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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
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:
1975
Report date:
1975

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:
Cypress, Cupressus sempervirens, ext.
EC Number:
283-626-9
EC Name:
Cypress, Cupressus sempervirens, ext.
Cas Number:
84696-07-1
IUPAC Name:
Cypress, Cupressus sempervirens, ext.
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Cypress oil

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: 10 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observation: 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
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/10 animal was died on Day 1
Mortality:
1/10 animal was died on Day 1.
Clinical signs:
No clinical signs were observed.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.
Executive summary:

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

1/10 animal was died on Day 1. No clinical signs were observed. In this study, the oral LD50 of Cypress oil was higher than 5000 mg/kg bw in rats.

Under the test conditions, oral LD50 of Cypress oil is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008.

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