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
Study period:
25th May to 27th July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Betadet SHR
Lot number: 7049
Appearance: viscous yellowish liquid
pH: 7.48
Storage: Room temperature; protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Weight on arrival: 80-95g
Age on arrival: Approximately 4 weeks
Source: Charles River, supplied by Criffa, S.A
Housing: Makrolon cages with sawdust bedding, up to 5 rats of same sex
Acclimatisation period: At least 5 days
Weight at start of study: 100g (preliminary study); 107-122g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86% (generally within 40-70%)
Photoperiod: 12 hours light/dark cycle
Diet: Standard rat diet UAR A04C, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, S.A; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
In the preliminary study, one female was dosed with 2000 mg/kg bw .In the main study, five males and five females were dosed with 2000 mg/kg bw. Animals were fasted 18 hour prior to treatment. The test substance was administered orally by gastric intubation using a metal catheter. The solutions were prepared immediately prior to dosing. A single dose was given at a volume of 10 mL/kg bw. The quantity was based on bodyweight at the time of dosing. Food was replaced three hours following dosing.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five (additional female used in preliminary study).
Control animals:
no
Remarks:
not required
Details on study design:
The rats were observed at least twice daily for 7 days (preliminary study) or for 14 days (main study), after which they were sacrificed. Observations included changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous systems, somatomotor activity and behaviour patterns.
Body weights were recorded before administration, daily for the first three days, then weekly and prior to being sacrificed. Rats were sacrificed by carbon dioxide inhalation. The animals in the main study were subjected to necropsy. The necropsy included a revision of the intact animal and its superficial tissues, followed by observation of the cranial, thoracic and abdominal cavities in situ and after evisceration.

Results and discussion

Preliminary study:
No mortality was observed. The female presented soft faeces on the day following treatment. No other clinical signs were noted. The animal showed normal body growth.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
No deaths occurred at the limit dose of 2000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted.
Body weight:
All animals showed normal growth.
Gross pathology:
No visible macroscopic lesions were noted which were treatment related.

Any other information on results incl. tables

No deaths occurred at the limit dose of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No deaths were observed in this study at the limit dose of 2000 mg/kg bw. Slightly soft faeces were noticeable on the day following treatment. No other clinical signs were noted. The substance is not classified for acute oral toxicity under CLP.
Executive summary:

An acute oral toxicity study with Betadet SHR was conducted using a fixed dose method. Wistar rats were dosed with 2000 mg/kg bw. A preliminary experiment comprising one female showed no mortality. Soft faeces were noted on the day following treatment. No other clinical signs were noted during the seven day observation period. A main experiment comprised five animals/sex. Soft faeces were noted on the day following treatment. There were no other clinical signs, mortality or post mortem observations. Body weight gain was normal. The overall conclusion of the study was that the test material showed no significant signs of toxicity. The substance is not classified for acute oral toxicity under CLP.