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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 18, 1984 - January 22, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
EC Number:
283-130-2
EC Name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl
Cas Number:
84540-37-4
Molecular formula:
C23H30
IUPAC Name:
trans-4-ethyl-4'-(4-propylcyclohexyl)-1,1'-biphenyl

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Breeder: E. Merck, Darmstadt, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: 161 g (152 - 171 g)
- Fasting period before study: 17 hours before until up to 4 hours after treatment
- Housing: separately in type III Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 26°C
- Humidity (%): 36-45%
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
Methocel K4M Premium solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 g/L
- Amount of vehicle (if gavage): 50 ml/kg
- Justification for choice of vehicle: well tolerated and established standard vehicle

Doses:
5000 mg/kg
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: day 1, 2, 4, 6, 8, 11, 13 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All rats survived the observation period.
Clinical signs:
The intoxication symptoms set in 1 - 2 hours after treatment and persisted on the first day of the study. The symptom observed were reduced spontanuous activity.
Body weight:
There was no difference between treated and control rats
Gross pathology:
In the rats which were killed on day 15, all findings were incidental in nature and not attributable the administration of the test material.

Any other information on results incl. tables

Study design

The test material was tested for acute toxicity in rats after single oral administration of 5000 mg/kg body weight. Directly before administration the test material was prepared with aqueous Methocel K4M Premium solution as the vehicle.

Results

No signs of intoxication were observed after treatment. A limit test (5000 mg/kg) showed no mortality, and thus there was no need for a LD50 determination and calculation.

Conclusion

For regulatory purposes, the median lethal dose (LD50) for males and females, after an observation period of 15 days, may be listed as >5000 mg/kg.

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 material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in rats.
Executive summary:

This study was performed according to GLP. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 5000 mg/kg after single oral administration in rats.