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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
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.
Body weight:
Dose Level (g/kg) Initial Weight (g) Final Weight (g)
1 215 250
2 235 255
4 240
8 240
16 200
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.