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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
Study period:
1980-04-10 and 1980-05-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to OECD guideline 401, non-GLP conform study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
FAT 11181/A
IUPAC Name:
FAT 11181/A
Test material form:
other: solid

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight
- Housing: housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: ad libitum; NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2
- Humidity (%): 55 + 10
- Photoperiod: 10 hours light cycle day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg, 20 mL/kg

Doses:
1000, 2000, 3000, 5000 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: Physical condition and rate of deaths were monitored throughout the whole observation period
- Frequency of weighing: immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 900 mg/kg bw
Based on:
test mat.
95% CL:
2 257 - 3 997
Mortality:
see any other information on results
Clinical signs:
Sedation, dyspnoea, ruffled fur, diarrhoea and a curved body position was observed at concentrations of 1000, 2000 and 3000 mg/kg.
At the highest concentration of 5000 mg/kg ventral and lateral body positions were additionally observed.
Body weight:
Females: Body weight determined on day 1, 7 and 14 remained unchanged.
Males: Slight body weight gain was observed on day 1, 7 and 14 in a concentration range of 1000 - 5000 mg/kg.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of Deaths

Dose mg/kg

Sex

Total number animals in group

Total Number animals dead

Death rate percentage

Time of death after dosing

Hours after dosing

Days after dosing

1

2

3

5

24

2

3

4

5

6

7

14

1000

male

5

0

0

 

 

 

 

 

 

 

 

 

 

 

 

2000

5

2

40

 

 

 

 

2

 

 

 

 

 

 

 

3000

5

2

40

 

 

 

 

2

 

 

 

 

 

 

 

5000

5

4

80

 

 

 

3

 

 

 

 

 

1

 

 

1000

female

5

0

0

 

 

 

 

 

 

 

 

 

 

 

 

2000

5

0

0

 

 

 

 

 

2

 

 

 

 

 

 

3000

5

3

60

 

 

 

 

1

 

 

 

 

 

 

 

5000

5

5

100

 

 

1

4

 

 

 

 

 

 

 

 

Applicant's summary and conclusion