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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-03-13 to 1990-03-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
version 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(trans-4-propylcyclohexyl)acetophenone
EC Number:
406-700-6
EC Name:
4-(trans-4-propylcyclohexyl)acetophenone
Cas Number:
78531-61-0
Molecular formula:
Hill formula: C17H24O CAS formula: C17H24O
IUPAC Name:
1-[4-(4-propylcyclohexyl)phenyl]ethan-1-one

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Chbb: THOM
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: about 7 to 9 weeks
- Weight at study initiation: 183 (174 - 193) g
- Fasting period before study: ca. 17 h before and 4 h after treatment
- Housing: Makrolon cages type III
- Diet: ad libitum, besides fasting period
- Water: ad libitum, besides fasting period, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 to 27
- Humidity (%):38 to 46
- Air changes (per hr): not detailed, but room air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 13.03.1990 - 27.03.1990

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.1 g/mL

MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg bw for 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 5 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observation: daily; body weight: on days 2, 4, 6, 8,11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The body weight data were processed by means of the program TOX 511 A, developed by the Department of Technical and Scientific Data Processing of E. Merck, Darmstad.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All the rats survived the observation period.
Clinical signs:
No intoxication symptoms were seen.
Body weight:
Body weight development of treated and control rats was normal.
Gross pathology:
In the rats which were all sacrificed at the end of the observation period no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, it is concluded, that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw following oral treatment in rats.
Executive summary:

In an acute oral toxicity study according to OECD 401, groups (5/sex) of Wistar Chbb: THOM rats, were given a single oral dose of the test item in methylcellulose at doses of 2000 mg/kg bw per gavage and observed for 15 days. The limit test with 2000 mg/kg showed no mortality. Body weight development of treated and control rats was normal. No abnormalities were detected during gross pathological examinations. For both sexes the LD50 was therefore determined to be > 2000 mg/kg bw.

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