Registration Dossier
Registration Dossier
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EC number: 478-080-5 | CAS number: 57043-35-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2003 - January 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- Adopted 19 July 2006
- Deviations:
- no
- Principles of method if other than guideline:
- Corrositex test is a standardized and reproducible method that can be employed to determine potential corrosivity and determine the Packing Group classification of specified categories of chemical compounds under the hazardous materials transportation regulations administered by the U.S. Department of Transportation (DOT) and international dangerous goods codes. The Corrositex test predicts the in vivo corrosive potential or a chemical compound or mixture by using as an endpoint the time it takes for the chemical to permeate through or destroy a synthetic biobarrier. When the chemical has passed through this biobarrier, a visual change is produced in a proprietary Chemical Detection System (CDS).
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 478-130-6
- EC Name:
- -
- Cas Number:
- 50940-49-3
- Molecular formula:
- C9H12O6
- IUPAC Name:
- 2-(acryloyloxy)ethyl hydrogen succinate
- Reference substance name:
- -
- EC Number:
- 478-080-5
- EC Name:
- -
- Cas Number:
- 57043-35-3
- Molecular formula:
- C13H18O6
- IUPAC Name:
- 2-{[2-(prop-2-enoyloxy)ethoxy]carbonyl}cyclohexane-1-carboxylic acid
- Test material form:
- liquid
- Details on test material:
- Sample 51032A: 25% MAES - 75% MAHP
Sample 51032B: 50% MAES - 50% MAHP
Sample 51032C:75% MAES - 25% MAHP
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Sample 51032A: 25% MAES - 75% MAHP
Sample 51032B: 50% MAES - 50% MAHP
Sample 51032C:75% MAES - 25% MAHP
In vitro test system
- Test system:
- artificial membrane barrier model
- Details on test system:
- TYPE OF MEMBRANE BARRIER TEST USED:
- was the Corrositex® test kit used: yes
- was the compatibility test performed: yes
- was the timescale category test performed: yes, classified as Category 2 material
- temperature used during treatment: not specified, probably at room temperature.
- method of detection: CDS reagent
- method of application: neat
- number of replicates: 4 per sample
- prediction model / decision criteria: The test substance is considered to be corrosive to skin if < 60 minutes elapsed between application of the test substance to the membrane barrier and barrier penetration. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 100% sample
- Duration of treatment / exposure:
- > 60 minutes
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 4 per sample, 3 samples
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Sample 51032A
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Sample 51032B
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Sample 51032C
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The results of these studies indicated that the samples were compatible with the Corrositex system and were classified as Category 2 material. The results obtained from the evaluation of three different samples with four replicates per sample were highly reproducible, demonstrating that mean time of > 60 minutes was required to destroy the synthetic biobarriers. These findings lead to the designation of these samples containing different ratio's of MAHP and MAES as a non-corrosive. To confirm the non-corrosivity, an additional in-vivo test was scheduled.
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