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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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