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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 30, 1984 - Dec 14, 1984
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:
(1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)
EC Number:
619-269-6
Cas Number:
97398-80-6
Molecular formula:
C₁₆H₃₀O
IUPAC Name:
(1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Wi-AF/Han (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: E. Merck, Darmstadt, Germany
- Age at study initiation: young
- Weight at study initiation: 157 (150 - 164) 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, Altromin Standard Diet TPr 1324
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 26
- Humidity (%): 40 to 49
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Test Group: 6.0 mL/kg (equal to 5520 mg/kg bw)
Control Group: 5 mL/kg 0.25 % Methocel K4M Premium
No. of animals per sex per dose:
total 10: 5 (m) / 5 (f)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and 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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 mL/kg bw
Based on:
test mat.
Remarks on result:
other: eq.: > 5520 mg/kg bw based on density of 0.92
Mortality:
All rats survived the observation period.
Clinical signs:
other: No signs of toxicity were seen after treatment with 6 mL/kg.
Gross pathology:
The gross pathological examination revealed no organ alterations.

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 6 mL/kg (> 5000 mg/kg bw) after single oral administration in rats.
Executive summary:

In this study, the acute toxicity of the test material in rats after single oral administration of 6 mL/kg (equal to 5520 mg/kg bw) body weight was investigated. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 401. No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with the test item.
There was a small difference in body weight gain between treated and control group on the second day of the study. Otherwise the body weight development of the rats was inconspicuous during the study.
There were no deaths during the course of the study.
The gross pathological examination revealed no organ alterations.

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 6 mL/kg bw after single oral administration in rats.