Methyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.02.1988 - 16.02.1988

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.3 (Acute Toxicity (Dermal))

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Remarks:

QAU statement is included

Test type:

standard acute method

Limit test:

yes

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:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht. Internal strain Hoe: WIDSKf (SPF71)
- Age at study initiation: male ca. 8 weeks, female ca. 9 weeks
- Weight at study initiation: male 201 g, female 196 g (mean values)
- Housing: Animals were held in fully conditioned rooms in single cages (Makrolon cages type 3) on soft wood granules
- Diet: Rattendiät Altromin ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ca. 30 cm² of the shaved dorsal skin
- Type of wrap if used: skin was covered with aluminium foil and in addition with an adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin ws washed with water
- Time after start of exposure: 24 hours after exposure


TEST MATERIAL
- Amount applied: 2000 mg/kg bw. Weight was calculated assuming a density of the test tem of 0.932 kg/l
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male plus 5 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed once per day, weighing was performed once per week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable (limit test)

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no clinical signs of toxicity were observed

Gross pathology:

no effects observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After an application period of 14 days followed by an observation period of 14 days, no mortality and other adverse effects were observed.

Executive summary:

The dermal toxicity of methyl acetate was assessed in a limit test. 2000 mg/kg bw of the test item was applied on the skin of Wistar-rats. The exposure period was 24 hours followed by an observation period of 14 days. No mortalities or other adverse effects were observed. It can therefore be concluded that the dermal LD50 is above the tested concentration of 2000 mg/kg bw.