Diammonium 2,2'-dithiodiacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999 - 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Dir. 96/54/EC

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diammonium 2,2'-dithiodiacetate

EC Number:

269-323-4

EC Name:

Diammonium 2,2'-dithiodiacetate

Cas Number:

68223-93-8

Molecular formula:

C4H6O4S2.2H3N

IUPAC Name:

diammonium 2-[(carboxymethyl)disulfanyl]acetate

Constituent 2

Reference substance name:

Diammonium 2,2’-dithiodiacetate

IUPAC Name:

Diammonium 2,2’-dithiodiacetate

Test material form:

other: liquid, aqueous solution

Details on test material:

Lot#: B99E3721
Assay: 48,0%w/w iodometric

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals: Sprague Dawley CD (Crl: (SD) IGS BR)
Source: Ch River (UK) Ltd, Margate Kent
Acclimatization period: 15-21 days
Weight range at study initiation:209-220 g (m), 202 - 236 g (f)
Acclimatisation at least 5 days
Fasting:overnight before dosing and 3-4 hours after dosing

Husbandry:
Housing: collective housing up to a maximum of 3 animals by sex per cage (Polypropylene)
Illumination: artificial lighting from 7.00 a.m.-7.00 p.m.
Temperature: 22±3 °C
Relative humidity: 30-70%
15 air changes / h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The acute oral toxicity of "Diammonium dithiodiglycolate 48 %" was investigated according to a stepwise procedure in Sprague-Dawley rats acc. OECD 423

Doses:

200, 500, 2000 mg/kg body weight

No. of animals per sex per dose:

200mg/ kg : 3/3
500 mg/kg : 3 f
2000 mg/kg: 3 f

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:

n.a.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 300 - < 500 mg/kg bw

Based on:

act. ingr.

Mortality:

Two animals treated with 2000 mg/kg and 500 mg/kg were found dead during the day of dosing. One anaimal treated with 2000 mg/ kg was killed in extremis during the day of dosing.
No deaths occured on 200 mg/kg dosing.

Clinical signs:

other: Individual observations are attached in the result tables in "background information" Common signs of toxicity noted at dose levels of 2000 mg/kg were hunched posture, decreased respiratory rate, and laboured respiration with incidents of ataxia, hypother

Gross pathology:

Individual necropsy findings are attached in the result tables in "background information" table 10 and 13

Abnormalities noted at necropsy of animals that died or the animal that was killed in extremis during the study were haemorrhagic or abnormally red lungs, dark liver, dark kidneys, haemorrhagic gastric mucosa and haemorrhagic small intestine. No abnormalitiees were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of the test material diammonium dithiodiglycolate 48% w/w in water in Sprague-Dawley rats was estimated to be in the range of 300 to 500 mg/kg body weight.
Mortalities were noted at 500 and 2000 mg/kg bodyweight.

The test material was classiefied as Acute tox. 4 according to the GHS criteria.

Executive summary:

The acute oral toxicity of the test material diammonium dithiodiglycolate 48% in water (diammonium 2,2'-dithiodiacetate) was evaluated accing OECD 423 (EU B.1) gueidelines.

All animals trates with 2000 mg/kg bodyweight died in the first day of observation. All animals treated with 200 mg/kg bodyweight survived with no clinical signs and normal gain of body weight.

2 Animals treated with 500 mG/kg bodyweight died. The surviving animal recovered three days after dosing with no clinical signs at the end of the study.

Stating a LD50 value of 300 to 500 mg/kg bodyweight the test material was classified as acute tox. 4