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Description of key information

Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, GLP, K, Rel. 2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Acute toxicity via Oral route:

Based on the available information, the registered substance is:

-not classified according to the Regulation (EC) No. 1272/2008 and GHS.

Acute toxicity via Dermal route:This information is not available

Acute toxicity via Inhalation:This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw ≥ C > 300 mg/kg bw). No classification is required.

Specific target organ toxicity: single exposure (Dermal):This information is not available

Specific target organ toxicity: single exposure (Inhalation):This information is not available.

Based on its composition and its physical state, the registered substance is not classified for aspiration hazard acording to CLP Regulation and GHS.

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