Registration Dossier
Registration Dossier
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EC number: 204-620-4 | CAS number: 123-34-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12-13 October 2017
- 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: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- the epidermis units were incubated with MTT for 2 hours 1 minute instead of 3 hours (± 15 min)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(allyloxy)propane-1,2-diol
- EC Number:
- 204-620-4
- EC Name:
- 3-(allyloxy)propane-1,2-diol
- Cas Number:
- 123-34-2
- Molecular formula:
- C6H12O3
- IUPAC Name:
- 3-(allyloxy)propane-1,2-diol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Adult humanderived epidermal keratinocytes are seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
- Details on test system:
- Kit Contents
Units: EPISKINTM(SM) plate containing up to 12 reconstructed epidermis units (area: 0.38 cm2) each reconstructed epidermis is attached to the base of a tissue culture vessel with an O-ring set and maintained on nutritive agar for transport.
Plate: 12-well assay plate
Punch: EPISKINTM(SM) biopsy punch for easy sampling of epidermis
Medium: A flask of sterile “Maintenance Medium” (Batch No.: 17 MAIN3 043; Exp. Date: 18 October 2017)
A flask of sterile “Assay Medium” (Batch No.: 17 ESSC 040; Exp. Date: 18 October 2017) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 μL
- Duration of treatment / exposure:
- 4 hours
- Duration of post-treatment incubation (if applicable):
- 4 hours
- Number of replicates:
- 2 replicates each for test item, negative control and positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 88
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-corrosive to the skin
- Executive summary:
The skin corrosivity has been assessed using the EPISKIN model test according to the OECD 431. The tissue viability was 88% and the substance is therefore non-corrosive.
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