Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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:
- Lethargy, diarrhea and urinary incontinence
Body weight:
No data
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.