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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:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Part of research into potential skin sensitisation of different metal salts
Performed by non-LLNA assay using guinea pigs and mice

Data source

Reference
Reference Type:
publication
Title:
Evaluation of skin sensitization potential of nickel, chromium, titanium and zirconium salts using guinea-pigs and mice
Author:
Ikarashi Y, Momma J, Tsuchiya T, Nakamura A.
Year:
1996
Bibliographic source:
Biomaterials. 1996 Nov;17(21):2103-8.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Maximised method used using injection of solutions
Principles of method if other than guideline:
In addition to the maximised guinea pig work, a derivation of lymph node assay was performed with mice, but not following standard methods.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Historical research

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Not specified

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
1%
Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
Route:
other: Not specified
Vehicle:
water
Concentration / amount:
0.5%
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified
Positive control substance(s):
no

Results and discussion

Positive control results:
some of the tested materials resulted in positive responses

In vivo (non-LLNA)

Results
Reading:
other: Not specified
Group:
test group
Dose level:
1% induction, 0.5% challenge
No. with + reactions:
0
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Guinea-pigs were sensitised with NiSO4, K2Cr2O7 and TiCl4.

ZrCl4 did not cause any sensitisation response under these experimental conditions.

A sensitive mouse lymph node assay also determined NiSO4 and K2Cr2O7 as a sensitisers. In the SLNA, TiCl4 caused mild lymph node responses, but was classified as a non-sensitizer as well as ZrCl4.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although the methods are not well-described, the research demonstrarted the potential sensitisation os some metal salts and showed absence of sensitisation by zirconium salts
Sulphates are not considred sensitisingin their own right, so this research on the soluble chloride is considered a valid substitute