Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-03-26 to 1985-04-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 401) performed under GLP-like quality controlled conditions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
Predating compulsory compliance to GLP, QA statement included
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: commercial grade
- Description: solid

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALs
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 172 - 204 g
- Fasting period before study: overnight, prior to dosing
- Housing: Conventional laboratory conditions, caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin).
- Diet: ad libitum, except for the night prior to dosing
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: temperature 22±3° C
- Humidity: relative humidity 55±15%,
- Air changes: approximately 15 air changes/h
- Photoperiod: 12 hours light/day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
-Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.).
- Amount of vehicle (if gavage): 20 mL/kg bw
Doses:
Single dose: 5000 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:
mortality: daily; a.m. and and p.m. on working days, a.m. on weekend days
clinical signs: once daily
- Frequency of body weight measurements: on days 1, 7, and 14
- Necropsy of survivors performed: yes, at the end of the observation period
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. The animals recovered within 13 days.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The oral LD50 in the rat is greater than 5000 mg/kg body weight.
Executive summary:

In an oral toxicity study according to OECD guideline 401, 5 male and 5 female rats were dosed once with the test article by gastric intubation at a dose level of 5000 mg/kg body weight and observed for 14 days. The vehicle used was distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80. There were no deaths. Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests. The animals recovered within 13 days. All rats remained healthy and gained weight by day 14 of the study. All animals appeared normal at necropsy. Under the conditions of this study, the LD50 is greater than 5000 mg/kg bw in male and female rats when applied orally.