Aluminium, compound with nickel (1:1)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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.

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%

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.

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.

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.

Key result

Reading:

other: all

Group:

test chemical

Remarks on result:

no indication of skin sensitisation

Body weight changes were not remarkable.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:

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.

Justification for selection of skin sensitisation endpoint:

RL1