Registration Dossier
Registration Dossier
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EC number: 210-719-3 | CAS number: 622-08-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-benzyloxyethanol
- EC Number:
- 210-719-3
- EC Name:
- 2-benzyloxyethanol
- Cas Number:
- 622-08-2
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 2-(benzyloxy)ethanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch 170808-29
Exp Date 28/08/2019
Assay > 99%
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
16 +/- 0,5 mcl
NEGATIVE CONTROL
16 +/- 0,5 mcl
POSITIVE CONTROL
16 +/- 0,5 mcl - Duration of treatment / exposure:
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 68.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 439:2015, under the test conditions applied, the test substance is considered NON IRRITANT
- Executive summary:
The test was carried out using reconstructed human epidermis (RHE), in triplicate. The exposure of the insert to the test substance was carried out for 42 in at room temperature.
After treatment the inserts were rinsed with D-PBS and post-incubated with growth medium for additional 42 hours at 37 +/- 1°C, 5 +/-% CO2. Finally, inserts were incubated with MTT solution in oredr to evaluate cell viability which is a direct measure of the irritant potential of the substance. Because of the MTT - reducing interference produced by the test substance, additional testing were performed to evaluate the correct irrititant potential. Under these conditions, the test substance Benzyl Glycol CAS 622 -08 -2 assay >99% resulted NON IRRITANT
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