Bulnesia sarmienti, ext., sapond.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test was conducted according to methods similar to OECD guideline 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:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bulnesia sarmienti, ext.

EC Number:

289-632-8

EC Name:

Bulnesia sarmienti, ext.

Cas Number:

89958-10-1

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 canoot be given.

IUPAC Name:

Essential oil of Guaiacwood obtained from the wood of Bulnesia sarmientoi by steam distillation

Test material form:

not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology

Results and discussion

Preliminary study:

Not relevant

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

No effects observed

Body weight:

No data available

Gross pathology:

Necropsy performed: no effects

Other findings:

No other findings were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Guaiacwood oil in rats was established to be >5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified in accordance with 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of Guaiacwood Oil was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of Guaiacwood oil in rats was established to be >5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified in accordance with the classification criteria outlined in 1272/2008/EC (CLP).