4,4-dimethyloxazolidine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Two New Zealand albino rabbits (all male) were treated at each dose level (200 mg/kg, 970 mg/kg, 2000 mg/kg)
The skin of one rabbit from each pair was abraded by light scoring with a scalpel blade. The entire trunk of the rabbit was wrapped with a tight-fitting sleeve constructed of rubber dam material backed by aluminum screening. after 24 hs exposure, test areas were wiped clean with paper towels which were soaked in tepid tap waterAfter 24-hour exposure period, the skin responses were evaluated and the animals were returned to cages and held for a 14 days observation period.
- Necropsy of survivors was performed
- Other examinations performed: clinical signs, body weight

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,4-dimethyloxazolidine

EC Number:

257-048-2

EC Name:

4,4-dimethyloxazolidine

Cas Number:

51200-87-4

Molecular formula:

C5H11NO

IUPAC Name:

4,4-dimethyl-1,3-oxazolidine

Test material form:

liquid

Specific details on test material used for the study:

- Test material name: Oxazolidine-A
- Lot No. of test material: 575916
- Purity: 87.4%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: not specified; adults
- Weight at study initiation: 2-3 kg
- Housing: Cages, not further specified

ENVIRONMENTAL CONDITIONS
- not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: skin of the lateral trunk of rabbits from which the hair had been removed by clipping. The skin of one rabbit from each pair was abrader by light scoring with an scalpel blade
- Type of wrap if used: the entire trunk of the rabbit was wrapped with a tight-fitting sleeve constructed of rubber dam material backed by aluminum screening.

REMOVAL OF TEST SUBSTANCE
- Washing: Test areas were wiped clean with paper towels which were soaked in tepid tap water
- Time after start of exposure: 24-hour exposure period

TEST MATERIAL
- Amount(s) applied : animal #1and 2 0.57 ml, animal #3: 2.85 ml, animal #4: 3.24 ml, animal #5: 6.27ml and animal#6: 5.63 ml
- Concentration: undiluted
- Constant volume or concentration used: no, volume was changed according to animal weight

Duration of exposure:

24 hours

Doses:

200 mg/kg, 970 mg/kg, 2000 mg/kg

No. of animals per sex per dose:

Two rabbits (all male) were treated at each dose level.
The skin of one rabbit from each pair was abraded by light scoring with a scalpel blade.

Control animals:

no

Details on study design:

- Duration of observation period following administration: After 24-hour exposure period, the skin responses were evaluated and the animals were returned to cages and held for a 14 days observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 970 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The two animals exposed to 2000 mg/kg died during the 24-hour exposure period.

Clinical signs:

other: There was continued and progressive severity of the skin responses during the 2-week observation period. At the time of necropsy, the test areas were covered by thick eschar formation; there was serous or puriform exudate under the eschar. This latter eff

Gross pathology:

Aside from the obvious effects on the skin, there were no remarkable findings at necropsy.

Other findings:

There were no detectable changes in behaviour

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Remarks:

estimated LD50 on this experiment 970-2000 mg/kg.

Conclusions:

Treatment of rabbits by dermal application of Oxazolidine-A (CAS 51200-87-4) resulted in severe skin responses as determined by erythema or eschar formation and the production of edema. At the highest dose tested, 2000 mg/kg, a systemic effect was produced as was evidenced by the death of both test animals within 24 hours after application of the test material. The estimated LD50 on this experiment was 970-2000 mg/kg.

Executive summary:

Two New Zealand albino rabbits (all male) were treated at each dose level (200 mg/kg, 970 mg/kg, 2000 mg/kg)

The skin of one rabbit from each pair was abraded by light scoring with a scalpel blade. The entire trunk of the rabbit was wrapped with a tight-fitting sleeve constructed of rubber dam material backed by aluminum screening. after 24 hs exposure, test areas were wiped clean with paper towels which were soaked in tepid tap waterAfter 24-hour exposure period, the skin responses were evaluated and the animals were returned to cages and held for a 14 days observation period.

Necropsy of survivors was performed. Other examinations performed: clinical signs, body weight

Treatment of rabbits by dermal application of Oxazolidine-A (CAS 51200-87-4) resulted in severe skin responses as determined by erythema or eschar formation and the production of edema. At the highest dose tested, 2000 mg/kg, a systemic effect was produced as was evidenced by the death of both test animals within 24 hours after application of the test material. The estimated LD50 on this experiment was 970-2000 mg/kg.