Methyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.02.1988 - 05.02.1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Remarks:

QAU statement available

Test material

Test material information

Constituent 1

Reference substance name:

Methyl acetate

EC Number:

201-185-2

EC Name:

Methyl acetate

Cas Number:

79-20-9

Molecular formula:

C3H6O2

IUPAC Name:

methyl acetate

Details on test material:

- Name of test material (as cited in study report): Methylacetat
- Substance type: liquid
- Physical state: clear and colourless
- Analytical purity: 99.9% (w/w)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: in fully conditioned rooms in single cages (batteries)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum plus hay (ca. 15 g per day)
- Water: deionised and dechlorinised water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod: 12 hours dark / 12 hours light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

Exposure period: 4 hours

Observation period:

30 and 60 minutes, 24, 48 and 72 hours after tape removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 cm² of the shaved dorsal skin
- Type of wrap if used: exposed area was covered with a semiokklusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM:according to the guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.2

Reversibility:

fully reversible within: 48h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Other effects:

24, 48, and 72 hours after patch removal, dry skin was observed

Any other information on results incl. tables

Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 1	Max. score: 0
30-60 min	1/1/1	0/0/0
24 h	0/1/1	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.3/0.2	0/0/0
Reversibility*)	c	c
Average time (unit) for reversion	48 hours	48 hours

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, methyl acetate is not irritating to the skin and does not require labelling according to the dangerous substance directive.

Executive summary:

Methyl acetate was applied to the rabbit's skin. 0.5 ml of the test item was applied undiluted on the skin and covered with a patch for 4 hours. Effects were examined after 30 and 60 minutes, as well as after 24, 48 and 72 hours after patch removal. Only slight erytheme were observed after 30 -60 minutes as well as 24 hours after patch removal. Based on the results, methyl acetate can be considered as not irritant to skin and does not require labelling.

In-vitro testing for skin corrosion and skin irritation is not required.