Fatty acids, vegetable-oil, polymd., unreacted fraction

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 November 2016 - 01 December 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, polymd., unreacted fraction

EC Number:

273-100-7

EC Name:

Fatty acids, vegetable-oil, polymd., unreacted fraction

Cas Number:

68937-92-8

Molecular formula:

Substance is a UVCB - no structural or molecular formula is available.

IUPAC Name:

5-[(5E)-icos-5-enoyloxy]icosanoic acid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RM1004951/1367Q13601
- Expiration date of the lot/batch: 15 May 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

As mandated in the guidelines.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 μL of the unchanged substance.

Duration of treatment / exposure:

3 minutes and 60 minutes.

Duration of post-treatment incubation (if applicable):

None.

Number of replicates:

Duplicate.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3-minute exposure

Value:

95

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60-minute exposure

Value:

96.1

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:

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

Any other information on results incl. tables

	Percentage Viability
Exposure Period	Negative Control	Positive Control	Test Item
3 Minute	100	3	95
60 Minute	100	2.9	96.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was considered to be non-corrosive to the skin.

Executive summary:

In an in vitro skin corrosion study human skin tissue (eipdermis keratinocytes) was exposed to the undiluted substance for 3-minutes and 1-hour. There was 95% and 96.1% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the test material is considered to be a non-irritant and non-corrosive to skin.