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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Remarks:
RCC Ltd. Toxicology Division, CH-4452 Itingen/Switzerland
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)
Specific details on test material used for the study:
- Name of the test material: JODOSEPT L- Batch No. ZK 1055/175-2- ZHT no: 98/429-1- Storage: In the original container at room temperature, away from direct sunlight

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf/Switzerland- Age at study initiation: males 8 weeks, females 10 weeks- Weight at study initiation: males 209.5 – 220.5 g, females 167.9 – 182.8 g- Fasting period before study: overnight prior to intubation (approx. 17 h)- Housing: in groups of three in Makrolon type-4 cages with standard softwood bedding (“Lignocel”, Schill AG, CH-4132 Muttenz)- Diet: Pelleted standard Kliba 3433, batch no. 28/98, rat maintenance diet (Kliba Mühlen AG, CH-4301 Kaiseraugst) available ad libitum- Water: community tap water from Itingen, ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3 - Humidity (%): 40 - 70 - Air changes (per hr): 10 - 15 - Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
bi-distilled
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20% (w/v) - Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and check for viability: four times during test day 1 and once daily for surviving animals during days 2-15.- Frequency of weighing: On test day 1 (pre-administration), 8 and 15 for surviving animals.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs were checked once daily.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the study.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight of the animals was within the range of physiological variability known for rats of this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met