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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 5 August 1991 to 28 October 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Details on test material:
- Physical state: clear yellow liquid
- Stability under test conditions: stable
- Storage condition of test material: Between 20-30ºC in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 197-218 g
females: 155-169 g
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/Kg body weight
No. of animals per sex per dose:
5 males
5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality
Mortality:
No mortality occurred during the study period
Clinical signs:
No clinical signs of ill health or behavioural changes were seen during the test
Body weight:
The body weight was considered to be similar
Gross pathology:
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities

Any other information on results incl. tables

INDIVIDUAL ANIMAL OBSERVATIONS - MALES

Dose Level (mg/kg) Observations Number showing effects during day of exposure (hours) Number showing effects during day of observation Total mortality
0,05 2,1 4,15 2 3 4 5 6 7 8 9 10 11 12 13 14 15  
2000 No abnormalities 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5  
Deaths 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0/5

INDIVIDUAL ANIMAL OBSERVATIONS - FEMALE

Dose Level (mg/kg) Observations Number showing effects during day of exposure (hours) Number showing effects during day of observation Total mortality
0,05 2,1 4,15 2 3 4 5 6 7 8 9 10 11 12 13 14 15  
2000 No abnormalities 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5  
Deaths 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0/5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/Kg body weight.
Executive summary:

This study was entitled "Assessment of acute oral toxicity with the substance in the rat". The study was carried out in accordance with the OECD Guideline No. 401, “Acute Oral Toxicity” and EEC Directive 84/449/EEC, Par B.1, “Acute Toxicity-Oral”. No clinical signs of ill health or behavioural changes were observed during the study and no macroscopic abnormalities were seen at necropsy. The oral LD50 value of the substance in rats of either sex was established as exceeding 2000 mg/kg body weight.

The substance cannot be classified and has no obligatory labelling requirement.