Registration Dossier
Registration Dossier
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EC number: 213-909-4 | CAS number: 1066-30-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 106 mg/m³
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic --> chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 097 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 13 718 mg/m³
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.141 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- other: NAEC
- AF for dose response relationship:
- 3
- Justification:
- LAEC -- > NAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic --> chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 38
- Dose descriptor starting point:
- other: NAEC
- AF for dose response relationship:
- 3
- Justification:
- LAEC -- > NAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 015 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic --> chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 015 mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- other: NOAEL
- AF for intraspecies differences:
- 5
- Justification:
- intrahuman AF
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The DNEL for acute dermal effects is based on the subchronic feeding study. Dermal absorption is believed to be as low as gastrointestinal absorption (1%). For systemic effects, an assessment factor (AF) of 50 is composed of 2.5 (toxicodynamic interspecies AF), 4.0 (allometric scaling, rat) and 5 (intraspecies AFs, worker). For local effects on skin, only the intraspecies AF of 5 remains applicable.
The DNEL for acute inhalation effects is based on the subchronic inhalation study study. The typical acute inhalation study comprises an exposure duration of 4 h. In the subchronic study, exposure duration was 6 h/day on a total of 65 days, i.e., a total of 6×65 hours (390 h).
For relatively insoluble dusts like Cr(III) sulphate, the toxicity is correlated with the total lung burden. The NOAEC for systemic effects is ≥ 210 mg/m³. Applying Haber’s “c×t” rule, one can estimate that a systemic 4-h NOAEC in the rat could be 390 / 4 × 210 = 20,475 mg/m³.
This value needs to be corrected for a higher respiratory activity of workers (6.7/10) giving a corrected human 4-h NAEC of 13,718 mg/m³. Likewise, the LOAEC for local lung effects is converted into a human 4-h LAEC of 1372 mg/m³. The AF for local effects is derived by applying a toxicodynamic AF of 2.5, an intrahuman AF of 5, and an additional AF of 3 for extrapolation from an LOAEC to an NOAEC. This gives a total AF of 37.5. For systemic effects, the extra AF of 3 is not needed (clear NOAEC), yielding a remaining AF of 12.5.
The DNEL for skin irritation is based on the skin irritation study. The applied dose is 500 mg/ 6 cm² and represents the NOAEL for Cr picolinate, since the substance is not irritating to skin. Read across to the lower MW of basic Cr(III) acetate monohydrate, the NOAEL is 40 mg/cm². An AF of 5 for intraspecies variability applies.
A DNEL for skin sensitisation cannot be derived since an EC3 could not be determined from the LLNA data (EC3<10%).
A long-term DNEL for systemic effects following dermal exposure is derived by route-to-route extrapolation from a subchronic feeding study. The interspecies AF is 10 for a rat study, the AF for workers is 5 and an extra AF of 2 is applied for extrapolation from subchronic NOAEL to chronic exposure (total AF=100). A local DNEL cannot be proposed because of the skin-sensitizing properties for basic Cr(III) acetate.
The subchronic inhalation LOAEC/NOAEC (local/systemic) are corrected for 8-h exposure (6/8) and for higher respiratory activity (6.7/10) to give an 8-h human local LAEC/ systemic NAEC of 10.6/106 mg/m³. The AF for local effects is derived by applying a toxicodynamic AF of 2.5, an intrahuman AF of 5, and additional AFs of 3 and 2 for extrapolation from LOAEC to NOAEC and for subchronic-to-chronic extrapolation, respectively. This gives a total AF of 75. For systemic effects, the extra AF of 3 is not needed (clearly defined NOAEC), yielding a remaining AF of 25. The DNEL pertains to the alveolar dust fraction.
The existing OEL (Directive 2006/15/EC) for Cr(III) compounds (2 mg Cr/m³, total dust) is equivalent to 8 mg basic Cr(III) acetate monohydrate/m³ (total dust).
The OEL should remain the relevant limit value for total dust, whereas the inhalation DNEL should be used as an upper limit for the alveolar dust fraction.
The supported use of basic Cr(III) acetate is within solid matrices. Exposure of the general population can thus be precluded; DNELs for the general population are not relevant.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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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