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Diss Factsheets
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EC number: 402-950-5 | CAS number: 87826-41-3 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
- 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
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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:
- 8.46 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):
- 75
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 634.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation required for oral to inhalation route as no long-term inhalation study available.
- AF for dose response relationship:
- 3
- Justification:
- An AF of 3 is considered reasonable based on the use of a precautionary LOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic (90 day study) to chronic studies.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling not required as the differences in allometry (respiration rate and rat to human body sizes) were considered in the conversion from oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted in accordance with generally accepted scientific principles.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 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):
- 300
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 720 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation required for oral to inhalation route as no long term dermal study available.
- AF for dose response relationship:
- 3
- Justification:
- An AF of 3 is considered reasonable based on the use of a precautionary LOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic (90 day study) to chronic studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted in accordance with generally accepted scientific principles.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
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
The substance is not classified for human health.
However, DNELs for long-term systemic effects for inhalation and dermal routes have been derived.
These DNELs have been derived based on the results of the 90 day oral feeding study. Based on the findings of this study, a precautionary LOAEL of 700 - 750 mg/kg bw/day was recommended. The starting point for the DNEL derivations was chosen as 720 mg/kg bw/day, as this was the lowest dose used in the study (for males).
The recommended LOAEL of 700 - 750 mg/kg bw/day is a precautionary result, as the effects observed in the 90 day study could be considered not to be significant/ adverse, and no adverse effects were seen in a 28 -day study or 1 -generation reproduction study.
The DNELs should therefore also be considered precautionary and a worst case assessment.
Inhalation:
Inhalation is not considered to be a significant route of exposure. However, a long-term DNEL for systemic effects have been derived
Long-term systemic effects:
A modification of the dose descriptor starting point (oral to inhalation) was conducted. It is assumed as a worst case assumption that the oral absorption rate is 50% of that of the inhalation absorption. In practice this is unlikely to be the case based on the particle size distribution.
The corrected dose descriptor (NOAEC) for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (see below) for workers (in the case of 8 hour exposure/day).
Default parameters for rats and humans (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle as given in Table R. 8-2 of the above ECHA guidance.
Conversion of an oral rate LOAEL into a correct inhalatory LOAEC to assess human inhalatory exposure:
For workers (in case of 8h exposure/day):
Corrected inhalatory LOAEC = oral LOAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-human) x (sRVhuman / wRV)
Corrected inhalatory LOAEC= 720 mg/kg bw/day x (1 / 0.38 m3/kg/d) x (0.5) x (6.7 m3(8h) / 10 m3(8h))= 634.4 mg/m3
Where:
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
Default parametrs:
sRVrat (8 h) : 0.38m3/kg bw
sRVhuman (8 h) : 6.7 m3/ person
wRV (8 h): 10 m3/ person
The appropriate assessment factors were then applied to give an overall assessment factor of 75
Long-term systemic DNEL (inhalation)= 8.46 mg/m3
Local inhalation effects are not considered to be of concern due to inhalation not being a significant route of exposure and the lack of local effects seen in an acute inhalation study.
Dermal:
A DNEL has been derived for long-term systemic effects by the dermal route.
Long-term systemic DNEL (dermal) = 2.4 mg/kg bw/day
DNELs for local effects have not been derived since the substance is not a skin irritant or sensitiser.
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
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:
- 1.2 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):
- 600
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 720 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not required
- AF for dose response relationship:
- 3
- Justification:
- An AF of 3 is considered reasonable based on the use of a precautionary LOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for sub-chronic (90 day study) to chronic studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF fro general population
- AF for the quality of the whole database:
- 1
- Justification:
- Relevant studies conducted in accordance with generally accepted scientific principles.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
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
The substance is used solely in industry in the manufacture of polyolefin compounds. The substance has no general population/consumer uses so exposure to the general population from use is not anticipated. Once the substance is bound into polyolefin compounds there should be no release, so exposure to the general population from release of the substance from final products is not anticipated.
A DNEL for long term systemic effects via the oral route has been derived, in order to assess indirect exposure of humans via the environment.
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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