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EC number: 701-289-2 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
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:
- 2 010
- 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
- Reference substance name:
- dioxo-2,4-dioxa-1,5-dialumina-3-magnesapentane oxomagnesium alumane
- EC Number:
- 701-289-2
- Molecular formula:
- Al, MgO, Mg(AlO2)2
- IUPAC Name:
- dioxo-2,4-dioxa-1,5-dialumina-3-magnesapentane oxomagnesium alumane
- 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
Constituent 1
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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