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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Substance type: red solid
- Physical state: solid
- Analytical purity: approx 100%
- Purity test date: no data
- Lot/batch No.: 4235
- Expiration date of the lot/batch: March 10, 1990
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: males: 9 weeks, females: 11 weeks
- Weight at study initiation: ma 1es : 211 - 231 g, females: 175 - 195 g
- Fasting: overnight (12 - 18h)
- Housing: five rats per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
Temperature (°C): 22 +-3 degrees centigrade
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1989-04-05 To: 1989-04-19

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/10 ml
- Amount of vehicle (if gavage): 10 ml/kg bw

Doses:
2000 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 and weighing: Clinical signs and mortality: Four times during test day 1, and daily during days 2-15; Body weights Test days 1 (pre-administration) , 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred
Mortality:
none
Clinical signs:
behavior: sedated (10), gait/motility: uneoordinated movements (10), skin/fur: ruffled fur (10).. All rats had recovered within three observation days.
Body weight:
not affected
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU