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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

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:
Cardamom, ext.
EC Number:
288-922-1
EC Name:
Cardamom, ext.
Cas Number:
85940-32-5
Molecular formula:
Not applicable, UVCB
IUPAC Name:
1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 2-(4-methylcyclohex-3-en-1-yl)propan-2-yl acetate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cardamon oil
- Sample marking: EOA 72-89

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:
5000 mg/kg bw
No. of animals per sex per dose:
Total animals: 10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Mortality was observed in 5/10 animals at 5000 mg/kg bw.
Mortality:
- Mortality was observed in 5/10 animals at 5000 mg/kg bw (2 animals died on Day 1 and 3 animals died on Day 2).
Clinical signs:
other: - At 5000 mg/kg bw, lethargy, slow response and 6/10 animals showed negative righting reflex.
Gross pathology:
No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the oral LD50 for Cardamon oil is ca. 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).
Executive summary:

In an acute oral toxicity (limit test) study, a group of 10 rats were given a single oral dose of Cardamon oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

Mortality was observed in 5/10 animals at 5000 mg/kg bw (2 animals died on Day 1 and 3 animals died on Day 2). At 5000 mg/kg bw, lethargy, slow response and 6/10 animals showed negative righting reflex. In this study, the oral LD50 of test item was ca. 5000 mg/kg bw in rats.  

Under the test conditions, the oral LD50 for Cardamon oil is ca. 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008 (CLP).