Registration Dossier

Administrative data

Description of key information

NaTG is toxic by ingestion. In contact with skin, NaTG can cause irritating effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
50 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 000 mg/kg bw
Quality of whole database:
LD50 determined with NaTG (LD50 is >1000 mg/kg bw for female rats.

Additional information

Thioglycolic acid and its salts are toxic by oral administration. When expressed as thioglycolate anion, the LD50values of thioglycolic acid and its salts are quite accurately in the same dose range.


Justification for selection of acute toxicity – oral endpoint
LD50 determined via ATC method with NaTG

Justification for classification or non-classification

Based on acute oral toxicity data in rats.

Classification:

DSD: T, R25. Toxic if swallowed.

EU-GHS: Acute tox cat. 3. H301. Toxic if swallowed.