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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
yes
Remarks:
Some housing conditions are not reported (temperature, humidity, air changes); lack of details on the test item; no (historical) control group
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by cyclohexane extraction
EC Number:
946-584-9
Molecular formula:
Not applicable (UVCB)
IUPAC Name:
Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by cyclohexane extraction
Test material form:
solid
Specific details on test material used for the study:
Name in the study report: Elemi resinoid (Canarium spp.)
Test article label: #1259-93
Date of reception: 13 July 1993
Storage: in refrigerator and protected from light
Description: yellow solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Females nulliparous and non-pregnant
- Weight at study initiation: 236-256 g for males; 237-250 g for females
- Fasting period before study: yes (16-20 hours before dosing)
- Housing: 5/sex/cage in suspended wire mesh cages
- Diet (e.g. ad libitum): Fresh Purina Rodent Chow (Diet #5012), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS

- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 July 1993 To: 03 August 1993

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was melted (heated) in to a liquid state and the dose was based on the sample weight as calculated from the specific gravity (1.01).
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed 1, 2 and 4 h post dose and once daily for 14 days. They were observed twice daily for mortality. Bodyweights were recorded before dosing, weekly and at termination.
All animals were examined for gross pathology.
Statistics:
The LD50 and 95% confidence limits were calculated, if possible, by the method of Litchfield and Wilcoxon (JPET 96:99, 1949) or Horn (Biometrics 12:311, 1956)

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the observation period.
Clinical signs:
Chromodacryorrhea was noted in one male on days 4 and 5. All other animals appeared normal throughout the study.
Body weight:
No effects on bodyweights.
Gross pathology:
All animals were normal.
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, the oral LD50 of the test substance is >2000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and potentially not classified according to GHS as no mortality and no adverse clinical signs were observed at 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed according to OECD guideline 401 and GLP, single oral dose of 2000 mg/kg bw of the undiluted test substance, melted (heated) into a liquid state, was administered to 5 male and 5 female Wistar rats. Animals were then observed for mortality twice daily and for clinical signs of toxicity 1, 2 and 4 h after dosing and then daily for 14 days. Bodyweights were recorded before dosing, weekly and at termination.

 

No mortality occured during the observation period. Chromodacryorrhea was noted in one male on days 4 and 5. All other animals appeared normal throughout the study. Bodyweight changes and necropsy were normal.

 

Under the test conditions, the oral LD50 of the test substance is >2000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 and potentially not classified according to GHS as no mortality and no adverse clinical signs were observed at 2000 mg/kg bw.

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