(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1972

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Test method and results not sufficiently detailed

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method according to the typical testing for acute oral toxicity: 10 animals/dose by oral gavage

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7,7-trimethylbicyclo[4.1.0]hept-3-ene

EC Number:

236-719-3

EC Name:

3,7,7-trimethylbicyclo[4.1.0]hept-3-ene

Cas Number:

13466-78-9

Molecular formula:

C10H16

IUPAC Name:

3,7,7-trimethylbicyclo[4.1.0]hept-3-ene

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period before study: 16 hours
- Diet: Ad libitum
- Water: Ad libitum

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

3200, 4200, 5000, 6250 and 7800 mg/kg bw

No. of animals per sex per dose:

10 male

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed at 1 and 6 hours after dosing and daily for 14 days
- Necropsy of survivors performed: yes

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 800 mg/kg bw

Based on:

test mat.

95% CL:

>= 4 000 - <= 5 600

Mortality:

- 2/10 at 3200 mg/kg bw; 5/10 at each of 4200 and 5000 mg/kg bw; 7/10 at 6250 mg/kg bw and 10/10 at 7800 mg/kg bw
- All deaths occurred at 6 hours to overnight following administration of drug

Clinical signs:

other: - Lethargy, diarrhea and urinary incontinence

Gross pathology:

No data

Other findings:

No data

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for delta-3-carene was found to be greater than 2000 mg/kg bw in the male albino Wistar rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.

Executive summary:

In an oral acute toxicity study five groups (10/dose) of male albino Wistar rats, received oral doses of delta-3-carene at 3200, 4200, 5000, 6250 and 7800 mg/kg bw. Animals were then observed for mortality and signs of toxicity for 14 days and were all macroscopically necropsied after sacrifice.

Following 6 hours to overnight of drug administration, 2, 5, 5, 7 and 10 deaths were observed at each tested dose level of 3200, 4200, 5000, 6250 and 7800 mg/kg bw, respectively. Animals experienced lethargy, diarrhea and urinary incontinence during the study. The oral LD50 was calculated to be 4800 mg/kg bw with 95% confidence limits of 4000 and 5600 mg/kg bw.

The oral LD50 for delta-3 -carene was found to be greater than 2000 mg/kg bw in the male albino Wistar rats and therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.