2-Methoxy-6-methylbenzoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline study. Non-GLP. Test system only appropriate to address skin corrosion, but not irritaion effects.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Guideline:

other: EpiDerm (TM) Corrosivity-Test in vitro (OECD 431)

Principles of method if other than guideline:

Basic procedure of the EpiDerm (TM) Corrosion test:
From the day of arrival in the laboratory, tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application. Two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator, as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used. 25 μL highly de-ionized water was applied first. Thereafter, a bulk volume of 25 μL of the test material was applied with a sharp spoon and homogeneously distributed with the water. Control tissues were concurrently applied with 50 μL of highly de-ionized water (negative control, NC) or with 50 μL of 8 n potassium hydroxide (positive control, PC). A nylon mesh was placed carefully onto the tissue surface of the NC afterwards. The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation, tissues were washed with PBS and the formazan produced by the tissues was extracted with isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Methoxy-6-methylbenzoic acid

EC Number:

612-182-4

Cas Number:

6161-65-5

Molecular formula:

C9H10O3

IUPAC Name:

2-Methoxy-6-methylbenzoic acid

Details on test material:

- batch number: 30529/6
- substance number: 01/0246-1
- CAS number: 6161-65-5
- test substance name: BAS 560 F - (Benzoe-)Säure

Test animals

Species:

other: in vitro

Results and discussion

Any other information on results incl. tables

No direct MTT reduction observed.

	Exposure: 3 min
Test article	OD 570 tissue 1	OD 570 tissue 2	OD 570 KC	mean OD 570	mean OD 570 KC corrected	viability [% of NC]
NC	2.008	1.997	–	2.002	–	100
01/0246-1	1.988	2.041	–	2.014	–	101
PC_C	0.323	0.303	–	0.313	–	16
	Exposure: 1 h
Test article	OD 570 tissue 1	OD 570 tissue 2	OD 570 KC	mean OD 570	mean OD 570 KC corrected	viability [% of NC]
NC	1.887	1.955	–	1.921	–	100
01/0246-1	1.823	1.936	–	1.879	–	98
PC_C	0.113	0.17	–	0.141	–	7
NC = negative control
PC_C = positive control
OD 570 = optical density [wavelength 570 nm]
KC = killed tissue control (only included if applicable)

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Conclusions:

Based on the results of this study, a classification of the test substance for skin corrosion is not warranted. However, the design of this experiment does not allow the evaluation of skin irritation effekts.