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Description of key information

No mortality or signs of toxicity were observed up to 5000 mg/kg in mice by oral administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Some limitations in the reporting of the experimental design and results.
Justification for type of information:
An assessment of acute toxicity is required to fulfil REACH Annex VII information requirements. An acute oral toxicity study identified in the literature search (Klimisch 2) was considered sufficient to fulfil the endpoint.
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The acute toxicity was determined according to Lorke (1983) A new approach to practical acute toxicity testing. Archives of Toxicology 54 (4): 275-287.
- Short description of test conditions: The compound was dissolved in corn oil and administered orally to mice. In the first step, animals received doses of 10, 100 and 1000 mg/kg. In the second step, doses up to 5000 mg/kg were administered.
- Parameters analysed / observed: Mortality and signs of toxicity
GLP compliance:
not specified
Remarks:
Study was performed in a university research laboratory.
Test type:
fixed dose procedure
Limit test:
no
Specific details on test material used for the study:
- Source: β-Caryophyllene (97% purity) was obtained from Sigma Chemicals (St Louis, MO, USA)
Species:
mouse
Strain:
other: NIH
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 25 g
- Housing: Polypropylene cages
- Diet: Rodent Laboratory chow 5001, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 23°C
- Photoperiod (hrs dark / hrs light): 12 h dark-light schedule
Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Not reported
Doses:
First step: 10, 100 and 1000 mg/kg
Second step: doses up to 5000 mg/kg
No. of animals per sex per dose:
Not reported
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days in the first step, observation period for second step not reported
Statistics:
None reported for mortality.
Preliminary study:
No mortality or other signs of toxicity were observed 7 days post-administration at doses of 10, 100 and 1000 mg/kg.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was detected at any dose level up to 7-days post administration
Clinical signs:
other: No signs of toxicity were observed at doses up to 5000 mg/kg.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study considered reliable with restriction (Klimisch 2), the LD50 (cut-off) was determined to be ≥ 5,000 mg/kg bw. No mortality or clinical signs of toxicity were observed.
Executive summary:

The acute oral toxicity of beta-caryophyllene was determined in 6 -week old male mice (2009). In the first step, animals received doses of 10, 100 and 1000 mg/kg of the test item dissolved in corn oil. No mortality or signs of toxicity wer observed 7 days post-administration. In the second step, doses up to 5000 mg/kg were administered. No mortality or signs of toxicity were observed up to 5000 mg/kg. This study was considered to be reliable with restriction (Klimisch 2), despite minor limitations in reporting. Since the substance has an acute LD50 in excess of 5000 mg/kg by the oral route of administration, the substance is not classifiable for acute toxicity by this route of exposure.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
One key study is available, which is considered to be reliable with restrictions (Klimisch 2) as it was published in a peer-reviewed journal, however there are limitations in the reporting of the experimental design and results.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of beta-caryophyllene was determined in 6 -week old male mice (2009). In the first step, animals received doses of 10, 100 and 1000 mg/kg of the test item dissolved in corn oil. No mortality or signs of toxicity were observed 7 days post-administration. In the second step, doses up to 5000 mg/kg were administered. No mortality or signs of toxicity were observed up to 5000 mg/kg. This study was considered to be reliable with restriction (Klimisch 2), despite minor limitations in reporting.

Justification for classification or non-classification

One acute toxicity study is available and considered to be reliable with restrictions (Klimisch 2). As the acute oral study resulted in predicted LD50 levels in excess of the 5000 mg/kg limit dose, it was concluded that the test substance is not classified for acute toxicity according to the CLP Regulation (EC) No 1272/2008.

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