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EC number: 303-757-8 | CAS number: 94213-53-3
- 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:
- 0.263 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:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 18.375 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No infromation on Direct Violet 051 is vailable in order to derive DNEL value. For this reason data on Similar Substance 01 have been taken into account.
No long-term exposure data is available for the inhalation route, therefore, the NOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The NOAEL value was calculated to be 15 mg/kg bw/day, as at the higher dose (40 mg/kg bw) toxic effects were observed on testes.
To calculate the DNEL it is necessary first to calculate the NAECworkers, inhalation applying the following formula:
NAECworkers, inhalation= NOAELrat, oral÷ 4 × 70 kg ÷ 10 m3× 1.4 × 0.5 = 15 mg/kg bw/day ÷ 4 × 70 kg ÷ 10 m3× 1.4 × 0.5 = 18.375 mg/m3
As the NOAEL value was particular to rats, an assessment factor of 4 was considered for interspecies differences; the standard body weight considered for workers is 70 kg, therefore, the NOAEL is multiplied by a factor of 70 kg. A worker is considered to be exposed to 10 m3 for 8 hours per day for 5 days out of 7, therefore, the NOAEL value is multiplied by 10 m3 and a factor of 1.4 to account for weekends.
Finally, absorption of a substance by the inhalation route is considered to be 100 % once it reaches the alveolar level, whereas absorption via the oral route is considered generically to be 50 %, therefore, the NOAEL value is multiplied by 0.5 to account for absorption differences.
The DNELworkers was then calculated as follows:
DNELworkers, inhalation = NAECworkers,inhalation/Overall AF = 18.375 mg/m3 / 75 = 0.2625 mg/m3
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (63-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences are already considered in the original formula (above), whereby the NOAEL was multiplied by a factor of 4 to allow for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 210 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No information on Direct Violet 051 is vailable in order to derive DNEL value. For this reason data on Similar Substance 01 have been taken into account.
No long-term exposure data is available for the inhalation route, therefore, the NOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The NOAEL value was calculated to be 15 mg/kg bw/day, as at the higher dose (40 mg/kg bw) toxic effects were observed on testes.
To calculate the DNEL it is necessary first to calculate the NAECworkers, dermal applying the following formula:
NOAELworkers, dermal= NOAELrat, oral x 1.4/0.1 = 15 mg/kg bw/day × 1.4/0.1 = 210 mg/kg bw
A worker is considered to be exposed to a substance for 5 days out of 7, therefore, the NOAEL value is multiplied by a factor of 1.4.
A default value of 100 % skin absorption is allocated to substances with a molar mass below 500 and a partition coefficient between log Pow-1 and 4. In the case of Direct Violet 051 the molecular mass and/or partition coefficient values are outside the given range, therefore a skin absorption value of 10 % is allocated.
The DNELworkers, dermal was then calculated as follows:
DNELworkers, dermal= NOAECworkers,dermal/Overall AF = 210 mg/kg bw/ 300 = 0.7 mg/kg bw
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (63-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.037 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:
- 15 mg/m³
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 5.625 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No information on Direct Violet 051 is available in order to derive DNEL value. For this reason data on Similar Substance 01 have been taken into account.
No long-term exposure data is available for the inhalation route, therefore, the NOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The NOAEL value was calculated to be 15 mg/kg bw/day, as at the higher dose (40 mg/kg bw) toxic effects were observed on testes.
To calculate the DNEL it is necessary first to calculate the NAEChuman, inhalation applying the following formula:
NAEChuman, inhalation= NOAELrat, oral÷ 4 × 60 kg ÷ 20 m3× 0.5 = 15 mg/kg bw/day ÷ 4 × 60 kg ÷ 20 m3× 0.5 = 5.625 mg/m3
As the NOAEL value was particular to rats,an assessment factor of 4 was considered for interspecies differences; the standard body weight considered for the general population is 60 kg, therefore, the NOAEL is multiplied by a factor of 60 kg. A person is considered to be exposed to 20 m3 for 24 hours per day for 7 days a week, therefore, the NOAEL value is multiplied by 20 m3. Finally, absorption of a substance by the inhalation route is considered to be 100 % once it reaches the alveolar level, whereas absorption via the oral route is considered generically to be 50 %, therefore, the NOAEL value is multiplied by 0.5 to account for absorption differences.
The DNELhumans was then calculated as follows:
DNELhumans, inhalation= NAEChumans,inhalation/Overall AF = 5.625 mg/m3/ 150 = 0.0375 mg/m3
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (63-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences are already considered in the original formula (above), whereby the NOAEL was multiplied by a factor of 4 to allow for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population such as age, health, race
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard quality data base
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEL dermal
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No information on Direct Violet 051 is available in order to derive DNEL value. For this reason data on Similar Substance 01 have been taken into account.
No long-term exposure data is available for the inhalation route, therefore, the NOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The NOAEL value was calculated to be 15 mg/kg bw/day, as at the higher dose (40 mg/kg bw) toxic effects were observed on testes.
To calculate the DNEL it is necessary first to calculate the NOAELhuman, dermal applying the following formula:
NOAELhuman, dermal= NOAELrat, oral/ 0.1 = 15 mg/kg bw/day / 0.1 = 150 mg/kg bw
A default value of 100 % skin absorption is allocated to substances with a molar mass below 500 and a partition coefficient between log Pow-1 and 4. In the case of Direct Violet 051 the molecular mass and/or partition coefficient values are outside the given range, therefore a skin absorption value of 10 % is allocated.
The DNELhumans, dermalwas then calculated as follows:
DNELhumans, dermal= NOAEChumans,dermal/Overall AF = 150 mg/kg bw/ 600 = 0.25 mg/kg bw
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (63-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 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:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No information on Direct Violet 051 is vailable in order to derive DNEL value. For this reason data on Similar Substance 01 have been taken into account.
No long-term exposure data is available for the inhalation route, therefore, the NOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The NOAEL value is considered 15 mg/kg bw/day.
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (63-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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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