Registration Dossier
Registration Dossier
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EC number: 215-607-8 | CAS number: 1333-82-0
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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