Potassium mercaptoacetate

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:

Potassium mercaptoacetate

EC Number:

252-038-4

EC Name:

Potassium mercaptoacetate

Cas Number:

34452-51-2

Molecular formula:

C2H4O2S.K

IUPAC Name:

potassium sulfanylacetate

Test material form:

solid - liquid: suspension

Details on test material:

- content: 42.8% KTG in water
- specific gravity: 1.25 g/ml
- Lot/batch No.: 4678
- Storage condition of test material: at room temperature and under nitrogen gas.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- 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:

unchanged (no vehicle)

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 and then applied to the clipped area of the skin.

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female, which was accidentally wounded on the removal of the dressing, was killed on day 2 for ethical reasons. No deaths related to treatment 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

Conclusions:

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