2,2-dimethylpropane-1,3-diyl dibenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to the Guideline of today, but without gross pathology and without GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylpropane-1,3-diyl dibenzoate

EC Number:

224-081-9

EC Name:

2,2-dimethylpropane-1,3-diyl dibenzoate

Cas Number:

4196-89-8

Molecular formula:

C19H20O4

IUPAC Name:

3-(benzoyloxy)-2,2-dimethylpropyl benzoate

Specific details on test material used for the study:

- yellowish white chunks

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-244 g
- Fasting period before study: diet was withheld for up to 18 hours before doseing
- Housing: in groups of 5
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- temperature and humidity controlled quarters
- The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No.74-23 (N.I.H.) entitled "Guide for the care and use of laboratory animals"

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test material was administered orally by gavage as a suspension in corn oil. The dosage was administered at a volume of 20 ml/kg.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

5 males and 5 females were used in this study. The test material was administered orally by gavage as a suspension in corn oil. The dosage level was administered at a volume of 20 mg/kg. Observations for toxic signs were recorded during the first 4 hours following dosing, at 24 hours and daily thereafter for a total of 14 days. The rats were observed for mortality, clinical signs and body weight development.

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No rat died. All rats showed weight gain. Some rats developed hypoactivity, urine stained abdomen and diarrhea, but returned to normal within the 14 day observation period.

Mortality:

No rat died.

Clinical signs:

other: Some rats developed hypoactivity, urine stained abdomen and diarrhea, but returned to normal within the 14 day observation period.

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Five male and 5 female Sprague-Dawley rats received a single dose of 5000 mg/kg bw. The rats were observed for mortality, clinical signs and body weight development. No rat died. The discriminating dose is 5000 mg/kg bw.

Executive summary:

5 male and 5 female Sprague-Dawley rats were used to examine the acute oral toxicity in a study similar to the Guideline of today. There is no information on GLP and or gross pathology. 5000mg/kg bw of the test material was administered orally by gavage as a suspension in corn oil. The dosage level was administered at a volume of 20 ml/kg. Observations for pharmacotoxic signs were recorded during the first 4 hours following dosing, at 24 hours and daily thereafter for a total of 14 days. The rats were observed for mortality, clinical signs and body weight development. No rat died. All rats showed weight gain. Some rats developed hypoactivity, urine stained abdomen and diarrhea, but returned to normal within the 14 day observation period. Thus, the LD50 is > 5000 mg/kg bw.