Registration Dossier
Registration Dossier
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EC number: 612-154-1 | CAS number: 6147-66-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 2021 to April 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- bis(prop-2-en-1-yl)amine hydrochloride
- EC Number:
- 612-154-1
- Cas Number:
- 6147-66-6
- Molecular formula:
- C6H11N.HCl
- IUPAC Name:
- bis(prop-2-en-1-yl)amine hydrochloride
- Test material form:
- liquid
- Remarks:
- Salt dissolved in water
Constituent 1
- Specific details on test material used for the study:
- 66% purity
Aqueous solution
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIN (RHE) TISSUE
Supplier: Episkin Laboratories, Lyon, France
Tissue model: 0.38 cm2 reconstrcuted spidermin of normal keratinocytes
Batch number: 21-EKIN-003
Date received: 19th February 2021
TEMPERATURE USED DURING TREATMENT
Temperature: 37oC
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Viability: Optical Density (O.D) Values: 0.843 +/- 0.008 (mean and SD of MTT value of 3 tissues exposed to negative control). Acceptance criteria (>0.6 and <1.5) - pass - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST ITEM
- used as supplied (neat)
- Volume applied, 10 uL
NEGATIVE CONTROL
- used as supplied (neat)
-Volume applied, 10 uL
POSITIVE CONTROL
- prepared as a 5% w/v aqueous solution.
-volume aplied, 10 uL - Duration of treatment / exposure:
- EXPOSURE PERIOD - 15 minutes
- Duration of post-treatment incubation (if applicable):
- Incubated at 37 oC for 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean value
- Value:
- 108.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
-Visible damage on test system: none reported
- Direct-MTT reduction: No direct reduction
-Colour interference with MTT: No colour interference
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 2-Propen-1-amine, N-2-propen-1-yl-, hydrochloride did not reduce the tissue viability. The test substance does not meet the criteria for classification as irritant to the skin according to Regulation (EC) No. 1272/2008.
- Executive summary:
The in vitro skin irritation of 2-propen-1-amine, N-2-propen-1-yl, hydrochloride was determined in accordance with the OECD Guideline 439 during a GLP compliant study. This in vitro risk assessment assay predicits the skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm tissue model.
Prior to testing, the test substance was checked for interference with water and/or MTT. No interference was identified.
Skin irritation of the test substance and controls was evaluated in triplicate. After 15 minutes exposure on the surface of the EpiDerm resconstructed human epidermis and a 42 hour post-exposure incubation time, viability of the tissues was assessed and compared to the negative control.
The percentage viability obtained with 2-propen-1-amine, N-2-propen-1-yl, hydrochloride was 108.6%, therefore it was considered as non-irritant to the skin according to criteria laid down in OECD guideline 439.
The test item did not meet the criteria for classification as irritant according to Regulation (EC) No. 1272/2008.
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