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Diss Factsheets
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EC number: 269-085-1 | CAS number: 68187-30-4
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 60 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):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal absorption is not considered to be higher than oral absorption, default extrapolation factor: 1
- AF for dose response relationship:
- 1
- Justification:
- No effects were observed, dose response is therefore irrelevant.
- AF for differences in duration of exposure:
- 1
- Justification:
- As no effects were observed, no time extrapolation was performed. Worsening of effects is not expecte with time.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No effects were observed. The cleavage products are food ingredients, therefore toxicodynamic differences are not expected
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- All relevant endpoints are covered
- AF for remaining uncertainties:
- 1
- Justification:
- Remaining uncertainties are not expected
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
The substance does not cause systemic effects and the only local effect was eye irritation. A 112 day oral toxicity study in the rat is available for DNEL derivation. Because of the low vapor pressure and the identified exposure scenarios, inhalation exposure to the substance is not expected. Instead, a dermal DNEL was derived according to ECHA Guidance on Information requirements and chemical safety assessment Chapter R.8 (2008).
Route to route extrapolation: The oral NOAEL of > 1200 mg/kg bw was converted to a dermal NOAEL of the same magnitude as dermal absorption is not expected to be higher than oral absorption. Allometric scaling was applied for rat to human with a factor of 4. Toxicodynamic differences between rats and humans are not expected to play a role as the cleavage products of the substance are food ingredients that are consumed on a gram bases by humans. The default factor extrapolation for workers (5) was used for interspecies extrapolation. Because no effect was observed in the subchronic study, it is difficult to imagine a worsening with exposure duration. Therfore, time extrapolation was not performed.
For the worker, wearing of goggles is reccomended because of the eye irritant properties of the neat material.
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:
- DNEL (Derived No Effect Level)
- Value:
- 30 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal absorption is not considered to be higher than oral absorption, default extrapolation factor: 1
- AF for dose response relationship:
- 1
- Justification:
- No effects were observed, dose response is therefore irrelevant
- AF for differences in duration of exposure:
- 1
- Justification:
- As no effects were observed, no time extrapolation was performed. Worsening of effects is not expecte with time.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No effects were observed. The cleavage products are food ingredients, therefore toxicodynamic differences are not expected
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- All relevant endpoints are covered
- AF for remaining uncertainties:
- 1
- Justification:
- Remaining uncertainties are not expected
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation needed to be performed
- AF for dose response relationship:
- 1
- Justification:
- No effects were observed, dose response is therefore irrelevant
- AF for differences in duration of exposure:
- 1
- Justification:
- As no effects were observed, no time extrapolation was performed. Worsening of effects is not expecte with time.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- No effects were observed. The cleavage products are food ingredients, therefore toxicodynamic differences are not expected
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- All relevant endpoints are covered
- AF for remaining uncertainties:
- 1
- Justification:
- Remaining uncertainties are not expected
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The substance does not cause systemic effects and the only local effect was eye irritation. A 112 day oral toxicity study in the rat is available for DNEL derivation. Because of the low vapor pressure and the identified exposure scenarios, inhalation exposure to the substance is not expected. Instead, a dermal and oral DNEL was derived according to ECHA Guidance on Information requirements and chemical safety assessment Chapter R.8 (2008).
Route to route extrapolation: The oral NOAEL of > 1200 mg/kg bw was converted to a dermal NOAEL of the same magnitude as dermal absorption is not expected to be higher than oral absorption. For the oral DNEL, no route to route extrapolation was performed. Allometric scaling was applied for rat to human with a factor of 4. Toxicodynamic differences between rats and humans are not expected to play a role as the cleavage products of the substance are food ingredients that are consumed on a gram bases by humans. The default factor extrapolation for the general population (10) was used for interspecies extrapolation. Because no effect was observed in the subchronic study, it is difficult to imagine a worsening with exposure duration. Therfore, time extrapolation was not performed.
The substance is not expected to be an eye irritant when used in consumer formulations, hence no risk mitigation is required.
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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