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Administrative data

Description of key information

In an acute oral toxicity study on rats, the Oral LD50 was found to be superior to 5000 mg/kg. (pre- GLP, Rel. K2)

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:
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
Qualifier:
equivalent or similar to
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
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
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150-250 g
- Fasting period before study: 16 hours prior to dosing
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
Preliminary study:
Not applicable
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

None

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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.

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw