Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to internationally accepted testing guidelines. Further details in the endpoint summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: First attachments of 30 July 1996 DIRECTIVE 96/54/EC (L 248)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: authorized vendor
- Weight at study initiation: 175 ± 5 g
- Housing: Makrolon cage (48 x 27 x 20 cm), with bedding of wood chips.
- Diet: free access to an experimental diet for rats, provided by an accredited supplier.
- Water: tap water bottles ad libitum
- Acclimation period: 7 days
- Health check: during acclimatation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (± 2°C).
- Humidity (%): 55% (± 25%)
- Air changes (per hr): 15 air change per hour with filtered air (5 µm)
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg for 20 ml of water
- Amount of vehicle : 2 ml of solution for 100 mg of body weight





Doses:
2000, 200, and 25 mg/Kg bw
No. of animals per sex per dose:
3 animals per each sex per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Skin, hair, eyes, mucous membranes, respiratory, circulatory system, central and autonomic nervous system, somatomotor activity and behavior patterns. Particular attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 1 500 mL/kg bw
Based on:
act. ingr.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 mg/kg bw
Based on:
act. ingr.
Mortality:
no mortality observed
Clinical signs:
no clinical signs observed
Body weight:
no body weight lost
Gross pathology:
no patology observed after necropsy

Any other information on results incl. tables

sacrifice:

All survived animals are killed by CO2 administration

The test was conducted as a limit test, since no mortality was recorded, no further test or analysis are necessary

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was tested with a limit test method and acute oral toxicity for rats is LD50 > 1500 mg/kg bw based on active ingredient
Executive summary:

The substance was tested for acute toxicity on Wistar rats. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw. The substance is not toxic for oral administration.