Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-10-17 to 2017-10-20

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 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:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

EC Number:

944-892-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Test material form:

liquid: viscous

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Human reconstucted epidermises

Cell source:

other: SkinEthic(TM)

Source strain:

not specified

Details on animal used as source of test system:

Human reconstructed epidermises SkinEthic(TM) RHE model (0.5 cm2), maintained according to the supplier's instructions.

Justification for test system used:

This study is carried out according to the OECD guideline 439 dated July 28th, 2015 and the epidermis supplier Standard Operating Protocol.

Vehicle:

unchanged (no vehicle)

Details on test system:

The certificate of analysis from the batch of epidermises with the viability, assessment of barrier function, the morphology and the determination of the absence of biological contamination is attached at the end of the report.
Irritation test was started at the epidermises receipt

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

16 µL +/- 0.5 µL of the test item or reference item were deposited with a positive displacement micropipette.

Duration of treatment / exposure:

The epidermises were incubated in 0.3 mL of maintenance medium (24 wells plate) at room temperature for 42 minutes +/- 1 minute.

Duration of post-treatment incubation (if applicable):

42 hours post-treatment incubation

Number of replicates:

Test item as well as the reference items were tested on three epidermises.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean viability

Value:

95.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Results table - ID-17/08642

		Assessment of viability							Conclusion
		(Abs. - blanc)			Mean Abs./Ep	Viability/Ep %	Standard deviation	Viability means %
Negative control	Ep. 1	1.357	1.430	1.421	1.402	106.0%	5.5%	100.0%	Non irritant
	Ep. 2	1.271	1.334	1.310	1.305	98.7%
	Ep. 3	1.233	1.288	1.261	1.260	95.3%
Positive control	Ep. 1	0.049	0.051	0.052	0.050	3.8%	0.5%	3.4%	Irritant
	Ep. 2	0.044	0.047	0.047	0.046	3.5%
	Ep. 3	0.037	0.039	0.039	0.038	2.9%
ID-17/08642	Ep. 1	1.401	1.411	1.393	1.401	106.0%	5.1%	100.9%	Non irritant
	Ep. 2	1.326	1.356	1.332	1.338	101.2%
	Ep. 3	1.278	1.245	1.274	1.265	95.7%
	T living NS	-	-	-	-	-	-	Corrected viability 95.1%
	MTT NS	0.077	0.081	0.073	0.077	5.8%	0.4%
	T death NS	-	-	-	-	-	-

Applicant's summary and conclusion

Interpretation of results:

other: not be classified

Conclusions:

Under the retained experimental conditions and according to the CLP regulation, the test item BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17-04-15001 code ID-17/08642 tested pure must not be classified. No symbol, risk phrase, no signal word or hazard statement is required.

Executive summary:

Title: In vitro skin irritation study of a test item on human reconstructed epidermis (SkinEthic model) according to the OECD guideline 439

Objective: The aim of the study id the evaluation of a test item capability to induce skin irritation effects by a cytotoxicity test on in vitro human reconstructed epidermises (SkinEthic(TM) RHE model).

After the test item application, pure, on epidermis for 42 minutes and 42 hours post-treatment incubation, cellular viability is evaluated by the measurement of the succinate deshydrogenase mitochondrial activity of the alive cells. This enzyme is involved in the transformation of MTT (3(4,5 -dimethylthiazol-2 -yl)-2,5 -diphenyltetrazolium bromide) into blue formazan cristal. A spectrophotometric measurement is performed after the crystal dissolution. The measured absorbances are proportional to the number of living cells.

This study is carried out according to the OECD guideline 439 dated July 28th, 2015 and the epidermis supplier Standard Operating Protocol.

Test item: BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17 -04 -15001

Test system: Human reconstructed epidermis SkinEthic(TM) RHE model (0.5 cm2) maintained according to the supplier's instructions.

Conclusion: Under the retained experimental conditions and according to the CLP regulation, the test item BUTYL AVOCADATE DISTILLE - REF : 8500013 - BATCH : 17-04-15001 code ID-17/08642 tested pure must not be classified. No symbol, risk phrase, no signal word or hazard statement is required.