Chromium trichloride

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:

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

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

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

Albino guinea pigs weighing 300 and 500 Gm.

Route:

other: subcutaneous

Vehicle:

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

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

Route:

intradermal

Vehicle:

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

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

Positive control results:

N/A

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..

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

There were three studies available to evaluate the sensitization potential of chromium trichloride (CrCl3)

Gross PR, Sidney A, Katz SA, Samitz MD (1968) exposed the 13 guinea-pigs to 0.5 mL of FCA with 0.5 ml of 3.4 × 10E−2 mol chromium chloride hexahydrate/L by three subcutaneous injections in the nape 1 week apart. 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.

Only one original article is available, which has been selected as a robust study summary, other two studies are summarized in a well-known publication (International Programme on Chemical Safety (IPCS) 2009). Both of them (Siegenthaler et al. and Polak et al.) revealed positive reactions to chromium trichloride in guinea pigs, supporting the finding of Gross et al. above.

Based on the description given in these reports, chromium trichloride can be considered to be a sensitizer to guinea pigs' skin.

Migrated from Short description of key information:
Weight of evidence from three independent research groups investigating skin sensitisation reactions caused by chromium trichloride shows, that this substance has to be considered a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
only one original article is available, other information was just summarized in the review publication.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available results described in peer reviewed publications, chromium trichloride can be classified as sub-category 1A for skin sensitisation according to CLP (Regulation EC No.1272/2008) respectively as a skin sensitizer Xi, R43 according to DSD (Directive 67/548/EEC).