Propane-1,2-diyl diacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

3 April - 17 April 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to test guidelines and in accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,2-diyl diacetate

EC Number:

210-817-6

EC Name:

Propane-1,2-diyl diacetate

Cas Number:

623-84-7

Molecular formula:

C7H12O4

IUPAC Name:

propane-1,2-diyl diacetate

Details on test material:

Purity >99.5%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Ten young adult rats of the Wistar strain (approximately 6 weeks old) (SPF-quality, randomly bred) were obtained from Iffa-Credo, Brussels, Belgium. Date of arrival at the animal house: March 5, 1986. The quarantine period was 7 days. Another seven days prior to dosing the animals were individually housed in Macrolon cages (acclimation period). The body weights of the males on day 0 ranged from 326 to 360 g and those of the females from 216 to 251 g. The bedding material, purified sawdust (Woody Clean), was received from The Broekman Institute, Someren, The Netherlands. The animals had free access to tap-water and standard laboratory animal diet (RMH-B, pellet diameter 10 mm), which was obtained from Hope Farms, Woerden, The Netherlands. The animal room temperature was maintained at 19-21°C and the relative humidity at 40-70 per cent. The artificial light sequence was 12 hours light, 12 hours dark. Feed was withheld overnight before dosing till approximately 44-43 hours after administration of the test substance.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substance was dosed as such as a single dose using a stainless steel stomach cannula.

Doses:

5000 mg/kg (dose volume was 4.726 ml/kg body weight).

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

The test substance is administered orally by gavage in graduated doses to several groups of rats, one dose being used per group. Subsequently observations of toxic effects and deaths are recorded. Animals which die during the test and those killed at the end of the 14-day observation period are subjected to autopsy.

Statistics:

No additional information available.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the rats dosed with 5000 mg/kg died.

Clinical signs:

other: No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There was no evident sex related effect.

Gross pathology:

Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities.

Other findings:

No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 value for males and females combined was estimated to exceed 5000 mg/kg body weight. Hence, no classification according to EU criteria is required.

Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, received a single oral dose of DOWANOL PGDA at 5000 mg/kg body weight.

No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal. There was no evident sex related effect. Macroscopic examination of all animals at the end of the study revealed no test substance related gross.abnormalities.

Since no mortalities occurred, the LD50 value for males and femaIes combined was estimated to exceed 5000 mg/kg body weight.