Sodium mercaptoacetate

Acute Toxicity: oral

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:

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

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

Test material information

Constituent 1

Reference substance name:

Sodium mercaptoacetate

EC Number:

206-696-4

EC Name:

Sodium mercaptoacetate

Cas Number:

367-51-1

Molecular formula:

C2H4O2S.Na

IUPAC Name:

sodium sulfanylacetate

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 or test system 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:

water

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

Key result

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:

other: 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 ho

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:

Category 3 based on GHS criteria

Conclusions:

The median lethal dose is between 50 and 200 mg/kg in rat after a single oral administration in both sexes.