Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1980-02-27 to 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to OECD Guideline 401 (Acute Oral Toxicity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4-phenylbutan-2-one
EC Number:
219-847-4
EC Name:
4-phenylbutan-2-one
Cas Number:
2550-26-7
Molecular formula:
C10H12O
IUPAC Name:
4-phenylbutan-2-one
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Benzyl acetone
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Acce Animals
- Age at study initiation: 8 weeks old
- Weight at study initiation: 160-235 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
2.47, 3.12, 3.95, 5.0, 6.33 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3-4 hours after dosing and once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
The LD50 was calculated according to the method of Litchfield JTJ & Wilcoxon F, JPET 96-99, 1949.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 200 mg/kg bw
Based on:
test mat.
95% CL:
2 300 - 4 450
Mortality:
In 2.47 g/kg bw dose group, two animals died on day one. In 3.12 g/kg bw dose group, one animal died 3-4 hours post dose, three animals on day one and one animal on day 6. In 3.95 g/kg bw dose group, two animals died 3-4 hours post dose, five on day one and one on day 6. In 5.0 g/kg bw dose group, four animals died 3-4 hours post dose and three on day one. In 6.33 g/kg bw dose group, six animals died 3-4 hours post dose and three on day one.
Clinical signs:
Lethargy, piloerection and ptosis were observed in all dose groups. Chromorhinorrhea was observed in all dose groups except the high dose group. Prostration or coma were generally noted prior to death.
Body weight:
no data
Gross pathology:
At necropsy congested or hemorrhagic lungs, emphysema, dilated hearts and gastrointestinal distentions were noted in most deaths. Survivors were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was acutely non toxic to rats in an acute oral toxicity test with an LD50 value of 3200 mg/kg bw. The substance is not classified according to CLP.
Executive summary:

Ten healthy male Wistar rats with initial body weights between 168-226 grams per dose level were used. Animals were fasted 16-20 hours prior to dosing. Otherwise, food and water was available freely. Observations for mortality and/or systemic effects were made 3-4 hours post dose and daily thereafter for 14 days. Surviving animals were sacrificed on day 14. A gross necropsy was conducted on all animals. The LD50 was calculated according to the method of Litchfield and Wilcoxon, 1949, is 3.2 (2.30-4.45) g/kg. In 2.47 g/kg bw dose group, two animals, in 3.12 g/kg bw dose group 5 animals, in 3.95 g/kg bw dose group 8 animals, in 5.0 g/kg bw dose group 7 animals and in 6.33 g/kg bw dose group 9 animals died within the observation period. Prostration or coma were generally noted prior to death.