Registration Dossier
Registration Dossier
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EC number: 236-124-9 | CAS number: 13177-41-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.40 bis (in vitro skin corrosion: Human skin model test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Frey-Tox GmbH, Osteroda 38, 04916 Herzberg (Elster)
Test material
- Reference substance name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- EC Number:
- 236-124-9
- EC Name:
- Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide
- Cas Number:
- 13177-41-8
- Molecular formula:
- C23H49NO3S
- IUPAC Name:
- dimethyl(octadecyl)(3-sulfopropyl)azanium hydroxide
- Test material form:
- solid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- 25 mg ± 2.5 mg of the test item were applied together with 25 µL demineralised water
- Duration of treatment / exposure:
- 3 min, 1 h
- Observation period:
- measurement directly following after treatment
- Number of animals:
- 2 replicates of tissue from epidermis skin model EpiDerm
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 101.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 105.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the in vitro study the test is classified as non-corrosive according to the OECD guideline 431.
- Executive summary:
Two tissues of the human skin model EpiDermTM were treated with the test substance for 3 minutes and 1 hour, respectively. Demineralised water was used as negative control and 8 M KOH was used as positive control.
After treatment with the negative control, the absorbance values were within the required acceptability criterion. The positive control showed clear corrosive effects for both treatment intervals.
After 3 minutes treatment with the test substance, the mean value of relative tissue viability was increased to 101.5%. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was increased to 105.1%. This value, too, is above the threshold for corrosion potential (15%).
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