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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read-across from constituent CrIII
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Studies on contact sensitivity to chromium in the guinea pig. The role of valence in the formation of the antigenic determinant.
Author:
Siegenthaler U, Laine A, Polak L
Year:
1983
Bibliographic source:
Journal of Investigative Dermatology 80 (1):44-47

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing data

Test material

Reference
Name:
Unnamed
Details on test material:
CrCl3.6H2O or CrCl3

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: chromium chloride (Merck, Darmstadt, FRG)
Sex:
male/female
Details on test animals and environmental conditions:
T hey weighed about 350- 400 g when sensitization was begun. The animals were bred at the Institute for Biochemical Research, Fii Uinsdorf, Switzerland. T hey were fed on peUet d iet supplemented
ad libitum with water containing vitamin C.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
2 mg chromium chloride/l
Challenge
No.:
#1
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
2 mg chromium chloride/l
No. of animals per dose:
10
Details on study design:
The sensit ization was done in the following manner: 5 injections of 0.2 ml each of emulsion containing 2 mg/ml of chromium chloride (Merck, Darmstadt, FRG) in FCA were given into the footpad and nape of the neck.
Animals were restimulated once a week by an intradermal injection of 25/-1g chromium chloride in 0.1 ml 0.15 M NaCl solu tion into the skin of the right fl ank. S imultaneously 0.02 ml of 0.5% chromium chloride solution in 1 % Triton X-100 were applied epicutaneously on the skin of the left flank. The boosting was continued weekly until a positive reaction to the hapten was observed. The animals were then challenged epicutaneously with both haptens and the skin inflammation evaluated 24 hr later according to an arbitrary scale: red, swollen = 2, red, contluent = 1, red spots = 0.5.
Challenge controls:
not applicable
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2 mg/L
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
Seven out of 10 guinea-pigs sensitized and boosted with chromium chloride responded to an epicutaneous challenge with chromium chloride.
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
According to the results of the study, chromium trichloride can be considered to be a sensitizer to guinea pigs' skin.
Executive summary:

10 guinea pigs were exposed to 5 injections of 0.2 ml each of an emulsion containing either 2 mg chromium chloride/ml in Freund’s complete adjuvant (FCA) into the footpad and nape of the neck. The animals were restimulated once a week by intradermal injections of 25 µg of chromium trichloride. Simultaneously, 0.02 ml of 0.5% chromium trichloride in 1% Triton X-100 was applied epicutaneously to the skin of the opposite flank. The boosting was continued weekly until a positive reaction was observed. Four to six weeks after the positive skin reaction had emerged, the animals were challenged epicutaneously with both haptens, and skin inflammation was evaluated 24 h later. Seven out of 10 guinea-pigs sensitized and boosted with chromium trichloride responded to an epicutaneous challenge with chromium trichloride.