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Toxicological information

Skin sensitisation

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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

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)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
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.