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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:
2003
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid form
Details on test material:
Lot/batch No.:2619427

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: autorised supplier
- Age at study initiation: young and healthy rats
- Weight at study initiation: 208 to 231 g
- Fasting period before study:
- Housing: Makrolon (48 x 27 x 20 cm) Tecniplast brand.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° C ( ± 2 °C)
- Humidity (%): 55% (±25%)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/2

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The sample is diluted 1/10 with water
MAXIMUM DOSE VOLUME APPLIED: 1.69 ml per 100 g of body weight, equivalent to 2000mg/kg bw
Doses:
2000 mg/kg
This is a limit test, and the information available suggests that the substance is practically non toxic. If after 14 days of the test there isn't mortality observed the test can be finished.
No. of animals per sex per dose:
3 males and 3 females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: every day
- Necropsy of survivors performed: yes
- Other examinations performed: skin, hair, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavioral patterns.
-Special attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
Not observed
Clinical signs:
All behaviours registered are considered normal. Not toxicity signs are atributed to the administration of the test material
All animals administered, alive with normality until 14 observation days.
Body weight:
The body weight variation registered is considered normal.
Gross pathology:
Observation at necropsy didn't show significant macroscopic changes in any of the animals.

Any other information on results incl. tables

Mortality in the limit test (male rats, 2000 mg/kg)

 Rat n°  Volum administered  Initial  Death  Remarks
 ML1  3.6  03/01/03  17/01/03  Sacrified to 14 days
 ML2  3.9  03/01/03  17/01/03  Sacrified to 14 days 
 ML3  3.5  03/01/03  17/01/03  Sacrified to 14 days 

Mortality in the limit test (female rats, 2000 mg/kg)

 Rat n°  Volum administered  Initial  Death  Remarks
 ML1 2.8  31/12/02  14/01/03  Sacrified to 14 days
 ML2 2.9   31/12/02   14/01/03  Sacrified to 14 days 
 ML3 2.9   31/12/02   14/01/03  Sacrified to 14 days 

Weight in the limit test (male rats, 2000 mg/kg)

 
 Weight in grams
 
Rat  Initial  7° day Final  Remarks 
ML1 215 280 309 ---
ML2 231 297 320  --- 
 ML3   208  284 313   ---

Weight in the limit test (female rats, 2000 mg/kg)

 
 Weight in grams
 
Rat  Initial  7° day Final  Remarks 
ML1 164 198 207 ---
ML2 170 195 214  --- 
 ML3  171 198  215  ---

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The tested substance presents an acute toxicity by oral route in rats of LD50 >2500 mg/kg.
Executive summary:

After 7 days of acclimatization, a limit dose of 2000 mg/kg bw was administered in several phases in order to analise the presence of letality to 6 rats (3 males and 3 females).

An individual weight control and general examinations during the observation period of 14 days were performed.

It can be concluded that the tested substance presents an acute toxicity LD 50 >2500 mg/kg according to the results presented in the study.