2-cyclohexylethyl acetate

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

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

Test material

Test material information

Constituent 1

Reference substance name:

2-cyclohexylethyl acetate

EC Number:

244-543-3

EC Name:

2-cyclohexylethyl acetate

Cas Number:

21722-83-8

Molecular formula:

C10H18O2

IUPAC Name:

2-cyclohexylethyl acetate

Specific details on test material used for the study:

Designation in Test Facility: 17112908G
Date of Receipt: 29. Nov. 2017
Condition at Receipt Room temperature, in proper conditions
6.1.1 Specification
The following information concerning identity and composition of the test item was provid-ed by the sponsor.
Name Cyclohexyl ethyl acetate
Batch no. CP014-171101
Appearance colorless and transparent liquid
Composition Cyclohexyl ethyl acetate
Purity 99.85%
Homogeneity homogeneous
Expiry date 30. May 2019
Storage Room temperature (20 ± 5 °C)

The following additional information, also provided by the sponsor, was relevant to the conduct of the study, according to OECD 439:
CAS No. 21722-83-8
EINECS-No. 244-543-3
Stability in solvents unknown
Solubility unknown
Structural Formula /
SMILES Code not available

6.1.2 Storage
The test item was stored in the test facility in a closed vessel at room temperature (20 ± 5°C).

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: human-derived epidermal keratinocytes

Cell source:

other: a commercially available EpiDermTM-Kit, procured by MatTek.

Source strain:

not specified

Vehicle:

unchanged (no vehicle)

Details on test system:

Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM 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 representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.

Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Brati-slava.
Designation of the kit: EPI-200-SIT
Day of delivery: 15. May 2018
Batch no.: 28610

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30 µL test item

Duration of treatment / exposure:

1 hours and 35 minutes

Duration of post-treatment incubation (if applicable):

42 hours and 30 minutes

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 133.9

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Criterion Demanded Found
OD of negative control ≥ 0.8 and ≤ 2.8 1.3
% tissue viability
of positive control SDS ≤20% of negative control 2.9%
SD of mean viability of the
tissue replicates (%) ≤ 18% 11.1% (negative control)
0.4% (positive control)
4.5% (test item)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The mean value of relative tissue viability of the test item was increased to 133.9% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.