Methyl benzoylformate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl benzoylformate

EC Number:

239-263-3

EC Name:

Methyl benzoylformate

Cas Number:

15206-55-0

Molecular formula:

C9H8O3

IUPAC Name:

methyl oxo(phenyl)acetate

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 - 10 weeks, female animals approx. 12 - 14 weeks
- Weight at study initiation: 200-300g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and dorsolaterale parts of the trunk
- % coverage: 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with luke warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.75 ml/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: yes

For a better homogeneity the test item will be heated at 40°C for approx. 1 hour. The test item will be administrated hand warm.

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals will be observed individually for behaviour changes or signs of toxicity <0.5, 1, 2, 3, 4 and 5 hours after dosing at the day of administration and at least once daily thereafter. Clinical observations will be performed at least once each working-day and recorded individually. Individual body weight will be determined shortly before test item administration, at weekly intervals thereafter and before the sacrifice of the animals at the end of the observation period. Moreover, the body weights of animals that die or are sacrificed in a moribund state will be determined from study day 1, onward. A check for moribund and dead animals will be made at least once each workday.
- scoring: Individual recording of findings 30 - 60 minutes after removal of the semi- occlusive dressing; afterward, at approx. weekly intervals and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: On the last day of the observation period, the animals will be sacrificed by CO2-inhalation in a chamber with increasing concentrations over time, followed by necropsy and gross-pathological examination. All animals that die will be necropsied as early as possible after death.

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Other findings:

In all male animals well-defined erythema (grade 2) was noted on study day 1 and persisted in four of these animals until study day 3. Thereafter, very slight erythema (grade 1) was noted in these four animals from study day 6 until study day 7 or 8. In the fifth animal very slight erythema was seen from day 2 until day 8. Very slight edema (grade 1) was noted in all male animals on study day 1 only. Scaling was noted in three male animals from study day 7 or 8 until study day 10 after application.

In two females well-defined erythema (grade 2) was noted on study day 1, but decreased to very slight erythema (grade 1) in one of these animals and was noted from study day 2 until study day 7. In these two females very slight edema (grade 1) was seen on study day 1 after application only.
In the three remaining female animals very slight erythema (grade 1) was noted on study day 1, only.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material has an LD50 of >2000 mg/kg bw for acute dermal toxicity. This test value does not fulfill the criteria for classification and labelling according to EU regulation 1272/2008.

Executive summary:

In this guideline study (OECD 403) conducted with GLP certification, the acute dermal LD50 of the test material (EC 239-263-3) was determined to be >2000 mg/kg bw in the Rat. Test animals were exposed for 24 hours with a semiocclusive bandage. The test material was administered unchanged. The test material is not classified as acutely toxic according to the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008), based upon this result.