Calcium sulphidoacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-Mar-2012 - 28-Aug-2012

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium sulphidoacetate

EC Number:

249-881-5

EC Name:

Calcium sulphidoacetate

Cas Number:

29820-13-1

Molecular formula:

C2H4O2S.Ca x 3 H2O

IUPAC Name:

calcium 2-sulfanidylacetate

Constituent 2

Reference substance name:

CaTG

IUPAC Name:

CaTG

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: white powder
- Analytical purity: 99.8%
- Lot/batch No.: 3334
- Storage condition of test material: at room temperature, protected from humidity and under nitrogen gas.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: 290 ± 7 g for the males and 228 ± 6 g for the females
- Water and food: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 to 70
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG400

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): 1.64 mL/kg
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

A single dose of 2000 mg/kg of the test item in its original form was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of PEG 400) and then applied to the clipped area of the skin.

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 389 mg/kg bw

Based on:

act. ingr.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Because the test item in contact with purified water had a pH of 12. Criteria used for interpretation of results: expert judgment

Conclusions:

Under the experimental conditions, the dermal LD50 of CaTG is higher than 2000 mg/kg in rats.

Executive summary:

The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females).

The application was performed with the test item in its original form at the dose-level of 2000 mg/kg. PEG 400 was used to moisten the gauze pad and ensure a good contact with the skin.

The test site was then covered by a semi-occlusive dressing for 24 hours.

Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item.

All animals were subjected to necropsy.

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

A reduced body weight gain or a slight body weight loss was seen in 2/5 females between day 8 and day 15. The overall body weight gain of the other animals was similar to that of CIT historical control animals.

Skin reactions were noted in almost all animals between day 3 and day 14 at the latest.

No apparent abnormalities were observed at necropsy in any animal.