester shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
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