Alcohols, C14-18 and C16-18-unsatd.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Nov 2014 - 20 Nov 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD and EC guidelines and in compliance with GLPStudy conducted to OECD and EC guidelines and in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Unjecol 84AN
- Physical state: Liquid
- Analytical purity: 98%
- Lot/batch No.: 5253
- Expiration date of the lot/batch: 30 October 2015
- Storage condition of test material: Room Temperature

Test animals

Species:

other: not applicable, in vitro test, human epidermis model

Strain:

other: Not applicable.

Details on test animals or test system and environmental conditions:

-Not applicable, as an human epideris model was used.
On receipt, the kit contents were checked and the inserts with tissues on agarose were stored at room temperature until use. The kit was used within the expiry date indicated by the supplier (expiry date: 22 December 2014). The maintenance medium was pre-warmed to 37ºC. The tissues were removed from the agar and placed into wells of 12 well plates containing 2 mL pre-warmed maintenance medium per well. The tissues were incubated for a minimum of 24 hours at 37 ± 2 ºC in a humidified atmosphere of 5% CO2 in air.

Test system

Type of coverage:

other: Not applicable for In-Vitro tests

Preparation of test site:

other: Not applicable for In-Vitro tests

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

10 μL neat test substance

Duration of treatment / exposure:

24 hr incubation in maintenance medium, doses for 15 min with test substance, negative/positive controls at RT, then rinsing, followed by 42 h of post-incubation period at 37 °C, transfered to wells containing 2mL 0.3 mg/mL MTT, incubated for 3 hours

Observation period:

cell viability measurement: 3 h

Number of animals:

N/A - In-Vitro assay

Details on study design:

The test substance was applied to EpiSkin™ human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The constructs were treated with the neat test substance for 15 minutes. After rinsing of the test substance the constructs were incubated for 42 hours. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared tonegative control viability) to identify irritant and non-irritant substances.

This assay was valid with negative and positive controls showing results within the acceptable
range.

Controls
The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% Sodium Dodecyl Sulphate (SDS) in purified water.
Preparation/application of samples

The test substance, Unjecol 85AN, positive and negative controls were in liquid form and were applied by dispensing a volume of 10 µL over each tissue using a positive displacement pipette.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Value:

132.5

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Value:

120.2

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation / corrosion parameter:

% tissue viability

Value:

109.2

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

In vivo

Irritant / corrosive response data:

The test substance elicited a mean tissue viability of 120.6 ± 11.6% and was predicted as non-irritant to the skin.

Any other information on results incl. tables

Results from assay

Sample	Tissue viability as percentage of mean OD negative control				Prediction MTT endpoint
	Replicate Tissues			Mean ± SD
	a	b	c
Negative Control	88.6	95.4	116.1	100.0 ± 14.3	Not applicable
Positive Control	16.0	14.0	14.3	14.7 ± 1.1	Irritant
Unjecol 85AN	132.5	120.2	109.2	120.6 ± 11.6	Non-Irritant

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

It was concluded that the test substance, Unjecol 85AN, with a mean tissue viability of 120.6 ± 11.6%, was predicted as non-irritant to the skin.