2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

EC Number:

239-593-8

EC Name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

Cas Number:

15545-97-8

Molecular formula:

C16H28N4O2

IUPAC Name:

2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]

impurity 1

Reference substance name:

IUPAC-name not available, the reference substance may consist of one or more impurities

Molecular formula:

not applicable

IUPAC Name:

IUPAC-name not available, the reference substance may consist of one or more impurities

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

human

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

6 h at
37 ± 1 °C, 5 ± 1 % CO2 and 80 – 100 % relative humidity

Duration of post- treatment incubation (in vitro):

18 h at 37 ± 1 °C, 5 ± 1 % CO2 and 80 – 100 % relative humidity

Number of animals or in vitro replicates:

2 replicates

Results and discussion

In vitro

Results

Irritation parameter:

other: relative absorbance

Value:

111.4

Negative controls validity:

valid

Remarks:

optical density 1.5

Positive controls validity:

valid

Remarks:

relative absorbance 32.1 %

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test system, 2,2'-Azobis (4-methoxy-2,4-dimethylvaleronitrile) is considered as not eye irritant in the EpiOcularTM Eye Irritation Test.

Executive summary:

The test item 2,2'-Azobis (4-methoxy-2,4-dimethyl valeronitrile) was applied to a threedimensional human cornea tissue model in duplicate for an exposure time of 6 h. The solid test item was applied to each tissue. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution. Demineralised water was used as negative control, Methyl acetate was used as positive control. The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.5, OD was 1.5. The positive control showed clear eye irritating effects, the relative absorbance value was reduced to 32.1 % (< 50%). Variation within tissue replicates was acceptable (< 20%).

After treatment with the test item, the relative absorbance values were increased to 111.4 %. This value is well above the threshold for eye irritation potential (≤ 60%).