Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.