Calcium sulphidoacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04-Mar-2003 - 09-Mar-2003

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Test material

Test material information

Constituent 1

Reference substance name:

CaTG

IUPAC Name:

CaTG

Constituent 2

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: white powder
-The pH of the test item at the concentration of 10% in purified water, measured at CIT, was approximately 12.
- 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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.6 ± 0.2 kg.
- Food and water: ad libitum
- Acclimation: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- temperature: 18 ± 3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12 h/12 h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Doses of 500 mg of the test item were placed on a dry gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The gauze pad was used dry and not moistened with water because the pH of the test item in water is 12. The OECD Guideline No. 404 recommends to use water or another suitable vehicle (if necessary) to moisten the test item and ensure a good contact with the skin. However, as the skin of the rabbit may be sensitive to many vehicles, it was chosen not to use a moistening agent rather than a non well-tolerated vehicle (such as corn oil). Furthermore, this condition of application reflects more accurately the condition of a possible accidental exposure.

Duration of treatment / exposure:

As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals.

Observation period:

The skin was examined approximately 1, 24, 48 and 72 hour(s) after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: dryness of the skin on day 1 and 2

Results 2

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: dryness of the skin on day 1 and 2

Results 3

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: Day 7

Remarks on result:

other: Residual test item

Results 8

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: Day 7

Remarks on result:

other: Residual test item

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the test item CaTG is not irritating when applied topically to rabbits.

Executive summary:

After a 3-minute exposure (one animal), a very slight erythema (grade 1) was noted from day 1 up to day 4. Dryness of the skin was recorded on day 2 and 3 then between day 5 and day 10.

After a 4-hour exposure (three animals), a very slight or well-defined erythema (grade 1 or 2), together with a very slight oedema (grade 1) between day 2 and day 5, was noted in 1 of 3 animals from day 2 up to day 7. Dryness of the skin was recorded in the same animal from day 6 up to the end of the observation period (day 15).

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 2.0 for erythema and 0.0, 0.0 and 1.0 for oedema.