Dioctyl carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-05-05 to 1999-05-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24. February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test animals:
- Source: Harlan ltaly S.r.l., 33049 San Pietro al Natisone (UD), ltaly
- Age at study initiation: ca. 5 -6 weeks
- Weight at study initiation: 126 - 150 g
- Fasting period before study: over night prior to dosing and a period of approximately 4 hours after dosing
- Housing: Animals were housed in groups of up to 5 animals of the same sex in polycarbonate cages measuring 59 x 20 x 39 cm and equipped with a stainless steel mesh lid and floor.
- Diet: commercially available laboratory rodent diet (Altromin MT, A. Rieper S.p.A., Bolzano, Italy) ad libitum
- Water: drinking water
- Acclimation period: at least 6 days

Enviranmental conditions:
- Temperature: 20 - 24 °C
- Humidity: 45 - 65 %.
- Air changes: no data
- Photoperiod: 12 hours light and 12 hours dark each day

In-life dates: From 1999-05-05 to 1999-05-25

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

The test item was administered orally by gavage to rats fasted over night prior to dosing. After dosing diet was witheld for 4 more hours.
Five groups, each of 1 male and 1 female, were allocated to the preliminary screen. A single group of 5 males and 5 females were allocated to the Iimit test.
The dose volume administered was 10 mL/kg bw.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

1 dose group of 5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: Each rat was observed ca. 1, 2, 4 and 6 hours after dosing and thereafter daily for aperiod of 14 days
- Frequency of observations and weighing: observations: daily; weighing : on day 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Statistics:

NA

Results and discussion

Preliminary study:

A preliminary dose-ranging screen was carried out, in which groups of 1 male and 1 female were dosed at Ievels of 128, 320, 800, 2000 and 5000 mglkg. Dosing was followed by a 7 day observation period. No significant toxicity occurred and a Iimit test was performed, a single group of 5 male and 5 female animals being dosed at a Ievel of 5000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following dosing.

Clinical signs:

other: Piloerection was apparent in all 5 male animals from Day 2 of the study (24 hours after dosing. Recovery had occurred by Day 7. No other signs of reaction to treatment were noted during the course of the study.

Gross pathology:

No abnormalities were found on necropsy of animals on termination of the study.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information