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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann
- Mean weight at study initiation per test group: 170-260 g (males), 170-190 g (females)
- Fasting period before study: 15-20 h
- Diet: Herilan MRH-Haltung, H. Eggersmann KG; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous 0.5% CMC solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4.64 - 50%

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
464, 2150, 3160, 3830, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not applicable
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 4, 7 and 13. Observation of clinical signs was done several times on the day of administration and once daily afterwards with the exception of weekends and on holidays
- Necropsy of survivors performed: yes
Statistics:
According to Finney, D.J.: Probit Analysis, Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 210 mg/kg bw
Based on:
test mat.
95% CL:
2 755 - 3 600
Mortality:
5000 mg/kg bw: 10/10 animals (5/5 males died within one day; 4/5 females died within one day, the last female within 7 days)
3830 mg/kg bw: 7/10 animals (2/5 males died within 7 days; 5/5 females died within one day)
3160 mg/kg bw: 6/10 animals (2/5 males died within one day; 4/5 females died within one day)
2150 mg/kg bw: 0/10 animals
464 mg/kg bw: 0/10 animals
Clinical signs:
5000 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atonia, narcotic-like behaviour, missing pain reflex, twitching, skin redness, ruffled fur, exsiccosis and poor general state before exitus

3830 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atonia, twitching, convulsions, skin redness, ruffled fur and poor general state before exitus; survivors recovered within 4 days

3160 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atonia, skin redness, ruffled fur and poor general state before exitus; survivors recovered within 4 days

2150 mg/kg bw: dyspnoea, apathy, spastic movement, tremor and poor general state; animals recovered within 4 days

464 mg/kg bw: no clinical signs
Body weight:
Mean body weight:
Males:
- 5000 mg/kg bw: (day 0) 170 g
- 3830 mg/kg bw: (day 0) 210 g, (day 4) 237 g, (day 7) 265 g, (day 13) 304 g
- 3160 mg/kg bw: (day 0) 210 g, (day 4) 238 g, (day 7) 265 g, (day 13) 296 g
- 2150 mg/kg bw: (day 0) 260 g, (day 4) 290 g, (day 7) 312 g, (day 13) 339 g
- 464 mg/kg bw: (day 0) 240 g, (day 4) 287 g, (day 7) 301 g, (day 13) 328 g

Females:
- 5000 mg/kg bw: (day 0) 170 g
- 3830 mg/kg bw: (day 0) 170 g
- 3160 mg/kg bw: (day 0) 170 g, (day 4) 166 g, (day 7) 169 g, (day 13) 194 g
- 2150 mg/kg bw: (day 0) 190 g, (day 4) 206 g, (day 7) 210 g, (day 13) 224 g
- 464 mg/kg bw: (day 0) 190 g, (day 4) 213 g, (day 7) 221 g, (day 13) 236 g
Gross pathology:
Animals that died: dilatation of the urinary bladder, oedemateous liver parenchym, single hemorrhagic erosions of the gastreous mucosa
Sacrificed animals: no abnormalities

Applicant's summary and conclusion