Registration Dossier
Registration Dossier
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EC number: 224-537-7 | CAS number: 4402-32-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted: July 29, 2016
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-diethylaminopropan-2-ol
- EC Number:
- 224-537-7
- EC Name:
- 1-diethylaminopropan-2-ol
- Cas Number:
- 4402-32-8
- Molecular formula:
- C7H17NO
- IUPAC Name:
- 1-(diethylamino)propan-2-ol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent no treatment
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl - Duration of treatment / exposure:
- 3-minute and 60-minute exposures were conducted
- Number of replicates:
- duplicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minute exposure
- Run / experiment:
- 1
- Value:
- 14.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minute exposure
- Run / experiment:
- 2
- Value:
- 23.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3-minute exposure
- Run / experiment:
- mean
- Value:
- 19.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60-minutes exposure
- Run / experiment:
- 1
- Value:
- 7.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60-minutes exposure
- Run / experiment:
- 2
- Value:
- 9.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60-minutes exposure
- Run / experiment:
- mean
- Value:
- 8.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The ability of 1-Diethylaminopropan-2-ol to induce skin corrosion was investigated by using EpiDerm™SCT (EPI-200).
As a result of the skin corrosion test in the 3-minute and 60-minute exposures, the tissue viabilities treated by the test substance were 19.4% and 8.5%, respectively.
Consequently, it was concluded that 1-Diethylaminopropan-2-ol is "Corrosive" (UN GHS Category 1A) under the present test conditions.
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