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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
Study period:
from 31 August to 01 December 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
Description: sodium thioglycolate 98 %
Batch number: B00S5974
Purity: 99.9 %
Stability: Stable under storage conditions, under nitrogen
Stability of test item: Stable in bi-distilled water for a least 30 minutes.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
ANIMALS
- Source: RCC, Ltd, Biotechnology & Animal breeding division,  Wölferstrasse, 4 CH-4414 Füllinsdorf , Switzerland.
- Age: 8-10 weeks
- Weight:  217.1-234.7 g (M), 158.9-181.9 g (F)
- Acclimatization: 1 week
- Housing: 3 per sex
- Diet: ad libitum Pelleted standard Kliba 3433, batch n° 03/00 and 04/00,  rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst)
- Water: ad libitum tap water

CONDITIONS:
- Air changes: 10-15/hour
- Temperature: 21-23.5 °C
- Relative Humidity: 36-57%
- Light-Dark cycle: 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Vehicle: bi-distilled water. Source: RCC Ltd Stability: stable under storage conditions. Storage conditions: at room temperature (20+/-3°C), away from direct sunlight
Details on oral exposure:
The animals received a single dose of the test item on a 200 , 50 or 25  mg/kg bw by oral gavage following fasting for approx. 17 hours, but with  free access to water. Food was provided again 3 hours after dosing. 
Doses:
25, 50 and 200 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Animals were observed once daily during the acclimatization phase and  then 1, 2, 3 and 5 hours after administration on day 1 and twice daily  for surviving animals during days 2-15. Surviving animals were weighted on day 1, 8 and 15. All abnormalities and  clinical signs were recorded. All animals were necropsied and examined macroscopically.
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
50 - 200 mg/kg bw
Based on:
test mat.
Mortality:
All males and females treated at 25 and 50 mg/kg survived until scheduled  necropsy. Two out of 3 females treated at 200 mg/kg died on day 1. The following animals were treated and percentage mortality was observed:                          
Males         Females
Group 1 (200 mg/kg)                 66%        
Group 2 (50 mg/kg)                 0%
Group 3 (50 mg/kg)        0%
Group 4 (25 mg/kg)                 0%
Group 5 (25 mg/kg)         0%
Clinical signs:
No clinical signs were observed during the observation period in all 50  mg/kg treated males and females and all 25 mg/kg treated females.
Slightly ruffed fur was observed in all 200 mg/kg treated females from 1  to 3 hours (2 females) or from 1 or 5 hours (1 female) after treatment.  Ventral recumbency was observed at the 3-hour observation in two females  and one of the two females showed respiratory distress. Hunched posture  was additionally noted in the third female from 3 to 5 hours after the  treatment. Slightly ruffled fur was observed in all 25 mg/kg treated  males from 3 to 5 hours after the treatment and persisted on day 2. 
Body weight:
On female treated at 25 mg/kg showed a marked loss of body weight (26 %)  one week after the treatment. It had recovered at the end of the  observation period.
Gross pathology:
A distended stomach with gas was observed at the unscheduled necropsy in  two females treated at 200 mg/kg. No macroscopic findings were observed  at the other scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The median lethal dose is between 50 and 200 mg/kg in rat after a single oral administration in both sexes.