Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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: 161-201 g
- Age: 7-8 weeks
- Fasting period before study: 22 h
- Housing: single animale per cage
- Diet: commercial rat food, NAFAG No. 890, NAFAG AG, Gossau CH ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 55 ± 15 %
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
- approx. 15 air changes/h










Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Single dose: 2000 and 5000 mg/kg of the compound bw.
Volume: 10 ml/kg for lower dose and 20 ml/kg for higher dose
No. of animals per sex per dose:
5 for each sex
Total animals number : 20
Control animals:
not specified
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
All the animals of both sexes in the 5000 mg/kg groups died after 1 day of the post-exsposure period.
Clinical signs:
Dyspnea, slight to moderate ruffled fur and abnormal body positions were seen, being common symptoms in acute tests.
Additionally diarrhea was detected in the animals of the 2000 mg/kg dose group up to day 2 after the administration.
Sedation and diarrhea was observed in the animals of the 5000 mg/kg bw dose group.
Body weight:
Determined at day: 1, 7 and 14 and at each death.
Gross pathology:
No change in any organs and tissues.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Classification criteria according to the CLP Regulation 1272/2008 and its amendments
Conclusions:
LD50 > 2000 mg/kg bw.
Executive summary:

The results show no toxicity with a LD 50 value > 2000 mg/kg.