Diallyl carbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-11-14 to 2002-02-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP-compliant screening study according to (not specified) OECD test guidelines principles and procedures of the GLP-regulations 1999/11/EC and Italian Decreto Legislativo 27 Gennaio 1992 n. 120

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

screening method

Deviations:

yes

Principles of method if other than guideline:

The number of animals was selected from availabe stock and allocated to treatment. Food was removed overnight prior to dosing. The next day (day 1) the required amount of test item was adminstered by gavage at a dose volume of 10 ml/kg using a rubber catheder attached to a syringe of suitable capacity. Food was made available approximately 4 hours after dosing. Animals were observed for clinical signs immediately upon dosing, approximately 1, 2 and 4 hours after dosing and daily thereafter.
Animals were weight on allocation to the study, prior dosing (day 1). They were subjected to gross necropsy examination for both external and internal abnormalities.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diallyl carbonate

EC Number:

239-106-9

EC Name:

Diallyl carbonate

Cas Number:

15022-08-9

Molecular formula:

C7H10O3

IUPAC Name:

bis(prop-2-en-1-yl) carbonate

Details on test material:

- Name of test material (as cited in study report): DAC
- Physical state: colourless liquid
- Lot/batch No.: 011009
- Expiration date of the lot/batch: October 9, 2002
- Storage condition of test material: ambient conditions
- Other: RTC reference number 5979

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

Dose 1: 500 mg/kg bw (3 males)
Dose 2: 200 mg/kg bw (3 females)
Dose 3: 25 mg/kg bw (3 females)

No. of animals per sex per dose:

Dose 1: 3 males
Dose 2: 3 females
Dose 3: 3 females

Control animals:

no

Results and discussion

Any other information on results incl. tables

Dose (mg/kg)	Sex	Clinical signs	Mortality	Necropsy
500	Male	No clinical signs noted. All animals died on day 2.	3/3	No abnormalities found.
200	Female	Hunched posture, piloerection, semi-closed eyes, reduced activity and green staining in the litter tray noted. One animal found dead on day 3. Recovery in surviving animals by day 7.	1/3	Abnormal red fluid in the stomach of early decent animal and generalised yellow staining of the skin. Single, pale area (9x4 mm) on the left kidney noted in 1 of the 2 surviving animals.
25	Female	No clinical signs noted during the observation period.	0/3	Abnormal clear/yellow oil in the stomach and in the jejunum, yellow/red mucoid material in all 3 animals.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained indicate the median lethal dose (LD50) to be in the region, or slightly in excess, of 200 mg/kg body weight.