Bergamot, ext.

Acute Toxicity: oral

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

Test material information

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).