Ferula galbaniflua, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard acute method

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,6-dimethyl-2-methylidenebicyclo[3.1.1]heptane

Cas Number:

93165-40-3

Molecular formula:

Not applicable (UVCB)

IUPAC Name:

6,6-dimethyl-2-methylidenebicyclo[3.1.1]heptane

Test material form:

liquid

Details on test material:

-Name Galbanum oil
-Batch no. 0715/1
-Appearance liquid, colorless to pale yellow
-Purity 100 % wt – UVCB substance
-CAS 8023-91-4
-EINECS 232-532-6
-Expiry date Jul. 2017
-Storage Room Temperature (20 ± 5°C)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed.
- Diet: Commercial diets, ad libitum
- Water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION:
Test substance was prepared as 50% (w/v or v/v) solutions or suspensions in corn oil.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Following the dosing, the toxic signs and mortality were recorded at one and four hours and once daily thereafter for a total of 14 days.
- Necropsy of survivors performed: Yes; gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.

Statistics:

LD50 was calculated according to Horn's method (Horn, 1956).

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain.

Gross pathology:

At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.

Executive summary:

In an acute oral toxicity study, group of 10 Sprague-Dawley rats were given a single oral dose of Galbanum at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and were all sacrificed for macroscopic examination.

 

No mortality was observed. Bloody crust nose, diarrhea, depression, lacrimation, face and body had brown stain. At termination, one animal had pale liver and kidneys; one animal showed hemorrhagic lungs. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, the oral LD50 for test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to Regulation (EC) No. 1272/2008 (CLP) and GHS.