Registration Dossier
Registration Dossier
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EC number: 234-439-6 | CAS number: 12003-78-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt-, Wasserwirtschaft und Gewerbeaufsicht, Rheinland-Pfalz
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was already carried out before the entry into force of the admendments to Annex VII.
Test material
- Reference substance name:
- Aluminium, compound with nickel (1:1)
- EC Number:
- 234-439-6
- EC Name:
- Aluminium, compound with nickel (1:1)
- Cas Number:
- 12003-78-0
- Molecular formula:
- Al.Ni
- IUPAC Name:
- aluminum - nickel (1:1)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identity Aluminium compound with nickel (RANEY® 2813)
Label name RANEY 2813
CAS number 12003-78-0
Batch no. 1401
Expiry date 01 August 2018
Storage conditions Ambient temperature in a dessicator
RTC number 14684
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Weight range at arrival: 259 to 268 grams
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period
Animals per cage: Up to 5
Housing: Noryl cages measuring 74.354.325 cm
Cage control: Daily inspected and changed as necessary (at least 3 times/week)
Water: Drinking water supplied to each cage via a water bottle
Water supply: Ad libitum
Diet 8GP17 (Mucedola S.r.l., Via G. Galilei, 4, 20019, SettimoMilanese (MI) Italy))
Diet supply: Ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 25 air changes per hour
Temperature range: 22 °C +/- 2 °C
Relative humidity range: 55% +/- 15%
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 50, 20, 10, 5, 1 and 0.5%
Concentration of 50% w/v was found not administrable and concentrations of 20, 10 and 5% were administered with difficulty.
Challenge
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 50, 20, 10, 5, 1 and 0.5%
Concentration of 50% w/v was found not administrable and concentrations of 20, 10 and 5% were administered with difficulty.
- No. of animals per dose:
- 10
- Details on study design:
- The study was divided into 2 distinct phases. The first of these was a dose-ranging screen which was used to determine suitable dose levels for use in the second phase. This second phase corresponded to the main study: determination of the sensitisation potential of the test item.
- Challenge controls:
- No response to the test item at a concentration of 50% in corn oil was observed in either test or control group animals, 24 and 48 hours following a 24 hour topical exposure period. No reaction to the vehicle alone was observed.
- Positive control substance(s):
- yes
- Remarks:
- No response to the test item at a concentration of 50% in corn oil was observed in either test or control group animals, 24 and 48 hours following a 24 hour topical exposure period. No reaction to the vehicle alone was observed.
Results and discussion
- Positive control results:
- Sensitisation reactions were observed in 100% of the animals in the reliability check. These results are considered to be acceptable for a weak sensitiser like alpha-Hexylcinnamaldehyde.
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: all
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Body weight changes were not remarkable.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- These results indicate that the test item, Aluminium compound with nickel (RANEY® 2813), does not elicit a skin sensitisation response in the guinea pig, no reaction being observed at challenge.
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