Dihydro-3-(tetrapropenyl)furan-2,5-dione

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:

other: guideline study by 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Remarks:

Preceeds GLP guidance, but QA signature is available.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dihydro-3-(tetrapropenyl)furan-2,5-dione

EC Number:

247-781-6

EC Name:

Dihydro-3-(tetrapropenyl)furan-2,5-dione

Cas Number:

26544-38-7

Molecular formula:

C16H26O3

IUPAC Name:

3-dodecenyl dihydrofuran-2,5-dione

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: weighing between 200 and 300 gm
- Fasting period before study: The rats were deprived of food but not water for 24 hours prior to dosing.

- Housing:
- Diet : ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

1.0 gm/kg
2.0 gm/kg
4.0 gm/kg
8.0 gm/kg
16.0 gm/kg

No. of animals per sex per dose:

Five groups of 5 males

Control animals:

no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2.9 other: g/kg

Based on:

test mat.

95% CL:

> 2 - < 4

Mortality:

Group (g/kg) Motality
1.0 0/5
2.0 0/5
4.0 5/5
8.0 5/5
16.0 5/5

Clinical signs:

other: No untoward symptoms were observed at 1.0 gm/kg. At 2.0 gm/kg the animals were lethargic and oily looking for up to 48 hours. At 4.0 gm/kg the animals were severely depressed after 4 hours and semi-comatose within 12 hours. Death occurred within 72 hour

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Any other information on results incl. tables

Test Results

Dose Level (g/kg)	# of animals dosed	Motalities														Total dead 14 days	Total survived 14 days	Initial weight (g)	Final weight (g)
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
1	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	215	250
2	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	5	235	255
4	5	0	2	3											5	5	0	240
8	5	4													5	5	0	240
16	5	5													5	5	0	200

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Tetrapropenyl succinic anhydride (TPSA) was tested in rats for acute oral toxicity according to an OECD 423 protocol. THe LD50 was 2.9 g/kg bw or 2900 mg/kg bw. The substance is not classified according to Regulation EC No. 1272/2008.

Executive summary:

In an acute oral toxicity study, 5 groups fasted Sherman-Wistar strain Albino rats (five male/group) were given a single oral dose of test material at a dose level of  1.0, 2.0, 4.0, 8.0 and 16.0  g/kg bw and observed for14 days.

No untoward symptoms were observed at 1.0 gm/kg. At 2.0 gm/kg the animals were lethargic and oily looking for up to 48 hours. At 4.0 gm/kg the animals were severely depressed after 4 hours and semi-comatose within 12 hours. Death occurred within 72 hours. At 8.0 gm/kg and 16.0 gm/kg the animals were semi-comatose after 4 hours and subsequently died within 12-48 hours. All survived animals showed expected bodyweight gain during the study period.

The oral LD50 value of test material in male Sherman-Wistar rats has been determined to be 2.9 g/kg bodyweight, with 95% confidence intervals of 2.0-4.0 g/kg bodyweight.