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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
2-Propenenitrile, polymer with 1,2-ethanediamine
EC Number:
608-174-5
Cas Number:
28183-82-6
IUPAC Name:
2-Propenenitrile, polymer with 1,2-ethanediamine
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.