Registration Dossier
Registration Dossier
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EC number: 944-951-8 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.
Test material
- Reference substance name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Cas Number:
- 190445-18-2
- Molecular formula:
- C9H19NO7
- IUPAC Name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Reference substance name:
- gluconic acid, aminopropanol salt
- Molecular formula:
- C9 H21 N1 O8
- IUPAC Name:
- gluconic acid, aminopropanol salt
- Test material form:
- liquid
- Remarks:
- 50% solution in water
- Details on test material:
- % solids in water: 48.0 - 52.0
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Chemical name: Samson
Code: S18+
CAS number: -
Batch number: -
Purity: not specified
Physical state: Liquid
Storage conditions: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Description: Ashland 0.5 cm2 reconstructed epidermis from normal human keratinocytes. Cells are grown on inert polycarbonate filter on chemically defined medium. airlifted for 17 days.
Batch N°: 1503EPID03
Origin: Foreskin
Quality Controls: Certified by Ashland Tissue Engineering laboratories. April 6, 2015 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 100%
- Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours, duration of MTT incubation: 3 hours
- Number of replicates:
- 9
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Viability (%)
- Value:
- >= 90.3 - <= 95.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Viability 87 to 107%
- Positive controls validity:
- valid
- Remarks:
- Viability < 2%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the In-Vitro Skin Irritation by the Ashland Epidermis Equivalent (Aee) Test Method reaction mass of hydroxylpropyl gluconamide and hydroxypropyl ammonium gluconate is classified as Non Irritant.
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