Diammonium 2,2'-dithiodiacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

EC 92/69/EEC (1992-07-31)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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

Test material form:

other: aqueous solution 48%w/w diammonium 2,2'-dithiodiacetate

Details on test material:

Lot# 4883
assay iodometric: 48.1% w/w

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

ten animals (5 male, 5 female) age appr. 9 weeks mean body weight 308+-8 (male), 226+-11 (female)
Acclimation 5 days before study start
Environmental condition:
- 22+-2 °C
- 30 - 70% rel. humidity
- 12/12 h light dark cycle
- ventilation: 12 cycles/h of filtered non recycled air
records of conditiones were checked daily. Instrument calibration at regular intervals.

During acclimation animals were house one to seven animals of same sex in polycarbonate cages with stainless steel lid.
During treatment period animals were housed individually in PC cages of 35.5x23.5x19.3 dimension, on autoclaved sawdust (SICSA, Alfortville France)
Food and Water: All animals had free access to pelleted diet (A04C, SAFE, Villemoisson, Epinay-sur-Orge, France) and Water filtered by FG Millipore membrane 0.22µ ad libitum.

In Life date: 12 to 26 of march 2003

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: a dorsal area of the skin (approximately 5 cm x 6 cm for the females and 5 cm x 7 cm for the males)
- % coverage: approximately 10%
- Type of wrap if used: hydrophilic gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.6 mL/kg
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

2000 mg/kg of the 48% solution (960 mg/kg active ingredient)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The animals were observed frequently during the hours following administration of the test itemfor detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15.
From day 2, any local cutaneous reaction was recorded.
The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
The body weight gain of the treated animals was compared to that of CIT control animals with a similar initial body weight.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic necropsy examination:All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main morgans (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. Preservation of tissues: No organ samples were taken.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 960 mg/kg bw

Any other information on results incl. tables

No clinical signs and no deaths were observed during the study.

A reduced body weight gain was observer in 2 mals and 2 females in da 1 to 8 and one male in day 8 to 15. The other anaimals were not affected in comparison to historical control animals.

No cutaneous reactions were observed.

No apparent abnormalities were observed at necroscopy of any animals.

The LD0 is higher than 2000 mg/kg of a 48% aqueous solution of the test material (equivalent to 960 mg/kg of active ingredient)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No effects could be observed up to the highest test concentration (2000 mg/kg). Therefore, the LD0 is determined to be >2000 mg/kg. According to the classification criteria (Dir 67/548/EC)GHS criteria the test item should not be classified.