Reaction mass of calcium sulfate and potassium sulfate and sodium sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance to GLP and guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

calcium sulfate, dihydrate

IUPAC Name:

calcium sulfate, dihydrate

Constituent 2

Reference substance name:

10101-41-4

EC Number:

600-148-1

Cas Number:

10101-41-4

IUPAC Name:

10101-41-4

Details on test material:

- Name of test material (as cited in study report): Calcium sulfate dihydrate
- Physical state: Solid (white powder)
- Analytical purity: 99.9%
- Lot/batch No.: Sigma Aldrich Corporation, Lot No. - 109H0166

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3~4 months
- Weight at study initiation: 2.1 ~ 2.4kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

water

Controls:

no

Amount / concentration applied:

500 mg test material in 0.1 mL of sterile distilled water

Duration of treatment / exposure:

4 h

Observation period:

The skin of animals was examined in accordance with an OECD scoring method for signs of erythema and oedema and the responses scored at 1, 24, 48 and 72 hours after the patches removal. Mortality, clinical signs and body weight were also observed.

Number of animals:

3

Details on study design:

500 mg of test material with about 0.1 mL of sterile distilled water for humidity was applied to the abraded and intact sites on the shaved backs (2.5 x 2.5 cm) of rabbits. It was held in place for 4 hours with three fold gauze patches, which was applied in place with elasticity bandage then was fixed with non-irritating tape (3M paper-tape) to prevent leakage. After 4 hours, three gauze patches were removed and the exposed areas were washed using warm water without altering the existing response or the integrity of the epidermis.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 24, 48, 72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 24, 48, 72 h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 24, 48, 72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1

Time point:

other: 24, 48, 72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 2

Time point:

other: 24, 48, 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 3

Time point:

other: 24, 48, 72 h

Score:

0

Irritant / corrosive response data:

Not irritating: no erythema, no eschar and no oedema was observed at the skin on the backs of three rabbits. - There were no clinical signs in relation to spread with calcium sulfate, dihydrate.

Any other information on results incl. tables

Table 1: Erythema and eschar irritation scores

Change	Erythema & Eschar
Applicated area	Intact				Abraded
Phase (hrs)	1	24	48	72	1	24	48	72
Animal ID	0	0	0	0	0	0	0	0
M01	0	0	0	0	0	0	0	0
M02	0	0	0	0	0	0	0	0
M03	0	0	0	0	0	0	0	0
Total	0	0	0	0	0	0	0	0
Mean	0	0	0	0	0	0	0	0
Total of mean	0

Erythma and Eschar formation

0 – No erythema

1 – Very slight erythema (barely perceptible)

2 – Well defined erythema

3 – Moderate to severe erythema

4 – Severe erythema (beef redness) to eschar formation preventing grading of erythema

Table 2: Oedema irritation scores

Change	Oedema
Applicated area	Intact				Abraded
Phase (hrs)	1	24	48	72	1	24	48	72
Animal ID	0	0	0	0	0	0	0	0
M01	0	0	0	0	0	0	0	0
M02	0	0	0	0	0	0	0	0
M03	0	0	0	0	0	0	0	0
Total	0	0	0	0	0	0	0	0
Mean	0	0	0	0	0	0	0	0
Total of mean	0

Oedema formation

0 – No oedema

1 – Very slight oedema (barely perceptible)

2 – Slight oedema (edges of area well defined by definitive raising)

3 – Moderate oedema (raised approximately 1 mm)

4 – Severe oedema (raised more than 1 mm and extending beyond area of exposure)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Calcium sulfate dihydrate was not considered to be irritating to skin