Ethylene carbonate

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study results summarized in inter-office correspondence. Insufficient experimental details provided to assess reliability.

Data source

Reference

Reference Type:

other: Inter-office correspondence

Title:

Unnamed

Year:

1953

Report date:

1953

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethylene carbonate

EC Number:

202-510-0

EC Name:

Ethylene carbonate

Cas Number:

96-49-1

Molecular formula:

C3H4O3

IUPAC Name:

1,3-dioxolan-2-one

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on exposure:

TEST SITE
- Area of exposure: closely clipped abdomen
- Type of wrap if used: rubber sheeeting and gauze wrapping

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Group 2: 1 ml/kg. Group 3: 4ml/kg
- Concentration (if solution): Group 2 and 3: 50% aqueous solution
- Constant volume or concentration used: no, Group 3 was changed from 4 ml/kg to 2 ml/kg of undiluted solution after the 5th application

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

5 days/week

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 other: mL/kg

Remarks:

basis: nominal per unit body weight

Doses / concentrations 2

Dose / conc.:

2 other: mL/kg

Remarks:

basis: nominal per unit body weight

Doses / concentrations 3

Dose / conc.:

4 other: mL/kg

Remarks:

basis: nominal per unit body weight

No. of animals per sex per dose:

6 animals/dose

Control animals:

yes

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily

DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Daily

OTHER: Animals were observed daily for systemic toxicity

Sacrifice and pathology:

- Gross and microscopic pathology evaluated at study completion

Results and discussion

Results of examinations

Clinical signs:

not specified

Dermal irritation:

no effects observed

Mortality:

not specified

Body weight and weight changes:

not examined

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

PATHOLOGY: Gross and microscopic pathology was minimal and renal damage was not found

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

No evidence of systemic toxicity was found.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, there was no significant skin reaction, no evidence of systemic toxicity, gross and microscopic findings were minimal and renal damage was not found after repeated dermal exposure of albino rabbits to the test substance.