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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Carc. 1A (route via inhalation), Acute Tox. 2 (H330: fatal if inhaled) hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Carc. 1A (route via inhalation), Acute Tox. 2 (H330: fatal if inhaled) hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.38 µg/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):
300
Dose descriptor starting point:
LOAEL
Value:
1.7 mg/m³
Modified dose descriptor starting point:
LOAEL
Value:
2.38 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic LOAEL of 1.7 mg (Cr (VI)/kg bw/day was determined in an oral 90 day repeated dose toxicity studyin rats (NTP, 2007a). This value was converted into the corrected dermal NOAEL taking into account the the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4. No correction for absorption rates is needed as the absorption rates for the dermal and oral route are the same (10 %).

LOAEC corrected = 1.7 mg/kg bw/day * 1.4 = 2.38 mg/kg bw/day

AF for dose response relationship:
3
Justification:
Default for starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Acute Tox. 2 (H331: fatal in contact with skin) hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

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:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Carc. 1A (route via inhalation), Acute Tox. 2 (H330: fatal if inhaled), hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Carc. 1A (route via inhalation), Acute Tox. 2 (H330: fatal if inhaled), hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.83 µg/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):
600
Dose descriptor starting point:
LOAEL
Value:
1.7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
1.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic LOAEL of 1.7 mg mg (Cr VI)/kg bw/day was determined in an oral 90 day repeated dose toxicity study in rats (NTP, 2007a).

No correction for absorption rates is needed as the absorption rates for the dermal and oral route are the same (10 %).

AF for dose response relationship:
3
Justification:
Default for starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
default for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information
Explanation for the modification of the dose descriptor starting point:

As the substance is classified as Acute Tox. 2 (H331: fatal in contact with skin), hazard assessment conclusion is set to high hazard according to ECHA’s Guidance Part E (v3, May 2016).

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:
2.83 µg/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):
600
Dose descriptor starting point:
LOAEL
Value:
1.7 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
1.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A LOAEL of 1.7 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in mice (NTP, 2007a). This value does not have to be corrected, as the oral absorption rates in human and rat are considered to be identical.

AF for dose response relationship:
3
Justification:
Starting point is a LOAEL
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rat
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.49 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

In accordance with ECHA Guidance R.8 the long-term DNEL derived based on an oral sub-chronic study in rats (NTP, 2007a) is modified by multiplying with a factor of 3 to derive the acute DNEL.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population