4'-methylacetophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2012-05-14 to 2012-08-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted under GLP in accordance with OECD TG 439.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 439

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4'-methylacetophenone

EC Number:

204-514-8

EC Name:

4'-methylacetophenone

Cas Number:

122-00-9

Molecular formula:

C9H10O

IUPAC Name:

1-(4-methylphenyl)ethanone

Test material form:

other: colorless to yellowish clear liquid

Details on test material:

- Name of test material (as cited in study report): Methyl acetophenone-para
- Physical state: colorless to yellowish clear liquid

Test animals

Details on test animals or test system and environmental conditions:

not relevant

Test system

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

15 min treatment + 42 h incubation

Number of animals:

not relevant

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, withPBS
- Time after start of exposure: 15 min

SCORING SYSTEM:
In vitro result: In vivo prediction:
mean tissue viability ≤ 50 % → irritant (I), H315 (category 2)
mean tissue viability > 50 % → non-irritant (NI)

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: Relative Absorbance

Value:

7.3

Remarks on result:

other:

Remarks:

Basis: other: Test item on EpiSkin. Max. score: 100.0. Reversibility: no data. Remarks: % of negative control. (migrated information)

Any other information on results incl. tables

Results after treatment with methyl acetophenone-para and controls

Dose group	Treat-ment interval	Absor-bance 540 nm Tissue 1*	Absor-bance 540 nm Tissue 2*	Absor-bance 540 nm Tissue 3*	Mean Absorbance of 3 Tissue	Relative absor-bance [%] Tissue 1, 2+3**	Stan-dard De-viation [%]	Rel. Absor-bance [% of negative control]***
Negative Control	15 min	1.154	1.047	1.032	1.077	107.1 97.2 95.8	6.2	100.0
Positive Control	15 min	0.175	0.142	0.154	0.157	16.3 13.2 14.3	1.6	14.6
Test Item	15 min	0.095	0.077	0.066	0.079	8.8 7.1 6.1	1.3	7.3

*Mean of two replicate after blank correction

**Relative absorbance per tissue [rounded values]: 100xabsorbance (tissue)/mean absorbance (negative control)

***Relative absorbance per treatment group [rounded values]: 100xmean absorbance (test item)/mean absorbance (negative control)

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It can be stated that in this study and under the experimental conditions reported, the test item METHYL ACETOPHENONE-PARA is irritant to skin according to UN GHS and EU CLP regulation.

Executive summary:

This in vitro study was performed to assess the irritation potential of METHYL ACETOPHENONE-PARA by means of the Human Skin Model Test according to OECD TG 439. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 μL of the liquid test item were applied to each tissue, spread to match the tissue size. 10 μL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD ≥ 0.6 till ≤ 1.5 for the 15 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 15 minutes treatment interval thus ensuring the validity of the test system. Compared to the value of the negative control, after exposure of the test item METHYL ACETOPHENONE-PARA the mean relative absorbance value decreased to 7.3%. This value is below the threshold for irritancy of ≤ 50%. Therefore, the test item is considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item METHYL ACETOPHENONE-PARA is irritant to skin according to UN GHS and EU CLP regulation.