Aluminium sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliable without restrictions. Well-presented study, with relevant measurement of chemical concentrations

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)

Principles of method if other than guideline:

Method remark:
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.
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.

GLP compliance:

yes

Remarks:

(Test No. BO2112)

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: Calcium sulfate, dihydrate
- Molecular formula (if other than submission substance): CaSO4•2H2O
- Molecular weight (if other than submission substance): 172.171
- Smiles notation (if other than submission substance): O.O.[O-]S(=O)(=O)[O-].[Ca+2]
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Density -2.32 g/cm3)
- Solubility in water - 2.05 g/L at 20 °C
- Synonyms: Alabaster
Annaline
C.I. Pigment white 25
Gypsum
Gypsum stone
Land and plaster
Light spar
Magnesia white
Mineral white
Native calcium sulfate
Precipitated calcium sulfate
Sainite
Satin spar
Sulfuric acid, calcium(2+) salt, dihydrate
Terra alba
- Calcium sulfate, dihydrate consists of colorless, monoclinic and hygroscopic crystals

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test condition : Test organism
- Age: 3 to 4 months old
- Number of animals: 3 animals
- Sex: Males weighting 2.1 kg ~ 2.4 kg
Total dose: 500 mg/site/rabbit of calcium sulfate, dihydrate
Vehicle: Not used
Route of administration: With an occluded patch
Exposure time period: 4 hours
Scoring method used: OECD method (Grading of skin reaction)

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

none

Controls:

yes

Amount / concentration applied:

Concentration: 500 mg

Duration of treatment / exposure:

4 hour(s)

Observation period:

72 hours.

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.
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.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 (hrs)

Score:

0

Max. score:

0

Reversibility:

other: No erythema

Remarks on result:

other: No erythema

Results 2

Irritation parameter:

other: Oedema

Basis:

mean

Time point:

other: 1, 24, 48, 72, (hrs)

Score:

0

Max. score:

0

Reversibility:

other: No oedema

Remarks on result:

other: No oedema

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.

Other effects:

Weight loss was observed in 24 hours after the administration.
Body weight was almost recovered in 72 hours.

Any other information on results incl. tables

The skin on the backs of three rabbits appeared unaffected.

- 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.
Weight loss was observed in 24 hours after the administration. 
Body weight was almost recovered in 72 hours.


Evaluation of skin irritation
Right site: Calcium sulfate, dihydrate

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


Erythema 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


Right site: Calcium sulfate, dihydrate
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 definite 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 did not make skin irritation at the test concentration
- 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.
Weight loss was observed in 24 hours after the administration.
Body weight was almost recovered in 72 hours