Registration Dossier

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: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Standardised test to assess the acute toxicity of the test substance after i.p. application in mice (BASF-Test).
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anisaldehyd
- Physical state: liquid
- Analytical purity: > 99 % (data from order sheet)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Mean weight per test group at study initiation: 22-28 g (males); 22-24 g (females)
- Fasting period before study: 15-20 h
- Diet: Herilan MRH-Haltung, H. Eggersmann KG ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous 0.5% CMC solution
Details on exposure:
VEHICLE
- Concentration in vehicle: 2% - 20%

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
200, 700, 2000 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
- Frequency of observations and weighing: Weighing was performed at the beginning of the study and on days 3-4, 7 and 13. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 700 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw: 10/10
700 mg/kg bw: 0/10
200 mg/kg bw: 0/10
Clinical signs:
2000 mg/kg: dyspnoea, apathy, abnormal position, staggering, atonia, loss of cornea reflex, twitching, narcotic like state, poor general condition

700 mg/kg: dyspnoea, apathy, abnormal position, staggering, twitching, tremor, poor general condition

200 mg/kg: no adverse effects
Body weight:
The body weight gain was within the normal range.
Gross pathology:
Animals that died or were sacrificed after post observation period: no intra-abdominal substance precipitations or adhesions.

Applicant's summary and conclusion