Mandarin orange, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are acceptable as basic data.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substance Act (FHSA)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mandarin oil

IUPAC Name:

Mandarin oil

Details on test material:

- Name of test material (as cited in study report): Mandarin italian oil
- Lot/batch No.: confidential

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: healthy male Wistar Albino rats
- Weight at study initiation: 20-250 g (in general)
- Fasting period before study: 16-20 hours
- Housing: 5 per cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Fresh Purina Rat Chow (Diet #5012) ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

no data

Doses:

single dose of 5000 mg/kg bw

No. of animals per sex per dose:

10 animals/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Frequency of observations and weighing: daily observations

Statistics:

The LD50 and 95% confidence intervals were calculated (if possible) by the method of Litchfield and Wilcoxon (1949) or Horn (1956).

Results and discussion

Preliminary study:

No animals died at an initial dose of 5.0 g/kg bw.

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0/10

Clinical signs:

other: no reactions observed

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Distribution of Mortality

Observation day	1	2	3	4	5	6	7	8	9	10	11	12	13	14
No. of Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in rats is > 5000 mg/kg bw under the conditions of this test. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008/EC and 67/548/EEC.

Executive summary:

In this acute oral toxicity study, a single dose of 5000 mg/kg bw Mandarin oil was given orally to 10 male Wistar rats. Animals were observed 3 -4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects. No deaths occurred, resulting in a LD50 > 5000 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 1272/2008/EC and 67/548/EEC.