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Reaction mass of 5,5'-{(phenylmethanediyl)bis[benzene-4,1-diyl-diazene-2,1-diyl]}bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride and 5,5’-[3,4’-(phenylmethanediyl)diphenylene]bis(diazene-2,1-diyl)bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride
EC number: 700-312-3 | 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:
- 13.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance & ECETOC
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 793.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- As there is no inhalation study available an extrapolation using default assessment factors was performed. There was no information indicating other methods as more suitable.
- AF for dose response relationship:
- 1
- Justification:
- default, no information indicating otherwise is available
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolating subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for inhalation, ECHA Practical Guide 14, 2012
- AF for other interspecies differences:
- 1
- Justification:
- default, no information indicating otherwise is available
- AF for intraspecies differences:
- 5
- Justification:
- AF modified from Ecetoc TG 110 and German AGS 2006
- AF for the quality of the whole database:
- 1
- Justification:
- default, no information indicating otherwise is available
- AF for remaining uncertainties:
- 2
- Justification:
- ECHA Guidance, route to route extrapolation (oral to inhalation), conservative assumption
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report 110
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As worst case scenario it was assumed that the dermal bioavailability is equal to the oral bioavailability
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolating subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- adjusting metabolic rates rat to human
- AF for other interspecies differences:
- 1
- Justification:
- not required according to ECETOC technical report 110
- AF for intraspecies differences:
- 3
- Justification:
- according to ECETOC technical report 110
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General comment to DNEL derivation:
The DNELs derived for the substance registered, mostly have been derived based on studies read-across from the analogue substance (refer to IUCLID section 13). A full justification for appropriateness of the performed read-across approach is given as na appendix in chapter13, "Assessment Reports", of this dossier. The most relevant study for DNEL derivation is the oral subacute study on the source substance. Therefore, route-route extrapolation had to be applied for deriving certain DNELs. Derivation of inhalation DNEL is based on subacute oral study results. Derivation of assessment factors are based on ECETOC Technical Report 110 and ECHA Reach guidance. Modification was used according to German AGS 2010.
Systemic DNELs:
The long-term systemic inhalation DNELis considered to be sufficient to ensure that no effects occur. The starting point is the subacute study by oral gavage dosing in rats, resulting to a NOAEL of 450 mg/kg bw/day. This dose descriptor was corrected for route to route extrapolation in accordance with the procedure recommended in Chapter R8 of the REACH Technical Guidance documents (May 2008) as follows:
NOAEL oral rat (NOAELoral rat) = 450 mg/kg bw/day
Standard respiratory volume of a rat during 8 h exposure (SRvrat) =0.38 m3
Standard respiratory volume of a human during 8 h exposure (SRvhuman) = 6.7 m3/8hr
Standard respiratory volume of a human during light activity for a worker -8 h (WSRvhuman) =10 m3/8hr - light activity
NOECcorrfor workers = NOAELoral rat÷ SRvratx (SRvhuman÷ WSRvhuman)
Corrected NOEC = 450 mg/kg bw/day ÷ 0.38 m3/kg bw x (6.7 m3÷ 10 m3)
Corrected NOEC = 793.4 mg/m3
According to the ECHA REACH Guidance, the DNEL was then obtained by applying assessment factors to the starting point:
-Dose response relationship: An assessment factor of1is considered. There is no reason to consider special concern, because the starting point for the DNEL calculation is a NOAEL.
-Differences in duration of exposure:A default assessment factor of6was applied based on the extrapolation from subacute to chronic.
-interspecies differences (allometric scaling): No allometric scaling is considered in the derivation of the inhalation DNEL (ECHA Practical Guide 14, 2012). Differences in the allometry are assumed to be compensated by differences in the respiration rate.
-intraspecies differences: Taking into account the overall toxicity profile of the submission substance and the read across approach, a somewhat more conservative approach is taken and a combined inter-/intraspecies assessment factor of 5 is considered. This is in line with a similar concept developed by the German Committee for Hazardous Substances (AGS 2010).
-Remaining uncertainties: According to ECHA Guidance document, an assessment factor of 2 is considered for route to route extrapolation (oral to inhalation) as a conservative approach.
Since the available data are adequate for labelling and classification purposes of the submission substance, the quality of the data base is judged sufficient for evaluation. Thus, an assessment factor of 1 is applied.
The resulting overall Assessment Factor is 60 (1x 6 x 5 x 2 x1) resulting in a DNEL" long-term inhalation exposure – systemic effects” of 13.2 mg/m3/day.
Acute short-term systemic effects, inhalation:Due to the physico-chemical characteristics of the registration substance and the low vapor pressure, inhalation is not an exposure route of significant concern.The long term systemic inhalation DNEL is considered to be sufficient to ensure that no effects occur. Further,the existing technical and personal risk management measures in place are considered adequate and sufficient to ensure safe use of the substance.
Long-term dermal systemic effects: A DNEL was derived from the oral subacute study, which revealed a NOAEL of 450 mg/kg bw/d, which is used as staring point.According to the ECHA REACH Guidance, the DNEL was then obtained by applying assessment factors to the starting point.
-Differences in duration of exposure:A default assessment factor of 6 was applied based on the extrapolation from subacute to chronic.
-interspecies differences (allometric scaling): An allometric scaling factor of 4 as default is used (ECHA Guidance, ECETOC 2010) (correction for differences in metabolic rate: rat to humans).
-intraspecies differences: According to ECETOC technical Report 110 an assessment Factor of3is considered.
-Dose response relationship: as no conspicious behavior is observed an AF of 1 is taken.
Since the available data are adequate for labelling and classification purposes of the submission substance, the quality of the data base is judged sufficient for evaluation. Thus the assessment factor of 1 is applied.
The resulting overall Assessment Factor is 72 (6 x 4 x 3 x 1 x 1), resulting in a DNEL "long-term dermal exposure - systemic effects" of 6.25 mg/m2/day.
Short-term dermal DNELis not considered applicable. The long-term systemic dermal DNEL is considered to be sufficient to ensure that no effects occur. The registration substance is a skin sensitizer and based hereupon, no dermal exposure is allowed. The existing risk management measures in place are considered adequate and sufficient to ensure safe use of the substance.
Local DNELs:
No DNEL was establishedfor inhalation local effects.The long term systemic inhalation DNEL is considered to be sufficient to ensure that no effects occur.The existing technical and personal risk management measures in place are considered adequate and sufficient to ensure safe use of the substance.
Nolong-term dermal DNEL for local effectswas calculated for the registration substance. The substance is considered to be a skin sensitizer but is not irritating to the skin, thus dermal exposure is strictly to avoid. Therefore, appropriate technical and personal measures to avoid exposure, is mandatory. The technical and personal risk management measures are considered adequate and sufficient to ensure safe use of the registration substance.Long-term local exposure is not anticipated for the worker. Therefore, a qualitative risk assessment was performed.
Short-term dermal DNEL for local effects has not been quantified. Beside the sensitizing property of the substance, it is also causing "irreversible effects to the eye", thus, during handling and use of the material wearing of protective gear has to be considered as absolutely mandatory for workers.The existing technical and personal risk management measures in place are considered adequate and sufficient to ensure safe use of the substance.
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
- Value:
- 10
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:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Assessment factors based on ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not required
- AF for dose response relationship:
- 1
- Justification:
- not required if NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolating subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- adjusting metabolic rates rat to human
- AF for other interspecies differences:
- 1
- Justification:
- not required based on ECETOC Technical Report No. 110
- AF for intraspecies differences:
- 5
- Justification:
- based on ECETOC Technical Report No. 110
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Assessment factors based on ECETOC Technical Report No. 110
- Overall assessment factor (AF):
- 40
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 450 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not required
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General comment to DNEL derivation:
The registration substance is used as paper dye at paper manufacturing sites, and based on available information after the paper dyeing process the dye molecules are fixed to the paper fibres. Based on this the general population is not getting in contact with the material in relevant amounts. Still the oral long term DNEL is being derived for covering a theoretically possible exposure of the population with the substance. Derivation of inhalation and dermal DNELs not applicable based on exposure grounds.
The DNELs derived for the registration substance, mostly have been derived based on studies read-across from the analogue substance (refer to IUCLID section 13). A full justification for the appropriateness of the performed read-across approach is given as an appendix in chapter 13 "Assessment Reports"of this dossier. The most relevant study for DNEL derivation is the oral subacute study on the source substance. Therefore, route-route extrapolation had to be applied for deriving certain DNELs. Derivation of assessment factors are based on ECETOC Technical Report 110.
Systemic DNELs:
No DNELs for inhalation- or dermal exposure to the registration substance are established as there is no use resulting in direct exposure of the general population. Long-term and acute oral systemic DNELs were derived from the oral subacute study, which revealed a NOAEL of 450 mg/kg bw/d.
Long-term oral systemic effects: A DNEL was derived from the oral subacute study, which revealed a NOAEL of 450 mg/kg bw/d and is used as staring point. According to the ECHA REACH Guidance, the DNEL was then obtained by applying assessment factors to the starting point.
-Differences in duration of exposure: A default assessment factor of 6 was applied based on the extrapolation from subacute to chronic.
-interspecies differences (allometric scaling): An allometric scaling factor of 4 as default is used (ECHA Guidance, ECETOC 2010) (correction for differences in metabolic rate: rat to humans).
-intraspecies differences: According to ECETOC technical Report 110 an assessment Factor of 5 is considered.
-Dose response relationship: As no conspicuous behavior is observed an AF of 1 is taken.
Since the available data are adequate for labelling and classification purposes of the submissionsubstance, the quality of the data base is judged sufficient for evaluation. Thus, an assessment factor of 1 is applied.
The resulting overall Assessment Factor is 120 (6 x 4 x 5 x 1 x 1), resulting in a DNEL "long-term oral exposure - systemic effects" of 3.75 mg/kg/day.
The short-term systemic dermal DNEL is not considered applicable, as the registration substance is considered to be fixed to the paper fibres of paper articles and thus resulting in no direct exposure to the general population.
The short-term systemic oral DNEL is calculated by multiplying the long term oral systemic DNEL with a factor of 3 (based on ECETOC Technical Report 110).The resulting DNEL for short-term systemic oral is calculated to be 11.25mg/kg/day.
Local DNELs:
Long-term dermal DNEL for local effects: No long-term local exposure to the registration substance is anticipated for the general population, i.e. based on the paper dyeing process the dye molecules are fixed to the paper fibres and thus the general population is not getting in direct contact with the registration substance, thus, no DNEL for long-term dermal local effects is derived.
Short-term dermal DNEL for local effects has not been quantified. Beside the sensitizing property of the substance, it is also causing "irreversible effects to the eye". Thus, during handling and use of the material wearing of protective gear has to be considered as absolutely mandatory for workers. As the substance registered however is used for the manufacturing of paper, the general population is not involved in such a direct exposure scenario, in this way resulting in no hazard for the eyes of the 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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