(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Cas Number:

2233585-18-5

Molecular formula:

C39H46N2O12

IUPAC Name:

(2E,2'E)-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2-methylpropane-2,1-diyl) bis(2-cyano-3-(3,4-dimethoxyphenyl)acrylate)

Test material form:

solid

Remarks:

Light yellow solid (powder)

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: not specified

Source strain:

not specified

Details on animal used as source of test system:

Test System Identification
A unique number was assigned to each tissue. Plates were labeled appropriately with at least the PSL study number, tissue numbers, and PSL ID or control type ((i.e., Negative Control (NC) or Positive Control (PC)).

Test System Requirements
4.B.1 Number of EpiDerm™ tissues: 9
4.B.2 Number of Groups: 3
Test Groups: 1
Negative Control Group: 1
Positive Control Group: 1
4.B.3 Number of Tissues per Group: 3
4.B.4 Source: MatTek Corporation, 200 Homer Ave., Ashland, MA 01721. The EpiDerm™ tissues (surface 0.63 cm²) were cultured on specially prepared cell culture inserts and shipped as kits, containing up to 24 tissues on shipping agarose.

Justification for test system used:

The test system (non-transformed human-derived epidermal keratinocytes cultured to form a complex model of the human epidermis) was validated and approved by regulatory authorities for evaluation of skin irritation potential. The EpiDerm™ SIT was developed and designed to predict skin irritation potential of neat test substances in the context of identification and classification of skin irritation hazard according to the EU classification system (R 38 or no label). The procedure described also allows for hazard identification of irritant substances in accordance with UN GHS and for discrimination between irritants that fall within category 2 and non-irritants. The test does not discriminate between non-mandatory subcategories of the UN GHS, i.e., it does not distinguish between GHS Category 2 and Category 3 irritants.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg

Duration of treatment / exposure:

35min

Duration of post-treatment incubation (if applicable):

17h

Number of replicates:

24-well plate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean

Value:

ca. 98.6

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The results of the study met the requirements for a valid assay:
1) The standard deviation (SD) calculated from individual % tissue viabilities of the 3 identically treated replicates was ≤ 18%.
2) The mean viability of PC tissues expressed as % of the negative control tissues is ≤ 20%.
3) The mean OD570 of the NC tissues is ≥ 1.0 and ≤ 2.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, Chiguard GA403 is considered a non-irritant. Based on the results of this study, Chiguard GA403 meets the requirement for UN GHS Category: No Category.