Chromium potassium bis(sulphate)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

As with all inorganic salts, the significance for toxicity or environmental assessment, is the presence of specific ions that will form when in solution or when in biological systems.In the case of Cr III salts, the counter ion will have an effect on solubility and this is itself dependant on the type of media being used and in particular the pH of that media. It is generally accepted that in the case of metal salts, testing with salts that are soluble in the respective test media will ensure maximum exposure of the metal ions. This will include chlorides and nitrates as being more soluble and will indeed have relevance when dissolved in acid media, such as if ingested.Read-across to other chromium III salts is therefore considered valid as long as the exposure in the test system is greater than would be expected for the substance under review for registration.

Data source

Reference

Reference Type:

publication

Title:

SENSITIZATION OF GUINEA PIGS TO CHROMIUM SALTS

Author:

PAUL R. GROSS, SIDNEY A. KATZ, M.H. SAMITZ

Year:

1968

Bibliographic source:

THE JOURNAL OF INVESTIGATIVE DERMATOLOGY - VOL. 50 424-427

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

THE PURPOSE OF THE METHODS WAS TO EXAMINE CROSS SENSITISATION BETWEEN Cr(VI) to Cr(III). THE TEST METHOD WAS MODIFIED TO PROVIDE A CONSISTENTLY SUCCESSFUL LEVEL OF SENSITIZATION.

GLP compliance:

no

Remarks:

BEFORE GLP

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

EXISTING DATA, FURTHER ANIMAL STUDIES NOT JUSTIFIED

Test material

Test material information

Constituent 1

Reference substance name:

Chromium trichloride

EC Number:

233-038-3

EC Name:

Chromium trichloride

Cas Number:

10025-73-7

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Albino guinea pig

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: Freud's complete adjuvant

Concentration / amount:

0,5 cc of 3,4e-2M CrCl3

Challenge

Route:

intradermal

Vehicle:

other: Freund's complete adjuvant

Concentration / amount:

0,1 cc of 4.2e+4M Cr Cl3

No. of animals per dose:

30

Details on study design:

Guinea pigs were sensitised by administering three subcutaneous injections of an emulsion containing 0.5 cc Freund's complete adjucant and 0,5 cc 3.4 x 10-2 M CrCl3 into the nape one week apart. Three weeks later, the animals were tested with intradermal injections in clipped or epilated skin. The eliciting dose was 4.2 x 10-4 M CrCl3. Animals sensitised with CrCl3 were also tested with a number of additional trivalent salts, and to conjugates of chromium linked with plasma proteins and skin extract proteins. The concentrations were determined as being the lowest concentrations causing positive effects with Chrome VI compounds.

Challenge controls:

The challenge dose produced no reaction in 30 control animals.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

66 mg/l

No. with + reactions:

0

Total no. in group:

30

Clinical observations:

No adverse effects

Remarks on result:

no indication of skin sensitisation

Results 2

Group:

negative control

Remarks on result:

not determinable because of methodological limitations

Results 3

Group:

positive control

Remarks on result:

not determinable because of methodological limitations

Applicant's summary and conclusion

Interpretation of results:

other: See the publication attached