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Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: relevance limited, limited report focussing on benzyl alcohol toxicity

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance (15%, v/v) was prepared in peanut oil and administered intraperitoneally at doses from 500 to 1500 mg/kg and observed. Animals that survived the observation period of 4 h were monitored daily for lethal effects for up to two weeks. Duplicate experiments were carried out on consecutive days and cumulative data were used in determining the LD50’s.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzaldehyde
EC Number:
202-860-4
EC Name:
Benzaldehyde
Cas Number:
100-52-7
Molecular formula:
C7H6O
IUPAC Name:
benzaldehyde
Details on test material:
No data given

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: adults
- Weight at study initiation: 23-28 g
- Housing: Five mice were housed per individual cage.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

No additional data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
peanut oil
Details on exposure:
The test substance (15%, v/v) was prepared in peanut oil. Compounds were administered intraperitoneally at concentrations which did not produce observable signs of peritoneal irritation. The volume administered did not exceed 0.1 mL per 10 g of body weight. Mice receiving a comparable volume of isotonic saline, peanut oil, or dimethyl sulfoxide served as control animals. Precautions were taken to insure minimal distress to the animals such as using peanut oil as the drug vehicle and anesthesia for all surgical procedures.
On the day of testing, the test compound was administered to four mice at the dose level of 500 mg/kg. Each animal was observed for the following signs: tremors, piloerection, change in motor activity, ataxia, dyspnea, and seizures.
Taking into account the lack of mortality among animals receiving 500 mg/kg of the test substance, additional groups were injected with the test substance at doses from 500 to 1500 mg/kg and observed. Animals that survived the observation period of 4 h were monitored daily for lethal effects for up to two weeks. Duplicate experiments were carried out on consecutive days and cumulative data were used in determining the LD50’s.
Doses:
500-1500 mg/kg
No. of animals per sex per dose:
four males per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: monitored daily
- Other examinations performed: clinical signs, body weight

No additional data
Statistics:
Statistical evaluation of dose effect experiments was done using the chi square method of analysis as described by Litchfield and Wilcoxon. Statistical significance of plasma levels was determined using the t test.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 150 mg/L
Based on:
test mat.
Remarks on result:
other: 4 h
Mortality:
No additional deaths were seen over the 7-d period during which the animals were observed.
Clinical signs:
The most prominent signs of toxicity to the test substance were tremors, sedation, respiratory distress, and, in animals monitored over a 7-day period. Dyspnea was most distinct 15 to 30 min after treatment, and coincided with the highest concentration of the test substance found in the plasma of animal receiving 1150 mg/kg the test substance.
Body weight:
There was a loss of body weight averaging 2.25 g per animal.
Gross pathology:
No additional data
Other findings:
No additional data

Applicant's summary and conclusion

Conclusions:
The LD50 (4 h) for the test substance in adult mice was found to be 1150 mg/kg.
Executive summary:

The test substance (15%, v/v) was prepared in peanut oil and administered intraperitoneally at doses from 500 to 1500 mg/kg and observed. Animals that survived the observation period of 4 h were monitored daily for lethal effects for up to two weeks. Duplicate experiments were carried out on consecutive days and cumulative data were used in determining the LD50’s.

The LD50 (4 h) for the test substance in adult mice was found to be 1150 mg/kg.