Fatty acids, C9, hexaesters with dipentaerythritol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7/8/02

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

EC Number:

267-021-7

EC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Cas Number:

67762-52-1

Molecular formula:

Not defined because UVCB

IUPAC Name:

Fatty acids, C5-9, hexaesters with dipentaerythritol

Test material form:

liquid: viscous

Details on test material:

Pale yellow liquid
Used as received

In vitro test system

Test system:

human skin model

Remarks:

Reconstructed Human Epidermis (RHE)

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

test material used as received, undiluted

Duration of treatment / exposure:

1, 4, and 24 h

Number of replicates:

each treatment was conducted in duplicate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

ET50 (hr) > 24

Value:

88.4

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions.

Executive summary:

A study was conducted to evaluate the skin irritation potential of the test substance according to a method similar to OECD Guideline 439. MatTek EpiDerm tissue samples were exposed to undiluted substance for 1, 4 or 24 h. Following treatment, the viability of the tissues was determined using MTT uptake and conversion, and the absorbance of each sample was measured at 450 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of the control values. The mean percent viability for each time point was used to calculate an ET50 which represents the time at which the EpiDerm tissue viability was reduced by 50% compared to the control tissues. The substance produced an ET50 > 24 h, indicating that it was non-irritating under the study conditions (DeGeorge, 2002).