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Diss Factsheets

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

No hematological, hepatic, or renal effects or changes in body weight were observed in study in Sprague-Dawley rats exposed to 3.6 chromium(III)/kg/day as chromium chloride in drinking water for 1  year. The No-observed-adverse-effect level (NOAEL) for systemic effect of chromium chloride is considered to be 3.6 mg Cr(III)/kg/day as chromium chloride.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summarized in a well-known publication
Qualifier:
no guideline available
Principles of method if other than guideline:
Sprague-Dawley rats were exposed to 3.6 mg chromium(III)/kg/day as chromium trichloride in drinking water for 1 years.
GLP compliance:
not specified
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Route of administration:
oral: drinking water
Vehicle:
not specified
Details on exposure:
Sprague-Dawley rats were exposed to 3.6 mg chromium(III)/kg/day as chromium trichloride in drinking water for 1 years.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
1 year
Frequency of treatment:
once daily
Post exposure period:
n/a
Remarks:
Doses / Concentrations:
25 ppm chromium chloride/kg/day (equal to 3.6 mg chromium(III)/kg/day)
Basis:
nominal in water
No. of animals per sex per dose:
N/A
Control animals:
not specified
Observations and examinations performed and frequency:
N/A
Sacrifice and pathology:
N/A
Details on results:
It was noted no change in body weight, macroscopic or microscopic pathology, or clinical chemistry variables.
Relevance of carcinogenic effects / potential:
No hematological, hepatic, or renal effects or changes in body weight were observed in study in Sprague-Dawley rats exposed to 3.6 chromium(III)/kg/day as chromium chloride in drinking water for 1 year.
Dose descriptor:
NOAEL
Effect level:
3.6 mg/kg bw/day (nominal)
Based on:
element
Remarks:
chromium(III)
Sex:
male/female
Basis for effect level:
other: It was noted no change in body weight, macroscopic or microscopic pathology, or clinical chemistry variables at a concentration of 3.6 mg Cr(III)/kg/day.
Remarks on result:
other: Effect type: toxicity (migrated information)
Conclusions:
No-observed-adverse-effect level (NOAEL) for systemic effect of chromium chloride is considered to be 3.6 mg Cr(III)/kg/day as chromium chloride.
Executive summary:

The report was evaluated against data from a drinking water study in which rats were exposed to drinking water concentrations of Cr(III)Cl3 at a concentration of 3.6 mg chromium(III)/kg bw/day as chromium chloride for a period of 1 year, which did not result in significant alterations in body weight gain. Chronic oral exposure to chromium(III) compounds did not result in any target organ toxicity in animals. It was noted no change in body weight, macroscopic or microscopic pathology, or clinical chemistry variables. The study suggested a no-observed-adversed-effect level (NOAEL ) at 3.6 mg trivalent chromium/kg bw/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
16.5 mg/kg bw/day
Study duration:
chronic
Species:
rat

Justification for classification or non-classification

Based on one read-across study, no indication is given for carcinogenicity of chromium(III) compounds such as chromium trinitrate and thus the substance is not classified for carcinogenicity according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC).

Additional information

The report was evaluated against data from a drinking water study in which rats were exposed to drinking water concentrations of CrCl3 at a concentration of 3.6 mg chromium(III)/kg bw/day as chromium chloride for a period of 1 year, which did not result in significant alterations in body weight gain. Chronic oral exposure to chromium(III) compounds did not result in any target organ toxicity in animals. It was noted no change in body weight, macroscopic or microscopic pathology, or clinical chemistry variables. The study suggested a no-observed-adverse-effect level (NOAEL ) at 3.6 mg trivalent chromium/kg bw/day, equivalent to 16.5 mg chromium trinitrate/kg bw/d.