Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of Sodiumbis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodium [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) and Sodiumbis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-)
EC number: 915-756-5 | CAS number: -
- 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:
- 8.64 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 432 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 4
- Justification:
- A conservative extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 24.5 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:
- 350 mg/kg bw/day
- Value:
- 4 900 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure available. Taken into account the physico-chemical properties of the substance, dermal absorption is anticipated to be 10 % of oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 4
- Justification:
- An extrapolation factor for exposure duration is used: subacute screening (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- low hazard (no threshold derived)
Additional information - workers
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2012). Regarding the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered each to a value of 1, and are not shown in the calculations presented below.
Acute, systemic DNEL
Short term DNELs are not required as the acute toxicity of the test substance is low. The test substance is not classified and labeled for acute systemic toxicity, according to Regulation 1272/2008/EC (CLP), based on the test data for acute oral and dermal toxicity. Acute short term inhalation toxicity is also regarded as low due to the physico-chemical properties of the test substance (assumed vapor pressure < 10-6 hPa, melting point not available, decompses at 260 °C).
Acute/long-term, local
The test substance is classified and labeled as irritating to the eyes (category 2, H319). Therefore, a qualitative approach for hazard assessment is deemed necessary. The test substance is further considered as sensitizing based on available data (category 1B, H317).
Long term, systemic DNEL
Occupational exposure to the test substance occurs mainly by dermal route, and may also occur by inhalation exposure. Therefore two long-term DNELs are calculated for workers.
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
In order to derive a long-term inhalation DNEL, an inhalation NOEC was derived from NOEL oral value (determined in a reproductive/developmental screening study according to OECD Guideline 422), as no repeated dose inhalation study was available. Oral NO(A)EL of 350 mg/kg bw/day was converted to an inhalation NO(A)EC, assuming 100 % absorption via the lung and 50 % absorption via the oral route.
Step 2: Modification into a correct starting point:
The oral NO(A)EL was converted into an inhalation NO(A)EC according to the following formula assuming a daily exposure period of 8 hours during light activity:
Relevant dose descriptor (NO(A)EL): 350 mg/kg bw/day
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Frequency of exposure in study: 7 days/week
Frequency of worker exposure: 5 days/week
Corrected inhalatory NOAEC for workers
= 350 mg/kg bw/day × (1 / 0.38 m³/kg bw/day) × 0.5 × (6.7 m³/10 m³) x (7/5)
= 432 mg/m³
Step 3: Use of assessment factors: 50
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Exposure duration AF: 4
In conclusion, long term systemic inhalation DNEL, workers = 8.64 mg/m³
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
In order to derive a long-term dermal DNEL, a dermal NOEL was derived from NOEL oral value (determined in a 59-d repeated dose toxicity study with female rats), as no repeated dose dermal study was available. The oral NO(A)EL of 350 mg/kg bw/day was used as starting point.
Step 2: Modification into a correct starting point:
Correction for dermal absorption rates of the test substance (based on Guidance on information requirements and chemical safety assessment, R. 7C, 2014, Chapter R 7.12):
Dermal absorption is supposed to be low regarding the molecular weight of 689.5 g/mol and the moderate water solubility. The barrier function of the skin for ionic substances further decreases the penetration of the test substance. In addition, the results of the acute dermal toxicity support a low absorption via dermal route. Therefore, oral NO(A)EL of 350 mg/kg bw/day was converted to a dermal NO(A)EL, considering a conservative 10 % absorption through the skin.
Frequency of exposure in study: 7 days/week
Frequency of worker exposure: 5 days/week
In conclusion, dermal NO(A)EL = 350 x (100/10) x (7/5)= 4900 mg/kg bw/d.
Step 3: Use of assessment factors: 200
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (worker): 5
Exposure duration AF: 4
In conclusion, long term systemic dermal DNEL, workers = 24.5 mg/kg bw/day.
References
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.
- ECHA (2014). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.52 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Value:
- 152.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 4
- Justification:
- An extrapolation factor for exposure duration is used: subacute screening (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 8.75 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Value:
- 3 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. Taken into account the physico-chemical properties of the substance, dermal absoption is anticipated to be 10 % of oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 4
- Justification:
- An extrapolation factor for exposure duration is used: subacute screenin (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.875 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 350 mg/kg bw/day
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is required since a repeated dose oral toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 4
- Justification:
- An extrapolation factor for exposure duration is used: subacute screening (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2012). Regarding the data used for evaluation, the "quality of whole database factors" and "dose-response factors" are considered each to a value of 1 and are not shown in the calculations presented below.
Acute, systemic DNEL
Short term DNELs are not required as the acute toxicity of the test substance is low. The test substance is not classified and labeled for acute systemic toxicity, according to Regulation 1272/2008/EC (CLP), based on the test data for acute oral and dermal toxicity. Acute short term inhalation toxicity is also regarded as low due to the physico-chemical properties of the test substance (assumed vapor pressure < 10-6 hPa, melting point not available, decompses at 260 °C).
Acute/long-term, local
The test substance is classified and labeled as irritating to eyes (category 2). Therefore, a qualitative approach for hazard assessment is deemed necessary. The test substance is further considered as sensitizing based on available data (category 1B, H317).
Long term, systemic DNEL
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
In order to derive a long-term inhalation DNEL, an inhalation NOEC was derived from NOEL oral value (determined in a reproductive/developmental screening study according to OECD 422), as no repeated dose inhalation study was available. Oral NO(A)EL of 350 mg/kg bw/day was converted to an inhalation NOEC, assuming 100 % absorption via the lung and 50 % absorption via the oral route.
Step 2: Modification into a correct starting point:
Relevant dose descriptor (NO(A)EL): 350 mg/kg bw/day
Standard respiratory volume of the rat (sRVrat) for 8 hours: 1.15 m³/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Corrected inhalatory NOAEC for general population
= 350 mg/kg bw/day × (1 / 1.15 m³/kg bw/day) × 0.5
= 152.2 mg/m³
Step 3: Use of assessment factors: 100
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 4
In conclusion, long term systemic inhalation DNEL, general population = 1.52 mg/m³
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
In order to derive a long-term dermal DNEL, a dermal NOEL was derived from NOEL oral value (determined in a reproductive/developmental screening study according to OECD 422), as no repeated dose dermal study was available. The oral NO(A)EL of 350 mg/kg bw/day was used as starting point.
Step 2: Modification into a correct starting point:
Correction for dermal absorption rates of the test substance (based on Guidance on information requirements and chemical safety assessment, R. 7C, 2014, Chapter R 7.12):
Dermal absorption is supposed to be low regarding the molecular weight of 689.5 g/mol and the moderate water solubility. The barrier function of the skin for ionic substances further decreases the penetration of the test substance. In addition, the results of the acute dermal toxicity support a low absorption via dermal route. Therefore, oral NOEL of 1000 mg/kg bw/day was converted to a dermal NOEL, considering a conservative 10 % absorption through the skin.
In conclusion, dermal NO(A)EL = 350 x (100/10) = 3500 mg/kg bw/d.
Step 3: Use of assessment factors: 400
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 4
In conclusion, long term systemic dermal DNEL, general population = 8.75 mg/kg bw/day.
Oral exposure
Step 1: Selection of the relevant dose descriptor (starting point):
In order to derive a long-term oral DNEL, an oral NO(A)EL determined in the 59-d repeated dose toxicity study with female rats was identified as the relevant dose descriptor (350 mg/kg bw/day).
Step 2: Use of assessment factors: 400
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 2.5
Intraspecies AF (general population): 10
Exposure duration AF: 4
In conclusion, long term systemic oral DNEL, general population = 0.875 mg/kg bw/day.
References
- ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.
- ECHA (2014). Guidance on information requirements and chemical safety assessment. Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics.
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.