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Diss Factsheets

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
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 regulations

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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.

No tests are available with the substance Reaction mass of acetophenone and hydratropaldehyde and (E)-1,4-diphenyl-2-butene-1,4-dione. However, the main constituent Acetophenone is regarded as most relevant for the evaluation of the multi constituent substance. Therefore, the results of the test with Acetophenone were presented. The procedure laid down in the CLP regulation (1272/2008/EG) to base the classification and labeling on the available data and classification of the known main and relevant constituents was used. A detailed description of the evaluation used for this endpoint can be found in the "Endpoint summary" for "Acute toxicity". Based on this evaluation no further testing is indicated to be necessary.

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