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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
(no data on starting date) 30-AUG 1976 (date of report)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on test substance composition.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: performed according to standard acute method
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Santal synthétique
- Analytical purity: not specified
See confidential details on test material for more information

Test animals

Species:
rat
Strain:
other: CD (COBS)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Source: Charles River, France
- Age at study initiation: no data
- Weight at study initiation: 180-230 g
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS:
- Temperature: no data
- Humidity: no data
- Air changes: no data
- Photoperiod: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE:
- no vehicle
- product administered as such

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
0, 0.5 and 10 mL/kg (corresponding to 0, 4500 and 9000 mg/kg b.w.)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> mortality and clinical signs: observation at least once daily up to the end of the 14-day observation period (day 15).
> body weights: Weighing animals daily to lethal doses
- Necropsy of survivors performed: yes (macroscopic examination of main thoracic and abdominal organs).
Statistics:
Statistical analysis for body weight gain according to Student's t test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 9 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 5 mL/kg and only one female died at 10 mL/kg (day 5) (10%).
Clinical signs:
No symptom was noted at 5 mL/kg. Sedation and dyspnea were observed at 10 mL/kg.
Body weight:
No effect observed, all surviving animals had gained weight.
Gross pathology:
Macroscopic examination of the main organs showed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item was found to be > 9000 mg/kg bw in male and female CD rats. According to the UN GHS and CLP criteria, the substance is not classified for the acute oral toxicity.
Executive summary:

CD rats (5 Males + 5 Females per dose) have been exposed by gavage at 0, 5 and 10 mL/kg of Rhodiantal IBCH (corresponding to 0, 4500 and 9000 mg/kg). Observation period: 15 days.

Results: No mortality was observed at 5 mL/kg and only one female died at 10 mL/kg (day 5) (10%). No symptom was noted at 5 mL/kg. Sedation and dyspnea were observed at 10 mL/kg.

Under the conditions of this study, the acute oral LD50 value of the test item was found to be > 10 mL/kg (corresponding to > 9000 mg/kg ) in male and female CD rats. According to the UN GHS and CLP criteria, the substance is not classified for the acute oral toxicity.

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