Fatty acids, C16-18 and C18-unsatd., reaction products with glycidyl neodecanoate and 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

Guideline study under GLP

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

: Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Molecular formula:

not available for UVCB substances

IUPAC Name:

: Esterification reaction of fatty acids, C16-18 and C18-unsatd.; 3,4-epoxycyclohexyl methyl-3,4-epoxycyclohexan carboxylate and neodecanoic acid, oxiranylmethyl ester

Test material form:

liquid

Details on test material:

UVCB Purity 100% Batch number:210164480 Expiration Date: 16 December 2017

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Human derived transformed keratinocytes.

Cell source:

other: EpiDerm(R)

Details on animal used as source of test system:

Origin:
EpiDerm(TM) tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 08. Mar. 2016
Batch no.: 23320

Justification for test system used:

validated test system

Vehicle:

unchanged (no vehicle)

Details on test system:

Specification:
Commercially available EpiDerm (TM)-Kit.
The EpiDerm(TM) tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm(TM) tissues are cultured on specially prepared cell culture inserts.

Control samples:

yes, concurrent positive control

other: Dulbecco PBS

Amount/concentration applied:

The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2)

Duration of treatment / exposure:

60 minutes

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

main

Value:

>= 105.3 - <= 106.2

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

Results given as % of negative control

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: tested and found to be inactive
- Colour interference with MTT: tested and found to be inactive

DEMONSTRATION OF TECHNICAL PROFICIENCY:

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: within range

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Skin irritation of the test substance was tested in vitro using the EpiDerm (R) system in OECD 439 guideline under GLP. No decrease in cell viability was observed, as measured by MTT reduction to formazan. The substance is not classified as a skin irritant.