2-Propenenitrile, polymer with 1,2-ethanediamine

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: 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:

2018 study following guidelines and performed to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Water-free material
Purity: 92.5%
Physical state/Appearance: Greenish-yellow viscous liquid

Species:

cattle

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

0.75 ml undiluted added to the chamber with the cornea

Duration of treatment / exposure:

Incubated at 32 ± 1 ºC for 10 minutes

Duration of post- treatment incubation (in vitro):

120 minutes

Number of animals or in vitro replicates:

Three replicates for test material and controls

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

ca. 2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

The positive control In Vitro Irritancy Score was within the range of 31.6 to 58.7.

The negative control gave opacity of ≤3.0 and permeability ≤0.077.

Interpretation of results:

GHS criteria not met

Conclusions:

Although the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, the method is validated to accept very low scores as being non-classified for CLP.
The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.
The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

In the skin assay, the mean cell viability of 91.7% suggested that the material is of low irritancy and classification under CLP is not required.

For the eye study, it is noted that the study design is more suitable for the Eye Dam 1 and Eye Irrit 2 boundary, although the method is validated to accept very low scores as being non-classified for CLP.

The method was chosen as the substance was considered likely to be Eye Irrit 2 based on free amine and reported pH.

The irritation scroe of 2.0 is sufficiently low to conclude non-classification for CLP