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Toxicological information

Skin irritation / corrosion

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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:
2017
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

Constituent 1
Chemical structure
Reference substance name:
1-(2-bromoethoxy)-2-methoxybenzene
EC Number:
402-010-4
EC Name:
1-(2-bromoethoxy)-2-methoxybenzene
Cas Number:
4463-59-6
Molecular formula:
C9H11BrO2
IUPAC Name:
1-(2-bromoethoxy)-2-methoxybenzene
Details on test material:
- Name of test material (as cited in study report): Carvedilol 5th intermediate (Bromoethoxy-guaiacol)
- Physical state: reddish brown crystalline powder
- Lot/batch No.: 9803
- Expiration date of the lot/batch: June 2001
- Storage condition of test material: at room temperature

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
SKIN DISC PREPARATION
- Procedure used: EpiSkin SM kit
- Quality control for skin discs: certified ISO 9001

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment- exposure: room temperature

DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: 96-well plate spectrophotometer
- Wavelength: 570 nm
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 mikroliter
- Concentration (if solution): 100%

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 mikroliter
- Concentration (if solution): 100 %
Duration of treatment / exposure:
4 hours
Number of replicates:
2

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
86
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: no skin corrosion potential

Applicant's summary and conclusion

Interpretation of results:
other: Non-corrosive
Conclusions:
The results obtained from this in vitro skin corrosion test, using the EPISKIN model, indicated that the test item reveals no skin corrosion potential under the utilised testing conditions. In conclusion, the test item Bromethoxy-qvajacol (CVD 21) can be classified as Non-corrosive.