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EC number: 232-092-5 | CAS number: 7786-17-6
- 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:
- 2.8 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 139 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(oral) converted to NOAEC(inhal) (158 mg/kg x [1/0.38 x 50% oral absorption rat/100% inhalation absorption human x 6.7/10]) = 139 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Limited information on chronic, reproductive and developmental toxicity. (OECD 421 study on highly similar read across substance only)
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
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:
- 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 790 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL (oral) converted to NOAEL (dermal): 158 mg/kg bw/day*50% ABS (oral)/10%ABS(dermal) = 790 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point.
- AF for intraspecies differences:
- 5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
- AF for the quality of the whole database:
- 2
- Justification:
- Limited information on chronic, reproductive and developmental toxicity. (OECD 421 study on highly similar read across substance only)
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment.
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
2,2'-methylenebis(6-nonyl-p-cresol) is not classified for skin/eye irritation or skin sensitisation and is not expected to show any local effects; DNELs for acute exposure and local effects were therefore not calculated. The substance does not possess any genotoxic potential.
The most sensitive endpoint was the NOAEL (158 mg/kg bw/day) obtained in an acceptable 90-day feeding study in rats. The study was performed in line with good scientific principles and reported to a high standard. In accordance with Klimisch (1997) the study was assigned a reliability score of 1. This NOAEL was used as the starting point for the calculation of systemic DNELs. The reproductive and developmental toxicity was investigated in a study performed in accordance with standardised guidelines OECD 421 and EPA OPPTS 870.3550 using an appropriate test material suitable for read-across to support 2,2'-methylene-bis(6-nonyl-p-cresol); this study showed no effect at the highest dose tested. Also by read-across, no evidence of carcinogenicity was seen in acceptable studies; however the highest doses tested for carcinogenicity by read-across were of the same magnitude as the key 90-day NOAEL of the test material. An additional factor of 2 for completeness of the database is therefore applied.
For the purposes of human risk assessment there is sufficient information to consider that 2,2'-methylene-bis(6-nonyl-p-cresol) would be partially absorbed (50%) by the oral route, and slowly metabolised and excreted. The consequences of slow metabolism and excretion are however adequately addressed within the NOAEL of a 90-day study. Human dermal absorption may be considered to be 10%; inhalation absorption is assumed to be complete.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 100
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 69 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(oral) converted to NOAEC(inhal) (158 mg/kg x [1/1.15 x 50% oral absorption rat/100% inhalation absorption human) = 69 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Limited information on chronic, reproductive and developmental toxicity. (OECD 421 study on highly similar read across substance only)
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
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:
- 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):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 790 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL (oral) converted to NOAEL (dermal): 158 mg/kg bw/day*50% ABS (oral)/10%ABS(dermal) = 790 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Limited information on chronic, reproductive and developmental toxicity. (OECD 421 study on highly similar read across substance only)
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
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:
- 0.4 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):
- 400
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 158 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assumed that the oral absorption in rat and humans is the same
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from subchronic study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in calculation of dose descriptor starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Limited information on chronic, reproductive and developmental toxicity. (OECD 421 study on highly similar read across substance only)
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
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
2,2'-methylenebis(6-nonyl-p-cresol) is not classified for skin/eye irritation or skin sensitisation and is not expected to show any local effects; DNELs for acute exposure and local effects were therefore not calculated. The substance does not possess any genotoxic potential.
The most sensitive endpoint was the NOAEL (158 mg/kg bw/day) obtained in an acceptable 90-day feeding study in rats. The study was performed in line with good scientific principles and reported to a high standard. In accordance with Klimisch (1997) the study was assigned a reliability score of 1. This NOAEL was used as the starting point for the calculation of systemic DNELs. The reproductive and developmental toxicity was investigated in a study performed in accordance with standardised guidelines OECD 421 and EPA OPPTS 870.3550 using an appropriate test material suitable for read-across to support 2,2'-methylene-bis(6-nonyl-p-cresol); this study showed no effect at the highest dose tested. Also by read-across, no evidence of carcinogenicity was seen in acceptable studies; however the highest doses tested for carcinogenicity by read-across were of the same magnitude as the key 90-day NOAEL of the test material. An additional factor of 2 for completeness of the database is therefore applied.
For the purposes of human risk assessment there is sufficient information to consider that 2,2'-methylene-bis(6-nonyl-p-cresol) would be partially absorbed (50%) by the oral route, and slowly metabolised and excreted. The consequences of slow metabolism and excretion are however adequately addressed within the NOAEL of a 90-day study. Human dermal absorption may be considered to be 10%; inhalation absorption is assumed to be complete.
The same endpoint used for workers was selected for setting the long-term DNELs for the general population. The larger assessment factor for intraspecies sensitivity was considered adequately protective for the more sensitive 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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