Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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: Study conducted according to internationally accepted testing guidelines.

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:
Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.
GLP compliance:
no
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 (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 160 to 180 g.
- Fasting period before study: the rats were starved during one night before starting the treatment.
- Housing: segregated and housed in MacroIon cages (Type 3) in groups of 5.
- Diet: ad libitum, rat food, NAFAG, Gossau SG.
- Health: healtly rats.
- Water: ad libitum.
- Acclimatization: at leas 4 days.

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
TEST SOLUTION
- Preparation: before treatment the suspension was homogeneously dispersed with an Ultra-Turrax.
- During treatment: the suspension was kept stable with a magnetic stirrer.
Doses:
3170, 4640, 6000, 7750 and 10000 mg/kg bw
No. of animals per sex per dose:
20 males and 20 females; 5 x sex x dose.
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes; survivors killed and autopsied after an observation period of 14 days.
Statistics:
LD50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 562 mg/kg bw
Based on:
test mat.
95% CL:
6 651 - 8 598
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose
mg/kg
Conc. % of formulation N. of animals Died within
1 hr 24 hrs 48 hrs 7 days 14 days
M F M F M F M F M F M F
3170 30 5 5 0 0 0 0 0 0 0 0 0 0
4640 50 5 5 0 0 0 0 1 0 1 0 1 0
6000 50 5 5 0 0 0 1 0 1 0 1 0 1
7750 50 5 5 0 0 3 2 3 2 3 2 3 2
10000 50 5 5 1 2 4 5 4 5 4 5 4 5

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: 7562 (95 % CL: 6651-8598) mg/kg bw
Executive summary:

Method

Rats were dosed at concentrations of 3170, 4640, 6000, 7750 and 10000 mg/kg bw and observed for 14 day post-treatment period in order to evaluated the substance acute oral toxicity.

Result

LD50: 7562 (95 % CL: 6651-8598) mg/kg bw.

Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved or ventral position and ruffled fur. The survivor animals recovered within 7 to 8 days.