Registration Dossier
Registration Dossier
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EC number: 212-142-2 | CAS number: 765-30-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 23,1997-April 29,1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SOP No. CB 230 (CORROSITEX Testing Procedure) and "The CORROSITEX Instrucation Manual,DOT-E 10904"
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclopropylamine
- EC Number:
- 212-142-2
- EC Name:
- Cyclopropylamine
- Cas Number:
- 765-30-0
- Molecular formula:
- C3H7N
- IUPAC Name:
- cyclopropanamine
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Number of replicates:
- 4
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 3.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Executive summary:
The CORROSITEX Assay is an in vitro method which can be used to estimate the dermal corrosivity potential of a test substance. In this assay, the time it takes for Cyclopropylamine to produce alterations or destruction of an artificial barrier composed of soluble collagen is used to predict corrosivity. The barrier penetration time is detected by a color change, flaking, or precipitate formation in a chemical detection system located on the opposite side of the artificial barrier.
The mean CORROSITEX Time for Cyclopropylamine was 3 min. 25 sec.,accorrding to which the test substance can be classified as Category 1B.
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