Resinoid of Boswellia Carterii (Burseraceae) obtained from exudate by hexane extraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Rats were given a single oral dose of test substance at 5000 mg/kg bw and then observed for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

None

IUPAC Name:

None

Test material form:

solid

Specific details on test material used for the study:

- Description: solid in chunk ranging from light yellow to light amber in color
- Date of receipt: 28 May 1971

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- bodyweights: 150-300 g
- individually housed
- Diet: commercial diet, ad libitum
- Water: Water, ad libitum
- Fasting period before study: Animals were fasted for 24 h prior to administration of the test item.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Test material was prepared as 50% (w/v or v/v) suspension in corn oil

Doses:

5 g/kg bw

No. of animals per sex per dose:

1 then 4 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for mortality and clinical signs 1 and 4 h after administration and daily for 14 days
- Necropsy of survivors performed: gross necropsy was performed on any animal that died during the study and on survivors which were killed by cervical dislocation at termination.
- Two rats were first dosed. As no death occurred, 8 additional animals were tested.

Statistics:

The LD50 value was walculated according to Horn's method.

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:

one autolyzed rat was found

Clinical signs:

No toxic signs were observed.

Body weight:

No data

Gross pathology:

No effect

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, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) N° 1272 -2008 and GHS.

Executive summary:

In an acute oral toxicity study (limit test), 2 Sprague Dawley rats (male/female) were given a single oral dose of olibanum gum diluted at 50% in corn oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs 1 and 4 h after administration then daily for 14 days. As no deaths occurred, 8 additional rats were given the same dose via the same route.

One autolyzed animal was found. No toxic signs were noted and no effect was recorded at necropsy. In this study, the oral LD50 of test substance was higher than 5000 mg/kg bw in rats.

 

Under the test conditions, oral LD50 of test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according the Regulation (EC) N° 1272 -2008 and GHS.