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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Experimental conditions and detailed results are missing
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Essential oil of Canarium commune (Burseraceae) obtained from gum by steam distillation
EC Number:
945-898-3
Molecular formula:
not relevant for a UVCB substance
IUPAC Name:
Essential oil of Canarium commune (Burseraceae) obtained from gum by steam distillation
Test material form:
not specified
Specific details on test material used for the study:
None

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
None

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
None
Doses:
2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 370 mg/kg bw
Based on:
not specified
Remarks on result:
other:
Remarks:
±405 mg/kg bw
Mortality:
Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively.
Clinical signs:
Salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death
Body weight:
No data
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.
Executive summary:

In an acute oral toxicity study, single oral doses of 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw of the test substance were given to groups of rats (no. not specified). Animals were then observed for mortality and clinical signs of toxicity for 14 days.

 

Mortalities at 2000, 2500, 3000, 3500, 4000 and 5000 mg/kg bw were 0, 0, 1, 0, 2, 0 on Day 1; 0, 1, 3, 5, 5, 8 on Day 2; and 0, 0, 0, 0, 0, 0 on Days 3-14, respectively. Clinical signs included salivation, increased respiration, ataxia, exophthalmos, loss of righting reflex and depression until death.

 

Rat Oral LD50 = 3370±405 mg/kg bw.

 

Under the test conditions, the oral LD50 of the test substance is >2000 but <5000 mg/kg bw therefore it is not classified according to the Regulation (EC) N° 1272-2008 but classified as ‘Category 5, No symbol: Warning’ according to the GHS.