Reaction mass of chromium (+ 3) hydroxide sulfate and sodium sulfate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

other: Review

Adequacy of study:

weight of evidence

Study period:

Variable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Critical studies reported in summary form.

Data source

Reference

Reference 1

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 2

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 3

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

Study type:

clinical case study

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Oral, dermal and intravenous administration of water-soluble chromium (III) compounds to volunteers were reviewed. Inhalation exposure of workers to soluble and insoluble chromium (III) compounds was summarized in the reviews.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Chromium hydroxide sulphate

EC Number:

235-595-8

EC Name:

Chromium hydroxide sulphate

Cas Number:

12336-95-7

Molecular formula:

CrHO5S

IUPAC Name:

chromium hydroxide sulphate

Constituent 2

Reference substance name:

not applicable

IUPAC Name:

not applicable

Details on test material:

Inhalation study in West German factories: Atmospheric monitoring at the time of the study indicated mean concentrations of 0.5-2 mg Cr (III)/m3 as chromium oxide and 0-0.5 mg Cr (III)/m3 as chromium sulphate.

Method

Type of population:

occupational

other: human volunteers

Subjects:

Oral, dermal and intravenous studies: Healthy adult volunteers

Inhalation studies: Examination of workers in factories producing chromium (III) sulphate and chromium (III) oxide, as well as tannery workers exposed mainly to water-soluble chromium (III) compounds.

Route of exposure:

dermal

inhalation

oral

other: intravenous injection

Reason of exposure:

other:

Exposure assessment:

measured

Details on exposure:

Inhalation study in two West German factories: Over half the workers had more than 10 years of employment in the factories.

Results and discussion

Any other information on results incl. tables

Oral exposure: Highly water-soluble chromium (III) chloride was poorly absorbed from the gastrointestinal tract following oral administration to human volunteers: only 0.2 -0.7% of the dose appeared in the urine in 24 -72 hours (HSE, 1989). The mean absorption of chromium was 2.8% + 1.4% as determined in 8 healthy adults administered 400 ug Cr (III)/day as chromium picolinate for 3 consecutive days (ATSDR, 2000). An acute, oral dose of radioactive chromium chloride was administered to humans after which feces and urine were collected for 24 hours. The amount of chromium (III) in the 6 -day fecal collection was 99.6% of the dose and 0.5% of the dose was present in the 24 -hour urine collection (FIOH, 2006).

Dermal exposure: No measurable penetration of chromium through the skin, and no increase in blood or urine chromium, was observed 24 hours following application of water-soluble chromium (III) chloride or sulphate to the skin of human volunteers. High levels of chromium in the blood, urine and internal organs were reported in a man accidentally immersed in hot, acidic chromium (III) sulphate solution, although this reflects passage of Cr (III) through severely damaged skin (HSE, 1989). An experiment in which a researcher dipped one hand in tanning solution containing 7 g/L Cr as basic chromium sulphate for 1 hour did not result in any measurable percutaneous absorption of chromium (FIOH, 2006). One case report of chromium dermatitis and poisoning claimed to be due to skin absorption of a 35 -year old male in India who had worked for ten years in a tannery, 9 years in the vegetable tanning section and one year in the chrome tanning section. He treated hides with basic chromium sulphate and the solution was said to spill onto both legs up to about 10 cm above each ankle. The authors suggested that the patient had, after development of chronic dermatitis, absorbed toxic amounts of chromium resulting in anaemia as well as liver and kidney affection. It has been suggested that the patient was sensitized to chromium and exhibited contact dermatitis in both legs above the ankles (FIOH, 2006).

Intravenous injection: Two studies have followed the fate of 'physiological doses' (0.5 -1 ug) ⁵¹Cr (III), injected intravenously as chromium chloride into human volunteers. All of the blood radioactivity remained in the plasma, at least 90% being bound to plasma proteins. Seventy-five percent of the Cr (III) was cleared from the blood in seven days and 25% of the dose appeared in the urine in 24 hours. Whole body autoradiography scanning at 2 days indicated that most of the ⁵¹Cr (III) was located in the liver, spleen, adipose and muscle tissue, and bone, with radioactivity clearly present in the liver at 3 months (HSE, 1989).

Inhalation exposure: There was no evidence of skin or respiratory problems, or of unusual haematology or clinical chemistry after repeated exposure of 106 West German factory workers to chromium sulphate as summarized in the HSE review (1989). No stomach or liver disorders and no increase in prevalence of respiratory illness were found in another study of 128 workers from two factories that produced chromium sulfate or chromium oxide (ATSDR, 2000). Tannery workers had higher urinary chromium (III) concentrations in postshift urine samples taken Friday afternoon and in preshift urine samples taken Monday, compared to controls. These workers also had hair concentrations of chromium that correlated with urinary levels. Analysis of workroom air revealed 0.0017 mg Cr (III)/m³ time-weighted average and no detectable chromium (VI) (ATSDR, 2000). In another study, elimination of chromium (III) from hair, serum and urine was studied in 5 men who had ceased working in a leather tannery 9 months earlier. The mean levels of chromium in hair and serum were reduced from 28.5 to 2.9 umol/g and from 9.4 to 3.8 nmol/L, respectively. Urine levels were unchanged but the authors attributed this to consumption of beer the night before sampling (FIOH, 2006). Exposure to chromium among six employees of a leather factory was studied and the two hide press operators were found to have high levels of chromium in their blood and urine whereas the four hide receivers showed concentrations at the limit of detection (FIOH, 2006).

Applicant's summary and conclusion

Conclusions:

There is no good evidence of adverse health effects arising from occupational exposure to water-soluble chromium (III) compounds, although there is limited published data available.

Executive summary:

According to studies summarized in three literature reviews, water-soluble chromium (III) species are poorly absorbed from the GI tract and have variable capacity to penetrate into the skin, although there is no evidence of systemic absorption if the protective epidermis is intact. Workers exposed to water-soluble chromium (III) compounds via inhalation show elevated blood and urine chromium levels but long-term elevation of chromium concentrations in the body does not seem to occur.