Ammonium mercaptoacetate

Acute Toxicity: oral

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:

1996

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:

Ammonium mercaptoacetate

EC Number:

226-540-9

EC Name:

Ammonium mercaptoacetate

Cas Number:

5421-46-5

Molecular formula:

C2H4O2S.H3N

IUPAC Name:

ammonium 2-sulfanylacetate

Details on test material:

Test substance: Ammonium Thioglycolate 71%
Aqueous solution of ammonium thioglycolate.
Batch number: B96S1805
Content of active ingredient: 71%
Source: Bruno Bock Chemische Fabrik GmbH & Co KG

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Source: Fa. Harlan Winkelmann GmbH, 33178 Borchen
Acclimatization period: 15-21 days
Weight range at study initiation: 260-282 g (m), 189-206 g (f)
Fasting: 16 hours before dosing and 3-4 hours after dosing

Husbandry:
Housing: collective housing up to a maximum of 3 animals per cage (Makrolon type III)Illumination: artificial lighting from 7.00 a.m.-7.00 p.m.
Temperature: 22±3 °C
Relative humidity: 30-70%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The acute oral toxicity of "Ammonium thioglycolate 71 %" was investigated according to a stepwise procedure in Wistar rats.
Three animals of one sex are used for each step.

On the basis of toxicity data from the test substance, a starting group of 3 female rats received a single oral administration of "Ammonium thioglycolate 71 %" in a dose of 200 mg/kg body weight. Based on the stepwise procedure, further groups using 3 females and 3 males each were treated with doses of 25 and 50 mg/kg body weight, respectively.

Doses:

25, 50, 200 mg/kg of the 71% ammonium thioglycolate solution

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Clinical observations were conducted at regular intervals during the 14-day observation period.
Gross pathological examinations were performed immediately on animals found dead and at termination on day 14 on surviving animals.
Body weights were measured at days 0, 7 and 14.

Statistics:

not appropriate

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 - < 200 mg/kg bw

Based on:

test mat.

Remarks:

71% solution

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 35 - < 142 mg/kg bw

Based on:

act. ingr.

Mortality:

All 3 female rats treated with 200 mg/kg body weight died pre-terminally. All animals of the other dose groups survived the whole observation period of 14 days.

Clinical signs:

other: All 3 rats treated with 200 mg/kg body weight showed severe clinical symptoms appearing 2 h post-administration and leading to death. All 3 female rats which received 50 mg/kg body weight exhibited alopecia on day 14 post administration. No other clinical

Gross pathology:

Gross pathological examinations on day 14 post administration (terminal necropsy) revealed no test article-dependent findings in the lower dose groups of 25 and 50 mg/kg body weight. In all 3 female rats which received 200 mg/kg body weight and died spontaneously, test article-dependent findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The median acute lethal dose for rats of both sexes is 50 to 200 mg/kg bw for the 71% solution of Ammonium Thioglycolate. According to Table 3.1.2 of the CLP regulation, this range can be converted to a point estimate of 100 mg/kg bw.