Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-02-09 to 2010-05-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

12252-12-9

Cas Number:

12252-12-9

IUPAC Name:

12252-12-9

Constituent 2

Reference substance name:

Ettringite

IUPAC Name:

Ettringite

Details on test material:

- Name of test material (as cited in study report): Casul-Pulver getrocknet (Ettringit)
- Molecular formula: Ca6[Al(OH)6]2(SO4)3.26H2O
- Substance type: white suspension
- Physical state: liquid/solid
- Lot/batch No.: R-Cl050609pH7
- Expiration date of the lot/batch: 2010-12-25
- Stability under test conditions: stable
- Storage condition of test material: room temperature
formulation of Casul-Pulver getrocknet (Ettringit) in water, 100 g/l, neutralized with sulfuric acid to pH7.0, which resulted in a content of dry mass of 102 g/l.

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders, D-88353 Kißlegg, Germany
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 324 -404 g
- Housing: groupwise
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

unchanged (no vehicle)

Induction 2

Concentration / amount:

100 %

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Challenge 2

Concentration / amount:

100 %

No. of animals per dose:

10

Details on study design:

RANGE FINDING TESTS:one animal tested with intradermal concentration of 0, 1, 2,5 and 5 %.4 animals tested with 24h occlusive dermal application of 0.5 ml of 0, 25, 50 and 100 % test item formulation.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 , first intradermal and second dermal exposure
- Exposure period: dermal exposure period: 48 h
- Test groups:1
- Control group:1
- Site: dorsal region and the flanks
- Frequency of applications: topical induction one week after the intradermal induction
- Duration: 3 weeks after the dermal induction
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Test groups:1
- Control group:1
- Site: doral region and flankx
- Concentrations: 100%
- Evaluation (hr after challenge): no later than 21

OTHER:

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

0.5 ml 100%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 ml 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Executive summary:

After a pilot study with 5 animals the Guinea Pig Maximization Test (GPMT) was performed in 2010 on 15 female guinea pigs (10 animals for the test item group and 5 control animals) to determine whether the test item Casul-Pulver getrocknet (Etteringit) exhibits skin-sensitising properties. Additional 2 animals were used for dose-finding for the challenge concentration. Intradermal induction: 5%. topical induction: 100%, challenge: 100%. The test item was formulated in sterile 0.9% NaCl-solution.

The challenge led to no skin effect and the animals showed no clinical signs. Under the conditions of this test the test item is not sensitising.