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
Justification for type of information:
Performed 2018 to GLP using guidelines current at the time

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Named in some reports as 2-propenenitrile, polymer with 1,2-ethanediamine
Dried material, described as viscous liquid, is used for some tests.
Specific details on test material used for the study:
Purity: 92.5% after removal of water
Physical state/Appearance: Greenish-yellow viscous liquid
Material needed warming to 50 C for ease of handling

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Details on test system:
EPISKIN™ Reconstructed Human Epidermis Model Kit
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 μL (26.3 μL/cm2) of the test item was applied to the epidermis surface without dilution
Duration of treatment / exposure:
15 minutes
Duration of post-treatment incubation (if applicable):
Rinsed tissues were incubated at 37 °C
Number of replicates:
Three

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
ca. 91.7
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The relative mean viability of the test item treated tissues was 91.7% after a 15 minute exposure period and 42 hour post-exposure incubation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean cell viability of 91.7% suggested that the material is of low irritancy and classification under CLP is not required.