Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2.2.1997 - 4.2.1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Other name: Ostazinová žluť H8-GSOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: 920/389 (sample supplied by the sponsor)- Expiration date of the lot/batch: unlistedSTABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: at laboratory conditions

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: with veterinary health certificate (no parasites/patogen microorganisms/mold); clinical examination confirmed the good state of health- Age at study initiation: not specified- Weight at study initiation: males 161 - 167g, females 162 - 165g- Fasting period before study: yes (20 hours before aplikation)- Housing: 5 male or 5 female in plastic polypropylene cages T4 (TOP Velaz Praha), sterilized wooden shavings; regular cleaning and disinfection- Diet: 10g/animal/day (standard granulated diet for rats ST-1; Bergman)- Water: ad libitum (tap water acc. ČSN 757111)- Acclimation period: 1 week- Fasting: 20 hours before oral aplicationENVIRONMENTAL CONDITIONS- Temperature (°C): 22±2- Humidity (%): 30 – 70%- Air changes (per hr): not specified- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20% suspension in water(based on weight of animal - volume 1 ml/100 g bw) MAXIMUM DOSE VOLUME APPLIED: 1 ml/100 g bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females/ dose in main studyThe difference in the weight of animals among a group not exceed 20%
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observation: after aplication, after 30 mins, after 3 hours, next day morning and afternoon, than dailyweighing: just before aplication and in the end of test- Necropsy of survivors performed: yes, macroscopic examination of muscles and organs (incl. their size, colour, shape, structure)- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:body weight and clinical signs (appearance of skin, fur, visible mucous membranes, nutritional status, psychic activity, somatomotoric activity, response to stimuli, lacrimation, examination of the function of the respiratory, digestive, urogenital and circulatory apparatus).

Results and discussion

Preliminary study:
The selection of dose 2g/kg bw was based on orientative dose finding study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat. (total fraction)
Mortality:
no mortality observed
Clinical signs:
no clinical signs of intoxication observed
Body weight:
weight gains in females were lower than their physiologic possibilities
Gross pathology:
no changes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
After a single oral administration of the test substance to laboratory rats (2g/kg bw) no signs of intoxication were detected by clinical and pathological examination.
Executive summary:

In the sample Ostazinová žluť H8-G, the acute oral toxicity test was performed on the Wistar rats.

Examination of acute oral toxicity revealed that the rat LD50 was greater than 2000 mg/kg of body weight.

The acute oral toxicity testing was performed according to OECD methodology No. 401.