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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
Pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Commiphora myrrha, ext.
EC Number:
284-510-0
EC Name:
Commiphora myrrha, ext.
Cas Number:
84929-26-0
Molecular formula:
Not relevant, UVCB substance
IUPAC Name:
Commiphora myrrha, ext.
Specific details on test material used for the study:
No data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
1050, 1640, 2050, 2560, 3200 and 5000 mg/kg bw/day
No. of animals per sex per dose:
10 animals/dose for the dose: 2050, 2560, 3200 and 5000 mg/kg bw/day
5 animals/dose for the dose: 1050, 1640 mg/kg bw/day
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 650 mg/kg bw
Mortality:
10 mortality on 10 animals observed at 5000 mg/kg bw
10 mortality on 10 animals observed at 3200 mg/kg bw
8 mortality on 10 animals observed at 2560 mg/kg bw
9 mortality on 10 animals observed at 2050 mg/kg bw
2 mortality on 5 animals observed at 1640 mg/kg bw
1 mortality on 5 animals observed at 1050 mg/kg bw
Clinical signs:
No effects at the dose: 150, 1640 and 2050 mg/kg bw/day.
Slight lethargy, anorexia and emaciation observed at all the higher doses.
Body weight:
No data
Gross pathology:
None
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the experimental conditions of this study, the test substance is classified Acute tox 4 (H302) according to Regulation (EC) No. 1272/2008 (CLP) and to GHS
Executive summary:

In an acute oral toxicity study (limit test), ten rats were given  2050, 2560, 3200 and 5000 mg/kg bw/day and 5 rats were given 1050 and 1640 mg/kg bw/day of Myrrh oil . Animals were observed for mortality and clinical signs for 14 days.

10 mortality on 10 animals observed at 5000 mg/kg bw

10 mortality on 10 animals observed at 3200 mg/kg bw

8 mortality on 10 animals observed at 2560 mg/kg bw

9 mortality on 10 animals observed at 2050 mg/kg bw

2 mortality on 5 animals observed at 1640 mg/kg bw

1 mortality on 5 animals observed at 1050 mg/kg bw

In this study, the oral LD50 is  1650 mg/kg bw in rats.

Under the experimental conditions of this study, the test substance is classified Acute tox 4 (H302) according to Regulation (EC) No. 1272/2008 (CLP) and to GHS