Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Mar 12 - May 15, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene
EC Number:
605-718-3
Cas Number:
174350-05-1
Molecular formula:
C17H24F2O
IUPAC Name:
1-ethoxy-2,3-difluoro-4-[(1s,4r)-4-propylcyclohexyl]benzene
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: F. Winkelmann, Borchen, Germany- Age at study initiation: 5 to 8 weeks - Weight at study initiation: 172 (158 - 186) g - Fasting period before study: 17 hours before until up to 4 hours after treatment- Housing: separately in type III Makrolon cages - Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS- Temperature (°C): 20 to 21 °C - Humidity (%): 54 to 68 %- Photoperiod (hrs dark / hrs light): 12 hour light - 12 hour dark regimeIN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methocel K4M Premium solution
Details on oral exposure:
VEHICLE- Concentration in vehicle: 100 g/L- Amount of vehicle (if gavage): 20 mL/kg- Justification for choice of vehicle: excellent vehicle performance in long range historical dataMAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations: for at least 6 hours after administration and then daily up to end of study- Frequency of weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.- 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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All rats survived the observation period.
Clinical signs:
No signs of toxicity were seen in the 3 male and 3 female rats after treatment with 2000 mg/kg.
Body weight:
On female rat showed inhibition of body weight development. The body weight development of the other rats was inconspicuous during the study.
Gross pathology:
The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
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 2000 mg/kg after single oral administration in rats.