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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.61 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
32.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOEL(chronic) of 18.5 mg CrCl3.6H2O/kg bw/d is converted to a NOAEC by dividing by 0.38 and multiplying by 0.67 according to ECHA Guidance (NOAEC of 32.6 mg CrCl3.6H2O/m3). No absorption correction is applied as inhalation absorption and oral absorption are considered both low (10% as worst case assumption).
AF for dose response relationship:
1
Justification:
NOAEC is used as a starting point
AF for differences in duration of exposure:
1
Justification:
based on a chronic study (MacKenzie, 1958)
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
for workers the default factor of 5 is used
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used, supported by data from a subchronic study
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.61 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.31 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
LOAEC
AF for dose response relationship:
1
Justification:
not required as LOAEC based on minimal local, reversible effects
AF for differences in duration of exposure:
2
Justification:
based on a subchronic inhalation study
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.62 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
LOAEC
AF for dose response relationship:
1
Justification:
not required as LOAEC based on minimal local, reversible effects
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default factor for worker
AF for the quality of the whole database:
1
Justification:
not required
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.37 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
other: NOEL
Value:
18.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral to dermal, no adjustment for absorption made as both, dermal and oral absorption, are considered max. 10%
AF for dose response relationship:
1
Justification:
NOEL is used as a starting point.
AF for differences in duration of exposure:
1
Justification:
based on a chronic study (MacKenzie, 1958)
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used in the animal test
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used, supported by subchronic data
AF for remaining uncertainties:
1
Justification:
no other uncertainties needed to be considered.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.37 mg/kg bw/day
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

For systemic effects the most reliable study to derive a NO(A)EL for DNEL derivation is the 1-year chronic toxicity study by oral route (Mackenzie, 1958). In this study one dose of 25 ppm in drinking water (equivalent to 3.6 mg Cr/kg bw/d or 18.5 mg CrCl3.6H2O/kg bw/d) was applied to rats and no systemic or local effects were noted. Thus, the highest dose 18.5 mg CrCl3.6H2O/kg bw/d can be seen as NOEL. Anderson (1997) found a NOAEL of 7 mg Cr/kg bw/d in a subchronic oral feeding study, pointing into the same direction. Accordingly, the NOEL from the 1-year chronic toxicity study of 18.5 mg CrCl3.6H2O/kg bw/d, derived by MacKenzie (1958) is used as basis for derivation of DNELs for systemic effects.

For local effects by inhalation exposure, the results found in a 90 day-inhalation study (Derelanko et al., 1999) has shown slight and reversible local effects in the respiratory tract when chromium hydroxyl sulphate was applied as dust. Chromium hydroxyl sulphate is acidic and very soluble in water same as chromium trichloride. Therefore, results from this study are suitable for read across and the study may be used to derive the DNEL(inhalation) for local effects towards chromium(III) species such as chromium trichloride. Consequently, the LOAEC of 3 mg Cr(III) /m3 in this study was used to derive inhalation DNELs for local effects (long term and acute exposure). As no systemic effects were seen in this study and thus no NOAEL for systemic effects was derived, the DNELs for systemic effects were based on the chronic oral studies (see above).

For dermal exposure, no suitable data are available and thus the oral chronic data were used for route to route extrapolation to assess dermal systemic DNELs.

In the absence of skin irritation seen for chromium trichloride but a potential for skin sensitization, short term DNELs were not derived but a high hazard is assumed, leading into a qualitative exposure and risk assessment, targeting at minimization of skin exposure.

No eye irritation / damage was seen in in vitro and in vivo studies for chromium trichloride and thus no hazard to eyes is concluded.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.644 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
16.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOEL(chronic) of 18.5 mg CrCl3.6H2O/kg bw/d is converted to a NOAEC by dividing by 1.15 according to ECHA Guidance (NOAEC of 16.1 mg CrCl3.6H2O/m3). No absorption correction is applied as inhalation absorption and oral absorption are considered both low (10% as worst case assumption).
AF for dose response relationship:
1
Justification:
NOAEC is used as a starting point
AF for differences in duration of exposure:
1
Justification:
based on a chronic study (MacKenzie, 1958)
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used, supported by data from a subchronic study
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.644 mg/m³
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.077 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
LOAEC
AF for dose response relationship:
1
Justification:
not required as LOAEC based on minimal local effects
AF for differences in duration of exposure:
2
Justification:
based on a subchronic inhalation study
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.154 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
LOAEC
AF for dose response relationship:
1
Justification:
not required as LOAEC based on minimal local effects
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into account

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.185 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
18.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
oral to dermal, no adjustment for absorption made as both, dermal and oral absorption, are considered max. 10%
AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
1
Justification:
based on a chronic study (MacKenzie, 1958)
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used in the animal test
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used, supported by subchronic data
AF for remaining uncertainties:
1
Justification:
no other uncertainties need to be considered.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.185 mg/kg bw/day
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.185 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
18.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route to route extrapolation applied
AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
1
Justification:
based on a chronic study result (MacKenzie, 1958)
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used in the animal test
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used, supported by subchronic data
AF for remaining uncertainties:
1
Justification:
no other uncertainties need to be considered.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.185 mg/kg bw/day
DNEL related information
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Chromium trichloride is not used by the general population and thus no exposure is foreseeable. However, for sake of completeness, also DNELs for general population were derived and the same underlying data as used for deriving worker DNEL (see above) were used.