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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1. Feb 2016 - 12.Feb. 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
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
Version 439, 28. July 2015
Deviations:
no
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

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
Amount Test Item:
1: 25.0 mg
2: 25.4 mg
3. 24.5 mg
Duration of treatment / exposure:
Duration of treatment: 60 min
Duration of post-treatment incubation (if applicable):
Post incubation: 19h and 15 min
Number of replicates:
Two Replicates

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
4. Feb. 2016 - 12. Feb. 2016
Value:
117.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance 2 2'-Azobis (4-methoxy-2 4-dimethylvaleronitrile) is considered as not skin irritant in Human Skin Model Test
Executive summary:

Three tissues of the human skin model EpiDermTM were treated with 2,2'-Azobis (4- methoxy-2,4-dimethyl valeronitrile) for 60 min. The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by supplier). DPBS-buffer was used as negative control, 5 % SDS solution was used as positive control. After treatment with the negative control, the absorbance values were within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.6. The positive control showed clear irritating effects. Relative absorbance was reduced to 3.7% (required: < 20 %). Variation within tissues was acceptable (required: ≤ 18 %).

After the treatment with the test item, the relative absorbance values were increased to 117.3 %. This value is well above the threshold for irritation potential (50%).