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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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

Constituent 1
Chemical structure
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%).