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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Principles of method if other than guideline:
Acclimatization time at least 7 days
No food for 16 hours before oral administration
1 administration of the test substance by oral gavage
4 hours post application food is made available
Observation for 14 days
Clinical observations and necropsy after the 14 day period
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Test compound: PPC-H (P 0062/2/02)
Batch number 10339/2
White granules

Test animals

Species:
mouse
Strain:
NMRI
Remarks:
substrain: SPF (Han.)
Sex:
male/female
Details on test animals and environmental conditions:
- Strain: NMRI mice
- Colour: white
- Weight at study initiation: male: male: 28.8-38.4 g; female: 22.1-24.0 g
- Fasting period before study: 16 h
- Housing: Macrolon type III/max 5 mice per cage
- Diet: ad libitum 4 hours after administration
- Water: ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50-85 %
- Photoperiod (hrs dark / hrs light): 12 hrs light (7 am - 7 pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Animals were dosed once orally by stomac tubes
Doses:
Single dose
Range finding study:
Group 1: 6.5 g/kg
Group 2: 10.3 g/kg
Final study
Group 1: 10 g/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not specified
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 other: g/kg bw.
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 other: g/kg bw.
Based on:
test mat.
Mortality:
No mortality was observed after 24h and 14 days
Clinical signs:
no clinical toxicological symptoms
Body weight:
Body weight changes during the observation period showed a normal weight gain
Mean initial weight: 27.95 g
Mean terminal weight 33.53 g
Gross pathology:
no macroscopic findings (cranial-, thoracic- and abdominal cavity) after 14 days
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality, weight changes, clinical signs nor macroscopic findings were observed in male and female mice exposed to the test item at 10 g/kg. LD50 was therefore > 10 g/kg for both males and females
Executive summary:

The acute oral toxicity of PPC-H was investigated in one group of fasted male and female NMRI mice. The mice were exposed to a single oral dose of the test item (10 g/kg) and observed for 14 days post exposure.

No mortality, weight changes, clinical signs nor macroscopic findings were in male and female mice exposed to the test item (10 g/kg).

LD50 is therefore reported as > 10 g/kg for both males and females