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Registration Dossier
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EC number: 240-400-4 | CAS number: 16324-27-9
- 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:
- 14.8 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 370.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC (human worker) = NOAEL * (1/0.38 m³/kg bw) * 6.7 m³/10 m³* (7/5) * 0.5 = 300*(1/0.38) *6.7/10*7/5 *0.5 = 370.26 (0.38 m³/kg bw: default respiratory volume for the rat corresponding to the daily duration of human exposure. For workers a correction is needed for the difference between respiratory rates under standard conditions and under conditions of light activity. Since worker are exposed 5 days per week and the rats were exposed 7 days per week a factor 7/5 was included.
No experimental data on absorption via inhalation route was available. Worst case assumption for absorption was: 50 % orally and 100 % by inhalation = 0.5 correction for inhlation)
Thus, the corrected starting point for workers was 370.26 mg/m³/d for inhalation.
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 2
- Justification:
- From subchronic study to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC Human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- NAEC Human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP studies compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- carcinogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- other: Corrected NOAEL
- Value:
- 420 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The corrected starting point for the dermal route for workers: = NOEL*(7/5) = 420 mg/kg bw/day.
No correction from oral to dermal absorption was applied.
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 2
- Justification:
- From sub-chronic to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- Justification:
- GLP studies compliant with international guideline
- AF for remaining uncertainties:
- 1
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:
- carcinogenicity
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:
- no hazard identified
Additional information - workers
The substance under registration belongs to the category of Stilbene Fluorescent Whitening Agents. This substance and all other members of this category do not show acute toxic effects after oral, inhalation, and dermal administration. They are neither irritant to skin nor eyes, nor genotoxic in-vitro and in-vivo, nor sensitizing. Many substances within this category were tested for subchronic toxicity and four of them were tested for chronic toxicity up to two years with no relevant toxic effects.
In the two generation study performed on rat dosed with OB 3a-MSA a NOAEL of 300 was set for parental toxicity (Turk A.P., 2000).
Based on the parental toxicity in the rat two generation study, the NOAEL of 300 mg/Kg bw/day has been considered as representative, for hazard assessment.
The DNELs for inhalation and dermal long-term exposure are derived from the no observed effect level obtained from this oral toxicity study. In general, the calculation of DNEL is based on the observed effect level, which has to be modified.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.61 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected starting point for the inhalation route for general population: = NOAEL * (1/1.15 m³/kg bw/day)*0.5 (1.15 m³/kg bw/day: default respiratory volume for the rat corresponding to the daily duration of human exposure.
No data on absorption via inhalation route was available. Worst case assumption for absorption was: 50 % orally and 100 % by inhalation = 0.5 correcting factor for absorbtion via inhalation)
Thus, the corrected starting point for the general population was 130.43 mg/m³ for inhalation. Subsequently other assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining differences (2.5), intraspecies differences: general population (10), difference in duration of exposure (2). The DNEL for long-term inhalation exposure, systemic effects is therefore considered to be 2.61 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC Human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- NAEC Human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP studies compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- carcinogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- other: Corrected NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point for the dermal route for general population: = NOAELoral = 300 mg/kg bw/day (
No correction from oral to dermal absorption was applied.
Following assessment factors are taken into account for the final DNEL calculation of systemic dermal effects: interspecies differences: human-rat (allometric scaling factor of 4), remaining differences (2.5), intraspecies differences: general population (10), difference in duration of exposure (2).
The resulting DNEL for long-term dermal systemic effects of Stilbene Fluorescent Whitening Agents was 1.5 mg/kg bw/d for general population.
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP studies compliant with international guideline
- AF for remaining uncertainties:
- 1
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:
- carcinogenicity
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:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No extrapolation
- AF for dose response relationship:
- 1
- Justification:
- good data about curve dose/response
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP studies compliant with international guideline
- AF for remaining uncertainties:
- 1
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:
- no hazard identified
Additional information - General Population
The substance under registration belongs to the category of Stilbene Fluorescent Whitening Agents. This substance and all other members of this category do not show acute toxic effects after oral, inhalation, and dermal administration. They are neither irritant to skin nor eyes, nor genotoxic in-vitro and in-vivo, nor sensitizing. In the 24 month chronic toxicity study in the rat, conducted on the acid form of the dihydroxyethylamino disulphonated derivative, no treatment-related clinical symptoms and no signs of systemic toxicity were observed throughout the study. Many substances within the category were tested for subchronic toxicity and four of them were tested for chronic toxicity up to two years with no relevant toxic effects.
In the two generation study performed on rat dosed with OB 3a-MSA a NOAEL of 300 was set for parental toxicity.
Based on the parental toxicity in the rat two generation study, the NOAEL of 300 mg/Kg bw/day has been considered as representative, for hazard assessment.
The DNELs for inhalation and dermal long-term exposure are derived from the no observed effect level obtained from this oral toxicity study with this substance.
In general, the calculation of DNEL is based on the observed effect level, which has to be modified.
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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