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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to methods similar to OECD guideline 401 and was performed pre-GLP. A concise description of the protocol is available and only mortality data are reported. Although concise, report is valid for acute toxicity assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Study was performed prior to implementation of OECD guideline 401. Methodology is comparable, though limited information on study protocol and test outcomes are available.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Bergamot oil - furocoumarin free quality
IUPAC Name:
Bergamot oil - furocoumarin free quality
Details on test material:
- Name of test material (as cited in study report): bergamot oil - furocoumarin free quality
- Physical state: clear liquid
- Analytical purity:100%

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150-250grams
- Fasting period before study: 18 hrs prior to dosing

ENVIRONMENTAL CONDITIONS
No further information provided

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
- Concentration in vehicle: 2500, 5000 and 10000 mg/kg bw
Doses:
1 dose at t=0
No. of animals per sex per dose:
6 male rats per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: no
- Other examinations performed: animals were examined for general toxic effects
Statistics:
No data provided.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
2 rats in the 10000 mg/kg bw dose group died within 1 day after administration.
Clinical signs:
other: No data provided.
Gross pathology:
No data provided.
Other findings:
Depression was observed. No further description provided.

Any other information on results incl. tables

Cumulative Mortality
Dose (mg/kg bw) Immediately 1 hrs. 4 hrs. 1 day 2 days 3 days 4 days 5 days 6 days 7 days
2500 0 0 0 0 0 0 0 0 0 0
5000 0 0 0 0 0 0 0 0 0 0
10000 0 0 0 2 2 2 2 2 2 2

Table 1. cumulative mortality of male albino rats after administration of bergamot oil by oral gavage.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of Bergamot oil in rats was established at exceeding 10000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).
Executive summary:

In an acute toxicity study, performed similar to OECD 401, male albino rats were exposed to bergamot oil (furocoumarin free quality). Rats were divided in 3 groups of 6 animals and were exposed via oral gavage to doses of resp. 2500, 5000 or 10000 mg/kg bw. Test animals were observed until 7 days after dosing. Within day 1 after dosing two rats in the 10000 mg/kg bw dose group died. No necropsies were performed. The oral LD50 value of Bergamot oil in rats was established at exceeding 10000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria as outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).