Schinus molle, 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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Pre-GLP study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Schinus molle, ext.

EC Number:

305-104-2

EC Name:

Schinus molle, ext.

Cas Number:

94334-31-3

Molecular formula:

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

IUPAC Name:

Schinus molle, ext.

Test material form:

liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

None

Applicant's summary and conclusion

Interpretation of results:

other: not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.

Executive summary:

Schinus Molle oil is tested for acute oral toxicity in a study performed similar to OECD TG 401. Ten rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. Daily observations were made for an period of 14 days. None of the animals died during the 14-day oberservation period. Furthermore, no subtance related clinical signs were observed. The LD50 was determined to be higher than 5000 mg/kg bw.