Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: Literature reviews
Adequacy of study:
weight of evidence
Study period:
Variable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The three literature reviews report critical studies in summary form.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Health risk assessment report for metallic chromium and trivalent chromium
Author:
Finnish Institute of Occupational Health
Year:
2006
Bibliographic source:
Published by the International Chromium Development Association
Reference Type:
review article or handbook
Title:
Toxicological profile for chromium
Author:
Agency for Toxic Substances and Disease Registry
Year:
2000
Bibliographic source:
US Dept of Health and Human Services, Public Health Service, ATSDR
Reference Type:
review article or handbook
Title:
The toxicity of chromium and inorganic chromium compounds
Author:
Health and Safety Executive
Year:
1989
Bibliographic source:
HSE Toxicity review 21

Materials and methods

Type of sensitisation studied:
respiratory
skin
Study type:
other: various studies are reported
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Various studies are reported in these published literature reviews
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
The reviews contain studies of sensitisation performed with chromium (III) compounds

Method

Controls:
See below
Route of administration:
dermal

Results and discussion

Any other information on results incl. tables

According to the human maximization test, "chromium trioxide" was a moderate sensitizer; 13 of 23 humans were sensitized. There was some uncertainty about the identity of the substance (FIOH review, 2006). A number of clinical reports of foot and hand eczema in patients with chromium sensitivity have been associated with chrome tanned leather, where basic chromium (III) sulphate is often used. These cases may concern induction or elicitation, due to leaching of low levels of hexavalent or higher levels of trivalent chromium from the leather. There is no evidence that chromium (III) oxide dusts could cause respiratory sensitisation or asthmatic reactions (FIOH review, 2006).

Only 1% showed a positive response when sensitive individuals were patch tested with 33 ug chromium/cm2, and was negative upon re-testing (ATSDR review, 2000). Asthma developed in a man who had been well until one week after beginning employment as an electroplater (exposure to hexavalent chromium). When challenged with an inhalation exposure to a sample of chromium (III) sulphate, a water-soluble compound, he developed coughing, wheezing, and decreased forced expiratory volume. He also had a strong asthmatic reaction to nickle sulphate (ATSDR review, 2000; HSE review, 1989).

Approximately 50% of test subjects gave a positive response to topical challenge with chromium (III) sulphate using the human maximisation test (HSE review, 1989). Patients believed to have been sensitized to hexavalent chromium also gave positive skin reactions to topically applied Cr (III) in the form of water-soluble compounds chromium chloride, nitrate, acetate, sulphate or potassium sulfate, although high concentrations were required (HSE review, 1989).

Applicant's summary and conclusion

Conclusions:
Insoluble chromium (III) oxide has not demonstrated skin sensitizing potential or respiratory sensitization.
Executive summary:

The potency of trivalent chromium to sensitize is clearly much lower than hexavalent chromium. Soluble trivalent chromium compounds may have the potential to cause skin sensitization if they reach the critical dermal site of action in sufficient amounts. No documented cases of sensitization by insoluble chromium (III) compounds have been reported, most likely due to poor penetration of these compounds through human skin.