Registration Dossier
Registration Dossier
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EC number: 202-708-7 | CAS number: 98-86-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Acetophenone
- EC Number:
- 202-708-7
- EC Name:
- Acetophenone
- Cas Number:
- 98-86-2
- Molecular formula:
- C8H8O
- IUPAC Name:
- 1-phenylethanone
- Details on test material:
- - Physical state: clear fluid
- Storage condition of test material: without special instructions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system 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 2,081 mg/kg with a 95% confidence interval of 1.55-2.65 mL/kg (1,597-2,730 mg/kg). - Clinical signs:
- other: 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 a
- Gross pathology:
- Deceased animals: slight to severe hyperemia 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:
- Category 5 based on GHS criteria
- Conclusions:
- The oral LD50 in rats was 2,081 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 hyperemia.
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