Chromium trichloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well described and documented publication with appropriate methodology used although prior to guideline publication

Data source

Reference

Reference Type:

publication

Title:

Sensitization of guinea pigs to chromium salts.

Author:

Gross PR, Sidney A, Katz SA, Samitz MD

Year:

1968

Bibliographic source:

Journal of investigative Dermatology, 50:424–427.

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: similar to OECD406 but with intradermal challenge phase

Deviations:

not specified

Principles of method if other than guideline:

The study followed the design of maximization test in guinea pigs but in the challenge phase intradermal injections were used - thus the skin barrier was circumvented in this test design.

GLP compliance:

no

Type of study:

intracutaneous test

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

Molecular formula:

Cl3Cr

IUPAC Name:

chromium trichloride

Test material form:

not specified

Details on test material:

reported as chromic chloride

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Albino guinea pigs weighing 300 and 500 Gm.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

other: subcutaneous

Vehicle:

other: 0.5 cc of complete Freund's adjuvans and 0.5 cc of 3.4 10E-2 molar CrCl3

Induction 2

Concentration / amount:

the sensitizing injections contained 0.5 cc of Freund's complete adjuvant with 0.5 cc of 3.4 × 10E-2 M CrCl3. The test dose was 0.1 cc of 4.2 × 10E-4 M CrCl3 in physiologic saline intradermally

Challenge

Challenge 1

Route:

intradermal

Vehicle:

other: 0.5 cc of complete Freund's adjuvans and 0.5 cc of 3.4 10E-2 molar CrCl3

Challenge 2

Concentration / amount:

the sensitizing injections contained 0.5 cc of Freund's complete adjuvant with 0.5 cc of 3.4 × 10E-2 M CrCl3. The test dose was 0.1 cc of 4.2 × 10E-4 M CrCl3 in physiologic saline intradermally

No. of animals per dose:

13: chromium chloride;
30: control group

Details on study design:

Thirteen guinea-pigs were given chromium trichloride hexahydrate by three subcutaneous injections in the nape 1 week apart. The sensitizing injections contained 0.5 ml of FCA with 0.5 ml of 3.4 × 10E−2 mol chromium chloride hexahydrate/L. Three weeks later, the animals were tested with an intradermal injection into clipped or epilated skin. The eliciting dose was 0.1 mL of 4.2 × 10E−4 mol chromium chloride hexahydrate/L.

Challenge controls:

N/A

Positive control substance(s):

not specified

Results and discussion

Positive control results:

N/A

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

4.2 × 10−4 mol

No. with + reactions:

10

Total no. in group:

13

Clinical observations:

developed positive reactions (at least grade +) ; of these, four were read as ( grade +2). None developed (grade +3) or (grade +4) reactions.

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 4.2 × 10−4 mol . No with. + reactions: 10.0. Total no. in groups: 13.0. Clinical observations: developed positive reactions (at least grade +) ; of these, four were read as ( grade +2). None developed (grade +3) or (grade +4) reactions..

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results, chromium trichloride hexahydrate is a sensitizer to guinea pigs' skin at the 3.4 × 10E−2 M under the conditions of this report.

Executive summary:

Thirteen guinea-pigs were given chromium trichloride hexahydrate by three subcutaneous injections in the nape 1 week apart. The sensitizing injections contained 0.5 ml of FCA with 0.5 ml of 3.4 × 10E−2 mol chromium chloride hexahydrate/L. Three weeks later, the animals were tested with an intradermal injection into clipped or epilated skin. The eliciting dose was 0.1 mL of 4.2 × 10E-4 mol chromium chloride hexahydrate/L. After 48 h, this produced moderate positive responses in 10 of the 13 animals, whereas the control animals (injected only with FCA) showed no reactions. However, this test design is rather extreme as it circumvented the skin barrier not only in the induction phase but also during the challenge phase.