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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study and sufficiently documented; study acceptable as key study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: clear fluid
- Storage condition of test material: without special regulations

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner, Sulzfeld, Germany
- Weight at study initiation: males 110-135 g, females 100-120 g
- Fasting period before study: 16 hrs before substance application until 4 hrs post application
- Housing: 5 per cage
- Diet: ad libitum before and after treatment
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1.0, 1.6, 2.5, 4.0 mL/kg corresponding to dosages of 1030, 1648, 2575, 4120 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical symptoms repeatedly on day of application, thereafter once daily;
body weight on the day of application and on study day 7 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 081 mg/kg bw
95% CL:
1 597 - 2 730
Mortality:
Details of time course of death at the different tested doses are presented in Table 1.
Except for 1 female rat of the highest dose group, all mortalities occurred within 24 hrs post application.
The LD50 was calculated at 2.02 mL/kg corresponding to 2081 mg/kg with a 95% confidence interval of 1.55-2.65 mL/kg (1597-2730 mg/kg).
Clinical signs:
Immediately after application all rats showed piloerection and bending
Further dose-related effects:
1030 mg/kg: decreased motility 10/10, staggering gait 10/10;
1648 mg/kg: decreased motility 1/5 m, 1/5 f; staggering gait 1/5 m, 3/5 f; most animals in prone position
2575 mg/kg: staggering gait 2/5 m; most animals in prone position
4120 mg/kg: most animals in prone position

Clinical symptoms at 2-14 days: piloerection as only symptom
Body weight:
Treatment had no effect on body weight development.
Gross pathology:
Deceased animals: slight to severe hyperaemia of the liver
Animals sacrificed at the end of the study: no pathological findings

Any other information on results incl. tables

Table 1: Time course of mortality findings

 Time point  Controls     1030 mg/kg   1648 mg/kg      2575 mg/kg    4120 mg/kg 
   m  f  m  f  m  f  m  f  m  f
 up to 6 hrs  0/5   0/5  1/5   1/5  2/5  0/5   1/5 3/5   3/5   2/5
 6 - 24 hrs   0/5   0/5   0/5   0/5   0/5   1/5   1/5   1/5   2/5  2/5
 24 - 48 hrs   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5
 3 - 7 d   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   1/5
 7 - 14 d   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5   0/5
 Total mortality   0/5   0/5   1/5   1/5   2/5   1/5   2/5  4/5  5/5  5/5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in rats was 2081 mg/kg bw. Death occurred within 24 hrs after application with unspecific clinical signs. Livers of deceased animals showed hyperemia.
Executive summary:

The acute toxicity was investigated in groups of 5 male and 5 female Sprague-Dawley rats by gavage application of undiluted acetophenone. The oral LD50 in rats was 2081 mg/kg bw. Death occurred within 24 hrs after application with unspecific clinical signs. Livers of deceased animals showed hyperaemia.