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A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate
EC number: 402-850-1 | CAS number: - NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
- 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:
- 1.64 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 123 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL (No Observed Adverse Effect Level) on females for general toxicity by oral route obtained in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route) was selected as the most representative starting dose based on: exposure route, study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 8h- breathing volume of rat (0.38 m3/kg bw), 8h- breathing volume of human general population (6.7 m3), 8 h- workers (10 m3) and correction for differences between human and experimental exposure conditions (7 d /5 d). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC inh for worker = 100 mg/kg bw/d / (0.38 m3/kg bw) × (6.7 m3/10 m3(8h)) × (7 d /5 d) × 0.5
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for NAEC derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling has been already considered in starting point derivation
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.467 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL (No Observed Adverse Effect Level) on females for general toxicity by oral route obtained in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route) was selected as the most representative starting dose based on: exposure route, study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: the correction for differences between human and experimental exposure conditions (7 d /5 d)
Based on the assumption that dermal absorption is not generally higher than oral absorption, no default factor for bioavailability should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (oral) used
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study performed on rat
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The DNELs (Derived No Effect Levels) for both inhalation and dermal long-term exposures related to systemic effects, are estimated starting from the NOAEL (No Observed Adverse Effect Level) for oral route. Specifically, the NOAEL considered is the one obtained on females for general toxicity by oral route determined in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route); it is selected as the most representative starting dose based on: exposure route, study duration, presence of adverse effects, parameters observed. Therefore, the calculation of NOAELinhalation, dermal should be done considering the differences between the experimental conditions and the real human exposure situation.
In order to accout the interspecies difference between rat and human, variability and uncertainty within and between species the NOAEL has to be corrected, using the appropriate assessment factors for DNEL calculation.
No DNEL is derived for inhalation acute exposure related to systemic effects, as, based on the physicochemical properties (i.e. negligible vapour pressure and inhalable fraction particle size) inhalation is not an appropriate route of exposure. Analogously, no DNEL via inhalation route is derived for either long-term or acute local effects because significant exposure is unlikely to occur. In addition, it should be noted that the applied RMM and OCs contribute to minimised the possibility of inhalation exposure.
No DNEL is derived for dermal acute exposure, systemic and local effects, because no acute toxicity potential and no skin irritation were observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion)
Since no substance-related local effects were observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion), only the DNEL for long-term dermal systemic effects is derived.
Regarding the hazard for eyes, the substance can be considered as medium hazardous, based on its potential to cause eye damage according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E: Risk Characterisation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL (No Observed Adverse Effect Level) for general toxicity by oral route obtained in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route) was selected as the most representative starting dose based on: expusure route, study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 24 h- breathing volume of rat (1.15 m3/kg bw) and 24 h- breathing volume of human general population (20 m3). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC inh for general public = 100 mg/kg bw/d / (1.15 m3/kg bw) × 0.5
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for NAEC derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling has been already considered in starting point derivation
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.167 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL (No Observed Adverse Effect Level) on females for general toxicity by oral route obtained in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route) was selected as the most representative starting dose based on: exposure route, study duration, presence of adverse effects, parameters observed.
Based on the assumption that dermal absorption is not generally higher than oral absorption, no default factor for bioavailability should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (oral) used
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study performed on rat
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.167 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The modification of dose description is not necessary, as NOAEL on females for general toxicity by oral route obtained in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route) was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats were used in the available test
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The DNELs (Derived No Effect Levels) for inhalation, dermal and oral long-term exposures related to systemic effects, are estimated starting from the NOAEL (No Observed Adverse Effect Level) for oral route. Specifically, the NOAEL considered is the one obtained on females for general toxicity by oral route determined in the Reproduction/Developmental Toxicity Screening Test (OECD 421, oral route); it is selected as the most representative starting dose based on: exposure route, study duration, presence of adverse effects, parameters observed.Therefore, the calculation of NOAELinhalation, dermal, oral should be done considering the differences between the experimental conditions and the real human exposure situation. In order to accout the interspecies difference between rat and human, variability and uncertainty within and between speciesthe NOAEL has to be corrected, using the appropriate assessment factors for DNEL calculation.
No DNEL is derived for inhalation acute exposure related to systemic effects, as, based on the physicochemical properties (i.e. negligible vapour pressure and inhalable fraction particle size) inhalation is not an appropriate route of exposure. Analogously, no DNEL via inhalation route is derived for either long-term or acute local effects because significant exposure is unlikely to occur. In addition, it should be noted that the applied RMM and OCs contribute to minimised the possibility of inhalation exposure.
No DNEL is derived for dermal acute exposure, systemic and local effects, because no acute toxicity potential and no skin irritation were observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion)
Since no substance-related local effects were observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion), only the DNEL for long-term dermal systemic effects is derived.
No DNEL is derived for oral exposure because no acute toxicity potential was observed up to 5000 mg/kg bw in the acute oral toxicity study
Regarding the hazard for eyes, the substance can be considered as medium hazardous, based on its potential to cause eye damage according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E: Risk Characterisation.
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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