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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:
From: 2010-03-02 To: 2010-03-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Skin was not treated with SLS prior to topical induction.
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Skin was not treated with SLS prior to topical induction.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
EC Number:
701-289-2
Molecular formula:
Al, MgO, Mg(AlO2)2
IUPAC Name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
Details on test material:
- Name of test material (as cited in study report): Aluminium-Skimmings
- Physical state: grey solid
- Analytical purity: Aluminium: 708.0 g/kg
Ammonium(NH4): 22.0 g/kg
Magnesium: 68.0 g/kg
- Lot/batch No.: Lieferung vom 21.04.2009
- Stability under test conditions: until August 21, 2011
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl: HA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders, 88353 Kißlegg, Germany.
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 332-402 g
- Housing: in groups of eight during the adaptation period and in groups of two or five per cage throughout the study period.
- Diet: "PROVIMI KLlBA 3420 - Maintenance Diet for Guinea Pigs", ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES: From: 2010-03-02 To: 2010-03-26

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
polyethylene glycol
Remarks:
400
Concentration / amount:
First induction: 76.9% (= 500 mg test item/animal)
Topical induction: 76.9% (= 500 mg test item/animal)
Challenge: 76.9% (= 500 mg test item/animal)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
polyethylene glycol
Remarks:
400
Concentration / amount:
First induction: 76.9% (= 500 mg test item/animal)
Topical induction: 76.9% (= 500 mg test item/animal)
Challenge: 76.9% (= 500 mg test item/animal)
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: yes with 76.9% paste on five animals

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Day of induction: d0 (intradermal), d7 (topical)
- Test groups: test substance in PEG 400
- Control group: PEG 400
- Site: dorso-cranial
- Duration: 48 h (topical)
- Concentrations: 76.9%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: d21
- Exposure period: 24 h
- Test groups: test substance in PEG 400
- Control group: test substance in PEG 400
- Site: right flank (caudal: test substance, cranial: vehicle)
- Concentrations: 76.9%
- Evaluation (hr after challenge): 48+72 h after start of application
Challenge controls:
Naive controls (5 animals), challenged with 76.9% test substance in PEG 400
Positive control substance(s):
yes
Remarks:
alpha-hexyl cinnamaldehyde

Results and discussion

Positive control results:
The Guinea Pig Maximization Test methodology was checked for reliability in a test on female guinea pigs using alpha hexyl cinnamic aldehyde formulated in polyethylene glycol 400 at the concentrations indicated below:
For the intradermal induction a 5% test item formulation was used, for the topical induction a 25% formulation and for the challenge a 12% formulation. After the challenge with the 12% test item formulation 100% of the test item animals exhibited dermal reactions in the challenge treatment. There was no reddening of the skin to be observed on control group animals.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
76.9%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 76.9%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
76.9%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 76.9%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
76.9%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 76.9%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
76.9%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 76.9%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information

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