Benzoin Sumatra resinoid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Pre-GLP study with following restrictions: observation period was 7 days only; rationale for dose selection was not provided (highest tested dose was 10000 mg/kg bw); body weight and necropsy examinations were not performed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Observation period of 7 days only

Deviations:

not applicable

Principles of method if other than guideline:

In an acute oral toxicity study, a single dose of 2500, 5000 or 10000 mg/kg bw of the test substance suspended in 40% ethanol was given to groups of male rats (6/dose). Observations for toxic symptoms and mortality were made for 7 days, and the survivors were sacrificed without autopsy.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resinoid of Styrax benzoin (Styracaceae) obtained from exudate by ethanol extraction

EC Number:

946-569-7

IUPAC Name:

Resinoid of Styrax benzoin (Styracaceae) obtained from exudate by ethanol extraction

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Label of test material: Compound HKS (Benzoin)
- Date of receipt: 07 January 1970

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-250 g
- Fasting period before study: 16 hours prior to dosing

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

ethanol

Details on oral exposure:

None

Doses:

2500, 5000 and 10000 mg/kg bw suspended in 40% ethanol

No. of animals per sex per dose:

6 males per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Observations for toxic symptoms and mortality were made for 7 days. Cumulative mortality was recorded immediately after dosing and at 1 and 4 hours, and then once daily for 7 days.
- Necropsy of survivors performed: No

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

In 10000 mg/kg bw group, 2 animals died within a day. No animal died in other groups.

Clinical signs:

No principal toxic effect was noted.

Body weight:

Not applicable

Gross pathology:

Not applicable

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 of the test substance is considered as >5000 mg/kg bw in rats.

Executive summary:

In an acute oral toxicity study, a single dose of 2500, 5000 or 10000 mg/kg bw of the test substance suspended in 40% ethanol was given to groups of male rats (6/dose). Observations for toxic symptoms and mortality were made for 7 days, and the survivors were sacrificed without autopsy.

In 10000 mg/kg bw group, 2 animals died within a day. No other toxic effect was noted at any dose level.

Rat Oral LD50 >5000 mg/kg bw

Under the test conditions, the oral LD50 of the test substance is considered as >5000 mg/kg bw in rats.