Tangor, Murcote, ext.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was conducted according to methods similar to OECD 401 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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)

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:

Tangor, Murcote, ext.

EC Number:

297-672-2

EC Name:

Tangor, Murcote, ext.

Cas Number:

93686-22-7

Molecular formula:

This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.

IUPAC Name:

(4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Sherman-Wistar (albino)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

no data available

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no
- Other examinations performed: symptomatology

Statistics:

no data

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

0/10

Clinical signs:

other: Diuresis, mild depressant effects noted one-half hour after dosing. Two females exhibited signs of morbidity; however, recovery was complete the following day.

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

Dosage level (g/kg)	No. Rats Dosed	day 1	day 2	day 3	day 4	day 5	day 6	day 7	day 8	day 9	day 10	day 11	day 12	day 13	day 14	Mortality after 14 days
5.0	5 males	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5
5.0	5 females	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/5

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Tangerine oil in rats was > 5000 g/kg bw under the conditions of this test.

Executive summary:

An acute oral toxicity study was performed by administering 5000 mg/kg bw of the test substance directly into the stomach of five male and five female albino rats. During a fourteen day observation period, no deaths occured. The LD50 of Tangerine oil is > 5000 mg/kg bw under the conditions of this test. Therefore, the test substance does not need to be classified accoring to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).