Registration Dossier

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:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
yes
Remarks:
coefficient of variation of viability of test item treated tissues @3 minutes = 31% = above acceptance criteria- did not affect outcome
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
Identification: 1,3-dichloro-2-propanol
Appearance: Colourless liquid
Batch: ZMG-197685
Purity/Composition: 99.2%
Test item storage: At room temperature container flushed with
nitrogen
Stable under storage conditions until: 09 December 2017 (expiry date)


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:
EpiDerm Skin Model (EPI-200, Lot no.: 26767, Appendix 4).
The model consists of normal, human-derived epidermal keratinocytes which have been
cultured to form a multilayered, highly differentiated model of the human epidermis. It
consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum
containing intercellular lamellar lipid layers arranged in patterns analogous to those found in
vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of
10 mm cell culture inserts.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
50µl per well
Duration of treatment / exposure:
3 minutes and 1 hour
Duration of post-treatment incubation (if applicable):
3 hours for MTT metabolism
Number of replicates:
two tissues per timepoint

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes
Value:
ca. 77
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
ca. 6.4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The test item was checked for color interference in aqueous conditions and possible direct
MTT reduction by adding the test item to MTT medium. Because the solutions did not turn
blue / purple nor a blue / purple precipitate was observed it was concluded that the test item
did not interfere with the MTT endpoint.

The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative
control tissues was 77% and 6.4% respectively. Because the mean relative tissue viability for
the test item was below 15% after 1 hour treatment it is considered to be corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was
within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance
limit <=2.8) and the laboratory historical control data range. The mean
relative tissue viability following the 1-hour exposure to the positive control was 9.2%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was
<= 16% for the negative control, indicating that the test system functioned properly

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In conclusion, 1,3-dichloro-2-propanol is corrosive in the in vitro skin corrosion test under the
experimental conditions described in this report.
Executive summary:

The objective of this study was to evaluate 1,3-dichloro-2-propanol for its ability to induce

skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)).  The

possible corrosive potential of the test item was tested through topical application for

3 minutes and 1 hour.

The study procedures described in this report were based on the most recent OECD and EC

guidelines.

Batch ZMG-197685 of the test item was a colourless liquid. The test item was applied

undiluted (50 µl) was applied directly on top of the skin tissue.  

The positive control had a mean relative tissue viability of 9.2% after the 1-hour exposure.

The absolute mean OD570

(optical density at 570 nm) of the negative control tissues was

within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance

limit 2.8) and the laboratory historical control data range.  In the range of 20 - 100%

viability the Coefficient of Variation between tissue replicates was  16% for the negative

control, indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test item.  The

relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item

compared to the negative control tissues was 77% and 6.4%, respectively.  Because the mean

relative tissue viability for the test item was below 15% after the 1-hour treatment it is

considered to be corrosive.  

In conclusion, 1,3-dichloro-2-propanol is corrosive in the in vitro skin corrosion test under the

experimental conditions described in this report.