Registration Dossier
Registration Dossier
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EC number: 241-503-7 | CAS number: 17496-08-1
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:
- 2 017
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium propionate
- EC Number:
- 241-503-7
- EC Name:
- Ammonium propionate
- Cas Number:
- 17496-08-1
- Molecular formula:
- C3H6O2.H3N
- IUPAC Name:
- ammonium propionate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3 minutes and 1 hour
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- One hour
- Value:
- ca. 9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- ca. 78.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Test item showed a slight reduced potential of cell viability in comparison to the negative control only after 1 hour application time. The mean viability of test item’s two replicates results was 78.6% of the mean negative control value at 3 minutes application time and 9.0% at 1 hour application time.
Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid and qualified.
In this in vitro skin corrosion test with the EpiDermTM model on test item “Ammonium propionate (CAS: 17496-08-1; EC:241-503-7) in aqueous solution (50-55 %)” results indicated that the test item is Corrosive (Sub-Category 1B/1C).
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