Sandalwood, ext.

Endpoint summary

Description of key information

No mortalities or signs of toxicity have been observed in a limit test with sandalwood, ext. by oral application at a limit concentration of 5000 mg/kg body weight in rats. Studies following dermal or inhalation exposure are not available. However, in a review article, data on acute dermal toxicity were found indicating absence of dermal toxicity (LD50 > 5 g/kg), but the original study is not available for review.

Also, a study about acute inhalation toxicity is cited in a review article, but the results were cited as internal comunication, not available for review. Also, exposure concentrations of mice were low (50 - 180 mg/m3), but no mortality was seen and motility effects had been investigated, showing that mice and mice pre-treated with caffeine showed a reduced motility, as expected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

no

Remarks:

Test not conducted for regulatory purposes, published research paper.

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Albino Wistar rats of either sex weighing 150 - 200 g were housed under standard conditions at 25 ±5 ºC in a well-ventilated animal house approved by Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA Nº IAEC/37/10) under 12:12 h light - dark cycle. The experimental protocol (IAEC/NCP/37/10) was approved by Institutional Animal Ethical Committee, Nargund College of Pharmacy, Bangalore

Route of administration:

oral: drinking water

Vehicle:

water

Doses:

5000 mg/kg

No. of animals per sex per dose:

3 rats, sex not specified

Control animals:

no

Details on study design:

The S. album stem hydro-alcoholic Extract (SASE) at a limit dose of 5000 mg/kg was administered orally to three rats and observed for behavioural changes, any toxicity and mortality up to 48 h. The extract was prepared by dissolving the commercial extract in distilled water and the concentration was not to exceed the dose of 1 mL/100 g by weight.

Statistics:

not required

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

There were no mortalities in the limit test.

Clinical signs:

other: There were no signs of toxicity in the limit test.

Gross pathology:

no information about effects in the publication.

Interpretation of results:

GHS criteria not met

Conclusions:

No mortalities or signs of toxicity have been observed in the limit test at a limit concentration of 5000 mg/kg body weight in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

A supportive study showed no mortality, but the original study was not available - just the results were summarized in a review artcile.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

A supportive study showed no mortality (LD50 > 5 g/kg), but the original study was not available - just the results were summarized in a review artcile.

Justification for classification or non-classification

The substance was tested for acute oral toxicity at a limit dose of 5000 mg/kg bw and found being non-toxic. Thus, the substance is not subject to classification for acute oral toxicity or specific target organ toxicity upon single exposure according to GHS or CLP (Regulation EC No 1272/2008). Data for dermal and inhalation toxicity cannot be verified due to lack of access to the studies, but results cited ina review article do not show any mortality. Therefore, classification for dermal or inhalation toxicity (acute) is not required.