Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 to 30 June 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Observation period: 7 days

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction.

Molecular formula:

Not applicable (UVCB)

IUPAC Name:

Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction.

Specific details on test material used for the study:

Extract of elemi gum with benzyl benzoate, containing 30% benzyl benzoate
Name of test material: Elemi resinoid P
Date of preparation: 10.9.84
Batch No: 651/84
Provider: PPF Bertrand Freres
Appearance: thick pale yellow jelly
Storage: ambiant temperature

Test animals

Species:

mouse

Strain:

not specified

Remarks:

white

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Age at study initiation: 4-5 weeks
- Weight at study initiation: Females: 17-23 g; males: 21-25 g
- Fasting period before study: 4 hours
- Housing: individually
- Diet (e.g. ad libitum): commercial pelleted diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

IN-LIFE DATES: From: 11 June 1985 To: 18 June 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: groundnut oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % w/v

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw

Doses:

2, 5 and 10 g/kg bw

No. of animals per sex per dose:

3 at 5 g/kg bw
1 at 2 and 10 g/kg bw

Control animals:

no

Details on study design:

The animals are observed for signs of toxicity for 7 days after intubation and any animal dying during this period is autopsied. Animals are weighed before administration and before killing at the end of the observation period. Post-mortem examination is then performed.

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

2/2 at 10 g/kg bw; 1/6 at 5 g/kg bw; 0/2 at 2 g/kg bw

Clinical signs:

All the mice dosed at 5 g/kg bw and 10 g/kg bw were shown signs of stress within 30 min after treatment. After 18 h, the mice dosed at 10 g/kg bw and one male dosed at 5 g/kg bw were also somnolent and showing laboured breathing. All these mice died within 22-25 h. All the surviving mice recovered within 18 h.

Body weight:

All the surviving mice gained weight during the 7-day observation.

Gross pathology:

Autopsy of the mice that died revealed:
- gaseous distension of the stomach and intestines
- pale liver
- diarrhoea
All the surviving mice presented a normal appearance at autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the LD50 of the test item is greater than 5000 mg/kg bw in mice therefore it does not require classification according to CLP and GHS criteria.

Executive summary:

3 groups of 4-5 week-old white mice were given a single dose of test item suspended in 20% w/v groundnut oil at 2, 5 and 10 g/kg bw. All the mice dosed at 5 g/kg bw and 10 g/kg bw were shown signs of stress within 30 min after treatment. After 18 h, the mice dosed at 10 g/kg bw and one male dosed at 5 g/kg bw were also somnolent and showing laboured breathing. All these mice died within 22-25 h. All the surviving mice recovered within 18 h.

Autopsy of the mice that died revealed:

- gaseous distension of the stomach and intestines

- pale liver

- diarrhoea

All the surviving mice presented a normal appearance at autopsy.

Under the test conditions, the LD50 of the test item is greater than 5000 mg/kg bw in mice therefore it does not require classification according to CLP and GHS criteria.