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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedures are well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The acute oral LD50 of the test substance in rats of both sexes was tested administrating the test item by gavage at doses of 6000, 7750 and 10000 mg/kg bw; the animals were observed over a period of 14 days.
GLP compliance:
not specified
Remarks:
Pre GLP.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: testing laboratory.
- Weight at study initiation: 160 to 180 grams.
- Fasting period before study: animal fasted overnight.
- Housing: housed in group of 5 in Macrolon cages (type 3).
- Diet: ad libitum, rat food NAFAG, Gossau SG.
- Water: ad libitum.
- Acclimation period: for a minimum of 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 14 hrs light cycle day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 %
- Preparation of the solution: the suspension was homogeneously dispersed with Ultra-Turrax and during it was kept stable with magnetic stirred.
Doses:
6000, 7750, 10000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose.
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 days.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose mag/kg Conc. % of formulation  N. of animals Died within
1 h 24 hrs 48 hrs 7 days  14 days
F M F M F M F M F M F M
6000 50 5 5 0 0 0 0 0 0 0 0 0 0
7750 50 5 5 0 0 0 0 0 0 0 0 0 0
10000 50 5 5 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
LD50 > 10000 mg/kg bw
Executive summary:

Method

The acute oral LD50 of the substance in rats of both sexes was tested administrating the test item by gavage at doses of 6000, 7750 and 10000 mg/kg bw; the animals were observed over a period of 14 days.

Results

No deaths occurred. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. The animals recovered within 8 days.

LD50 > 10000 mg/kg bw