2-Oxazolidinone, 3-ethenyl-5-methyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-07-23 - 2014-08-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(adopted 30 May 2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

(adopted Aug 1998)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: - Japan MAFF Testing Guideline of 12 Nosan No. 8147 402.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-ethenyl-5-methyl-1,3-oxazolidin-2-one

EC Number:

809-852-5

Cas Number:

3395-98-0

Molecular formula:

C6H9NO2

IUPAC Name:

3-ethenyl-5-methyl-1,3-oxazolidin-2-one

Details on test material:

- Name of test material (as cited in study report): 5-Methyl-3-vinyloxazolidin-2-on
- Physical state: liquid /colorless to yellowish
- Analytical purity: 98.7 corr. area-%
- Test item No.: 14/0031-2
- Lot/batch No.: DEIMLIB 2014/2
- Expiration date of the lot/batch: Oct 01, 2014
- Homogeneity: The test item was homogeneouos by visual inspection
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: Room temperature

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 weeks, female animals approx. 12 weeks nulliparous and non-pregnant
- Weight at study initiation: males: 226-239 g, females:203-220 g
- Housing: single housing in Makrolon cage, type III
- Diet: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: about 40 cm² clipped skin of the dorsal and dorsolateral parts of the trunk
- % coverage: at least 10% of the body surface
- Type of wrap if used: The test item was covered with an air-permeable dressing

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.82 mL/ kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weight shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly therafter and on the last day of observation. Scoring was performed according to Draize.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred within the study period.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination within the study period. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of 5-Methyl-3-vinyloxazolidin after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of 5-Methyl-3-vinyloxazolidin-2-on (undiluted) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

Neither mortality, nor signs of systemic toxicity or skin effects were observed in the animals.

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

The mean body weight of the male animals increased within the normal range throughout the study period. In the female group three females marginally lost weight and another animal did not gain weight during the first week, but body weights were within the normal range during the second week. In the remaining fifth female the body weight increased within the normal range throughout the study period.

This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. Due to the fact that stagnation of body weight is commonly known for females dermally applied, this stagnation is considered to be unspecific.

No mortality occurred. Accordingly, the acute dermal median lethal dose (LD50) was determined to be

LD50, dermal, rat > 2000 mg/kg bw.