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Diss Factsheets
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EC number: 500-537-5 | CAS number: 161075-00-9
- 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:
- 3 088 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 115 210 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 77 191 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation.
The point of departure is a 90-day rat inhalation, rats were exposed 6 h/day, 5 days/week
The effects observed in the available studies of various durations (14, 28 or 90 days, developmental toxicity study) with the analogue substance considered of greater reactivity indicate no increased severity of the effects with time, but more concentration-driven effects (irritation and anaesthetic levels, or liver adaptative effects) that were associated with the highest concentrations.
Thus, no concentration-time correction is applied to the NOAEC in the DNEL derivation.
(NOAEC) 115210 mg/m³ * 6.7 m³ (8h) / 10 m³ (8 h worker light activity) = 77190.7 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect observed at this concentration
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable when setting an inhalation DNEL based on an inhalation animal study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value: Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
- Justification:
- All studies carried out under GLP, K1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties, the surrogate is very close to the target substance.
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
Workers - 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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Basing on the analogue approach between GALDEN LMW and H GALDEN, as described in the appropriate sections and attachments of the dossier, it can be concluded that GALDEN LMW is expected to have the same toxicological profile as H GALDEN. The starting point NOAEC = 115210 mg/m³ derived from a 13 week inhalation toxicity study on H GALDEN is even considered a worst case approach because of the greater reactivity of H GALDEN in respect to GALDEN LMW. This consideration allows being on the safe side in regard to the potential hazard of GALDEN LMW following repeated dose exposure by inhalation
The NOThe NOAEC of 115210 mg/m3 is therefore used as the starting point for the derivation of long-term systemic inhalation DNEL value for workers.
The effects observed in the available studies of various durations (14, 28 or 90 days, developmental toxicity study) with the analogue substance considered of greater reactivity indicate no increased severity of the effects with time, but more concentration-driven effects (irritation and anaesthetic levels, or liver adaptative effects) that were associated with the highest concentrations. Thus, no concentration-time correction is applied to the NOAEC in the DNEL derivation.
GALDEN LMW is not classified for acute toxicity; acute systemic inhalation and acute dermal toxicity. Also, the skin sensitization test is negative. DNEL values are therefore not calculated, in the absence of any hazard.
The substance is not a skin or eye irritant; data available from acute inhalation toxicity study indicate that no respiratory irritation occurs. Local inhalation DNEL values are therefore not calculated.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 304 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 115 210 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation. In addition, the effects observed in the available studies of various durations (14, 28 or 90 days, developmental toxicity study) with the analogue substance considered of greater reactivity indicate no increased effects with time, but more concentration-driven effects (irritation and anaesthetic levels, or liver adaptative effects) that were associated with the highest concentrations.
Thus, no concentration-time correction is applied to the NOAEC in the DNEL derivation.
- AF for dose response relationship:
- 1
- Justification:
- No adverse effect observed at this concentration
- AF for differences in duration of exposure:
- 2
- Justification:
- From sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable when setting an inhalation DNEL based on an inhalation animal study
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value: Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- All studies were conducted following GLP procedures, K1
- AF for remaining uncertainties:
- 1
- Justification:
- No other remaining differences
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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Basing on the analogue approach between GALDEN LMW and H GALDEN, as described in the appropriate sections and attachments of the dossier, it can be concluded that GALDEN LMW is expected to have the same toxicological profile as H GALDEN. The starting point NOAEC = 115210 mg/m³ derived from a 13 week inhalation toxicity study on H GALDEN is even considered a worst case approach because of the greater reactivity of H GALDEN in respect to GALDEN LMW. This consideration allows being on the safe side in regard to the potential hazard of GALDEN LMW following repeated dose exposure by inhalation
The NOAEC of 115210 mg/m3 is therefore used as the starting point for the derivation of long-term systemic inhalation DNEL value for the general population. No route to route extrapolation is needed. In addition, the effects observed in the available studies of various durations (14, 28 or 90 days, developmental toxicity study) with the analogue substance considered of greater reactivity indicate no increased effects with time, but more concentration-driven effects (irritation and anaesthetic levels, or liver adaptative effects) that were associated with the highest concentrations.
Thus, no concentration-time correction is applied to the NOAEC in the DNEL derivation.
GALDEN LMW is not classified for acute toxicity; acute systemic inhalation and acute dermal toxicity. Also, the skin sensitization test is negative. DNEL values are therefore not calculated, in the absence of any hazard.
The substance is not a skin or eye irritant; data available from acute inhalation toxicity study indicate that no respiratory irritation occurs. Local inhalation DNEL values are therefore not calculated.
There was no adverse effects observed in the 28-day oral toxicity study in rats with GALDEN LMW, at up to the limit dose of 1000 mg/kg/day. In addition, no exposure of the general population is expected by the oral route, and the substance is not classified for human health hazard. Thus no DNEL is necessary for the oral route.
No direct dermal exposure to the substance is expected for the general population. In addition prediction using the IH SkinPerm model indicate a very low absorption through the skin whether upon exposure to the liquid or via vapours.
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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