Diphenyl carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diphenyl carbonate

EC Number:

203-005-8

EC Name:

Diphenyl carbonate

Cas Number:

102-09-0

Molecular formula:

C13H10O3

IUPAC Name:

diphenyl carbonate

Details on test material:

purity: 99.95 % Diphenyl Carbonate, 0.05 % phenol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, MA
- Age at study initiation: 32-68 days
- Weight at study initiation: 100-225 grams
- Fasting period before study: over night
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION (if unusual): Test substance was ground to a find powder and suspended in corn oil (heated to 45°C). The suspension was cooled to 37°C for dosing.

Doses:

750, 1500 and 3000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The method of Litchfield and Wilcoxon could not be employed due to a limitation in this procedure that requires at least two response values that are not 0 or 100 %.

Results and discussion

Preliminary study:

Limit study: 5/sex; dose: 5000 mg/kg bw; mortality: 7 of 10 animals died
Range Finding study: 1/sex/dose; doses: 500, 1000, 1500, 2000, 4000 mg/kg bw

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 500 mg/kg bw

Mortality:

3000 mg/kg: all animals died by the end of day 1
1500 mg/kg: two out of the ten animals (1m/1f) died by 4 h and 3 died (1m/2f) by day 1 of the study. Five animals survived the 14 day observation period
750 mg/kg: all animals survived at this dose level

Clinical signs:

other: 3000 mg/kg:  the one animal that survived until day 1 showed signs of clonic convulsions 1500 mg/kg:  the five surviving animals and three of the animals that died experienced clonic convulsions 750 mg/kg: none of the surviving animals exhibited any cli

Gross pathology:

no unusual lesions were noted in any of the animals

Applicant's summary and conclusion

Interpretation of results:

other: Acute category 4 according to EU criteria

Conclusions:

The LD50 of the test substance has been determined to be 1500 mg/kg bw based upon the observed 50 % mortality at this dose.

Executive summary:

The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guideline OECD 401, under GLP conditions.

During the study Sprague-Dawley male and female rats (five animals per sex per dose) were dosed with the test material in corn oil via gavage at 750, 1500 and 3000 mg/kw bw and observed over a 14 day period.

Under the conditions of this study, the acute oral LD50 of Diphenyl carbonate in rats was determined to be 1500 mg/kg bw, with clonic convulsions the main clinical sign appearing at doses near to or exceeding the LD50 value.