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Registration Dossier
Diss Factsheets
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EC number: 914-129-3 | CAS number: 12336-95-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 124.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 506 mg/kg bw/day elemental chromium was determined in an oral 90 day repeated dose toxicity study in rats (NTP, 2010). This NOAEL can be regarded as worst-case for the registered substance as it is based on elemental chromium. This study was selected as point of departure as in the available repeated dose inhalation study by Derelanko (1999) the local effects clearly prevail over the systemic effects. Therefore no reliable systemic NOAEC could be derived from this study.
The NOAEL of 506 mg/kg bw/day was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (oral 10 % and inhalation 100 % are assumed as worst-case assumptions - please refer to Section 7.1.) and the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 506 mg/kg bw/day * 1/0.38 m³/kg/day * 10%/100% * (6.7 m³/10 m³) * 1.4 = 124.9 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allomoetric scaling needed extrapolating oral-to-inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default, no route substance specific information on toxicokinetik and dynamic available
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 17 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 32.83 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The registered substance is acute toxic by the inhalation route. In an acute inhalation study according to OECD Test Guideline 403 and GLP male and female Han Wistar rats underwent a single 4 -hour nose only inhalation exposure to chromium hydroxide sulphate at a mean atmospheric exposure level of 4.58 mg/L. The test compound was poorly tolerated, causing persistent clinical signs. Seven out of ten animals died during the course of the study. The LC50 is therefore considered to be below 4580 mg/m³. As no actual LC50 value could be derived in this study and no information on sub-lethal effects can be derived from this study, it is not suitable to serve as dose-descriptor starting point for the systemic acute DNEL. In the repeated dose toxicity study by Derelanko et al. (1999) it was shown that the local effects clearly prevail over systemic effects in case of inhalative exposure. In this study a LOAEC of 17 mg/m³ was derived based on local effects on the respiratory tract. As no systemic effects were observed at this dose 17 mg/m³ could be considered as a systemic NOAEC. As this was derived from a chronic daily exposure, this is a clear worst-case assumption for the acute exposure. As in this study rats were exposed 6 h while the acute DNEL represents 15 min of exposure, this value is corrected for time using Haber's Law.
Haber's Law: Cn* t = k,
where ‘C’ is the concentration, ‘n’ is a regression coefficient, ‘t’ is the exposure time and ‘k’ is a constant; a default value of n=3 for extrapolating from longer to shorter exposure durations is used.
(C³ x t) = (C') ³ x t', giving C' = C x (t/t')0.333333. C' is the sought concentration. C' = 17 mg/m³ x (6h/0.25h)0.3333333= 49 mg/m³. The concentration of 49 mg/m³ was adjusted for the differences in the respiratory rates by normal conditions and by light activity: 0.67 (rest / light activity: 6.7 /10)
NOAEC corrected = 49 mg/m³ * 0.67 = 32.83 mg/m³
A total Assessment factor of 12.5 (5 for intra-species and 2.5 for remaining inter-species variability is applied to the corrected starting point of 32.8 mg/m³. The resulting DNEL is 2.6 mg/m³.
As this systemic acute DNEL based on a clear worst-case assumption is lower than the systemic long-term DNEL, the long-term DNEL, which is based on route-to-route extrapolation from a reliable long-term study is used also as short-term DNEL.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.11 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- LOAEC
- Value:
- 8.54 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEC to NOAC extrapolation
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not needed for local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- default for remaining interspecies differences
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.1 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 708 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 506 mg/kg bw/day elemental chromium was determined in an oral 90 day repeated dose toxicity study in rats (NTP, 2010). This NOAEL can be regarded as worst-case for the registered substance as it is based on elemental chromium.
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 %).
NOAEL corrected = 506 mg/kg bw/day * 1.4 = 708 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- 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:
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.88 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 506 mg/kg bw/day elemental chromium was determined in an oral 90 day repeated dose toxicity study in rats (NTP, 2010). This NOAEL can be regarded as worst-case for the registered substance as it is based on elemental chromium. This study was selected as point of departure as in the available inhalation study by Derelanko (1999) the local effects clearly prevail over the systemic effects. Therefore no reliable systemic NOAEC could be derived from this study.
This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day and the absorption rates (oral 10 % and inhalation 100 % are assumed as worst-case assumptions - please refer to Section 7.1.)
NOAEC corrected = 506 mg/kg bw/day * 1/1.15 m³/kg/day * 10%/100% = 44 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not needed for inhalation endpoint as already included in the corrected starting point
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.96 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 17 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 49 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The registered substance is acute toxic by the inhalation route. In an acute inhalation study according to OECD Test Guideline 403 and GLP male and female Han Wistar rats underwent a single 4 -hour nose only inhalation exposure to chromium hydroxide sulphate at a mean atmospheric exposure level of 4.58 mg/L. The test compound was poorly tolerated, causing persistent clinical signs. Seven out of ten animals died during the course of the study. The LC50 is therefore considered to be below 4580 mg/m³. As no actual LC50 value could be derived in this study and no information on sub-lethal effects can be derived from this study, the repeated dose toxicity study by Derelanko et al. (1999) is used to derive an acute systemic DNEL for the inhalation route. In this study a LOAEC of 17 mg/m³ was derived based on local effects on the respiratory tract. As no systemic effects were observed at this dose 17 mg/m³ is considered to be a systemic NOAEC. As this was derived from a chronic daily exposure, this is a clear worst-case assumption for the acute exposure. As in this study rats were exposed 6 h while the acute DNEL represents 15 min of exposure, this value is corrected for time using Haber's Law.
Haber's Law: Cn* t = k,
where ‘C’ is the concentration, ‘n’ is a regression coefficient, ‘t’ is the exposure time and ‘k’ is a constant; a default value of n=3 for extrapolating from longer to shorter exposure durations is used.
(C³ x t) = (C') ³ x t', giving C' = C x (t/t')0.333333. C' is the sought concentration. C' = 17 mg/m³ x (6h/0.25h)0.3333333= 49 mg/m³.
NOAEC corrected = 49 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- not needed as NOAEC was used as staring point
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not applicable for inhalation
- 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 database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.03 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor:
- LOAEC
- Value:
- 4.25 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEC to NOAC extrapolation
- AF for differences in duration of exposure:
- 2
- Justification:
- default for sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not needed for local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- default for remaining interspecies differences
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.09 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.53 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 506 mg/kg bw/day elemental chromium was determined in an oral 90 day repeated dose toxicity study in rats (NTP, 2010). This NOAEL can be regarded as worst-case for the registered substance as it is based on elemental chromium.
No correction for absorption rates is needed as the absorption rates for the dermal and oral route are the same (10 %).1.7
- AF for dose response relationship:
- 1
- Justification:
- Default
- 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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 2.53 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 506 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A systemic NOAEL of 506 mg/kg bw/day elemental chromium was determined in an oral 90 dayrepeated dose toxicity studyin rats (NTP, 2010). This NOAEL can be regarded as worst-case for the registered substance as it is based on elemental chromium.
This value does not have to be corrected as the oral absorption rate of rats and humans are considered to be identical (10 % as worst-case assumption).
- AF for dose response relationship:
- 1
- Justification:
- Default
- 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:
- 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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