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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report

Data source

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

Materials and methods

Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
EC Number:
208-205-9
EC Name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
Cas Number:
515-69-5
Molecular formula:
C15H26O
IUPAC Name:
6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol
Test material form:
other: liquid
Details on test material:
Name of the test substance used in the study report: (+-)-alpha-Bisabolol (liquid)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 15- 20 h before administration
- Diet: a standardized animal laboratory diet


Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
Form of administration; emulsion; 0.5% aqueous carboxymethyl cellulose with 1 - 2 drops of Cremophor EL
Concentrations used: 2, 4.64, 7 and 10%
Administration volume: 10 mL/kg
Doses:
200, 464, 700, 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
633 mg/kg bw
Mortality:
Male animals:
200 mg/kg: 0/5 D14;
464 mg/kg: 1/5 D14;
700 mg/kg: 5/5 D14;
1000 mg/kg: 5/5 D14;

Female animals:
200 mg/kg: 0/5 D14;
464 mg/kg: 1/5 D14;
700 mg/kg: 2/5 D14;
1000 mg/kg: 3/5 D14;
Clinical signs:
Dyspnea, apathy, abnormal position, staggering gait, trembling, stretching, rolling fits, ruffled fur, erythema, exsiccosis, fascicular twitching, ptosis, paresis, poor general state
Body weight:
Mean body weight male animals:
Dose group 200 mg/kg: 22 g at study start; 25.8 g at D13
Dose group 464 mg/kg: 26 g at study start; 30 g at D13
Dose group 700 mg/kg: 30 g at study start; 21.5 g at D7
Dose group 1000 mg/kg: 30 g at study start; 23.8 g at D2-4

Mean body weight female animals:
Dose group 200 mg/kg: 20 g at study start; 25.6 g at D13
Dose group 464 mg/kg: 24 g at study start; 26.3 g at D13
Dose group 700 mg/kg: 26 g at study start; 29.3 g at D7
Dose group 1000 mg/kg: 24 g at study start; 25 g at D2-4
Gross pathology:
Animals that died: No intraabdominal deposits of the test substance or adhesions.
Sacrificed animals: liver: intraabdominal adhesions; liver margins blunt; serosa adstringed

Applicant's summary and conclusion