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EC number: 281-092-1 | CAS number: 83863-30-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cananga odorata, Annonaceae.
- 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:
- 22.24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110
- Overall assessment factor (AF):
- 28.44
- Dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 632.59 mg/m³
- Explanation for the modification of the dose descriptor starting point:
-Route-to-route: IGHRC Guidelines, April 2006 and ECHA 2012, Ch R.8, p19 in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) in the case of oral-toinhalation extrapolation. The inclusion of this factor 2 means for example that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation.
-Bioavailability differences between human and animal species: No evidence for a difference between species for oral exposure to testsubstance
-Bioavailability differences between test and target substances: Not applicable
-Modification for exposure (experiment in animal and human): ECHA Ch R.8, 2012: Modification for exposure for workers - 8 h exposure /day = 1/sRV rat (8h)= 1/0.38 m3/kg/d. Applicable worker = 1/0.38; Applicable general population = 1/1.15
-Modification for the respiratory volume: ECHA Ch R.8, 2012, p 20: Respiratory volume light activity, standard conditions for worker - 8 hour (sRV human = 6.7 m3/kg/d) with relevant duration of 8 h - respiratory volume / exposure of 10 m3 (wRV). Applicable worker = 6.7/10
- AF for dose response relationship:
- 1
- Justification:
- No additional assessment factor for dose response is needed because the dosing was well spaced in the study and a NOAEL in the 28-day/reproscreening study was derived (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- (ii) 6 for duration exposure / Since the dose descriptor is derived from a 28-day study, an additional assessment factor of 6 to take account of extrapolation of subacute data to chronic exposure; subacute to sub-chronic = 3 and sub-chronic to chronic = 2 and subacute to chronic = 6 ; sub-chronic’ usually refers to a 90 day study; ‘sub-acute’ usually refers to a 28 day study; ‘chronic’ usually refers to a 1.5 - 2 year study (for rodents) (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor of 1 has been used because the difference in metabolic rate between rat and humans has been accounted for in the conversion of NOAEL in mg/kg bw to the NOAEC mg/m3, as presented in ECHA’s guidance R.8, figure R. 8-2 (November, 2012).
- AF for other interspecies differences:
- 1
- Justification:
- An assessment factor of 1 has been applied because besides allometric differences no other interspecies differences need to be accounted for which has been shown by ECETOC TR 110 (2010) after a review of the scientific literature. ECETOC concludes that adjusting animal dose by allometric scaling predicts reasonably well the appropriate dose in humans. The application the ‘remaining’ AF of 2.5 for interspecies variability would mean an unjustified compilation of AF. The ‘residual’ interspecies variability may remain following allometric scaling, but this is largely accounted for in the default AF proposed for intraspecies variability, i.e. reflecting the interdependency of inter- and intraspecies AF
- AF for intraspecies differences:
- 3
- Justification:
- There is a major difference in the AF proposed by the REACH TGD and ECETOC for intraspecies extrapolation of systemic effects if the Point of Departure is derived from animal studies (worker: REACH TGD 5, ECETOC 3; general population: REACH TGD 10, ECETOC 5). The proposal of ECETOC is based on an evaluation of the scientific literature while the REACH TGD refers to standard default procedures. Therefore, for the evaluation of Ylang Ylang I oil the ECETOC TR No. 110 (2010) is followed until the scientific basis for using an alternative approach has been established.
- AF for the quality of the whole database:
- 1.58
- Justification:
- An additional assessment factor of 1 is considered appropriate. The study used is highly reliable. In accordance with Guidance R.8 a positive result in OECD TG 421/422 may be considered sufficient for the calculation of a DNELfertility and/or a DNELdevelopment; however, an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take account of the lower sensitivity of the study, unless there is evidence to support that the lower sensitivity is not relevant for the effect mechanism of the substance (e.g. specific teratogenic effects that are the result of a known mechanism of action). Based on ECETOC TR 110: the larger group sizes of the OECD TG 416 study design afford a probability of detecting a statistically significant difference, and therefore a NOAEL, that is between √2 and √2.5 lower (1.41- to 1.58-fold) than that of OECD TG 421 and OECD TG 422.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 21.12 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110
- Overall assessment factor (AF):
- 227.52
- Dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 805.89 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
-Route-to-route: Oral-Dermal; On the assumption that, in general, dermal absorption will not be higher than oral absorption, no factor should be introduced when performing oral-to-dermal extrapolation. With SkinPerm it was determined that for the constituents >1% in the UVCB a weighed dermal absorption of 7.47% can be used for this substance.
-Bioavailability differences between human and animal species: No evidence for a difference between species for oral exposure to testsubstance
-Bioavailability differences between test and target substances: Not applicable
-Modification for exposure (experiment in animal and human): Not applicable
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1. ECHA, 2012, Chapter R8
- AF for differences in duration of exposure:
- 6
- Justification:
- (ii) 6 for duration exposure / Since the dose descriptor is derived from a 28-day study, an additional assessment factor of 6 to take account of extrapolation of subacute data to chronic exposure; subacute to sub-chronic = 3 and sub-chronic to chronic = 2 and subacute to chronic = 6 ; sub-chronic’ usually refers to a 90 day study; ‘sub-acute’ usually refers to a 28 day study; ‘chronic’ usually refers to a 1.5 - 2 year study (for rodents) (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from Rat to Humans
- AF for other interspecies differences:
- 1
- Justification:
- Correction for remaining difference i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).[ECHA, 2012, Chapter R8, 32]. ECETOC (TR No. 110 (2010)) supports the inclusion of the factor for allometry, but considers that routine application of the factor of 2.5 is unjustified as a default factor. For interspecies extrapolation for systemic effects of Ylang Ylang I, both toxicokinetic and toxicodynamic aspects should be considered. Toxicokinetics are covered by the principle of allometric scaling, with a factor of 4 for rats to humans, as the default approach. Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination. Therefore, for the derivation for the DNEL for Ylang Ylang I the factor 2.5 for remaining differences including toxicodynamics is considered unnecessary.
- AF for intraspecies differences:
- 3
- Justification:
- There is a major difference in the AF proposed by the REACH TGD and ECETOC for intraspecies extrapolation of systemic effects if the Point of Departure is derived from animal studies (worker: REACH TGD 5, ECETOC 3; general population: REACH TGD 10, ECETOC 5). The proposal of ECETOC is based on an evaluation of the scientific literature while the REACH TGD refers to standard default procedures. Therefore, for the evaluation of the substance the ECETOC TR No. 110 (2010) is followed until the scientific basis for using an alternative approach has been established.
- AF for the quality of the whole database:
- 3.16
- Justification:
- An additional assessment factor of 1 is considered appropriate. The study used is highly reliable. In accordance with Guidance R.8 a positive result in OECD TG 421/422 may be considered sufficient for the calculation of a DNELfertility and/or a DNELdevelopment; however, an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take account of the lower sensitivity of the study, unless there is evidence to support that the lower sensitivity is not relevant for the effect mechanism of the substance (e.g. specific teratogenic effects that are the result of a known mechanism of action). Based on ECETOC TR 110: the larger group sizes of the OECD TG 416 study design afford a probability of detecting a statistically significant difference, and therefore a NOAEL, that is between √2 and √2.5 lower (1.41- to 1.58-fold) than that of OECD TG 421 and OECD TG 422. An additional assessment factor of 2 is considered appropriate as modelling (SkinPerm) has been used for dermal absorption estimation.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.59 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC TR 110
- Overall assessment factor (AF):
- 47.4
- Dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 312.33 mg/m³
- Explanation for the modification of the dose descriptor starting point:
-Route-to-route: IGHRC Guidelines, April 2006 and ECHA 2012, Ch R.8, p19 in the absence of route-specific information on the starting route, to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) in the case of oral-toinhalation extrapolation. The inclusion of this factor 2 means for example that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation.
-Bioavailability differences between human and animal species: No evidence for a difference between species for oral exposure to testsubstance
-Bioavailability differences between test and target substances: Not applicable
-Modification for exposure (experiment in animal and human): ECHA Ch R.8, 2012: Modification for exposure for workers - 8 h exposure /day = 1/sRV rat (8h)= 1/0.38 m3/kg/d. Applicable worker = 1/0.38; Applicable general population = 1/1.15
-Modification for the respiratory volume: ECHA Ch R.8, 2012, p 20: Respiratory volume light activity, standard conditions for worker - 8 hour (sRV human = 6,7 m3/kg/d) with relevant duration of 8 h - respiratory volume / exposure of 10 m3 (wRV). Applicable worker = 6.7/10
- AF for dose response relationship:
- 1
- Justification:
- No additional assessment factor for dose response is needed because the dosing was well spaced in the study and a NOAEL in the 28-day/reproscreening study was derived (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- (ii) 6 for duration exposure / Since the dose descriptor is derived from a 28-day study, an additional assessment factor of 6 to take account of extrapolation of subacute data to chronic exposure; subacute to sub-chronic = 3 and sub-chronic to chronic = 2 and subacute to chronic = 6 ; sub-chronic’ usually refers to a 90 day study; ‘sub-acute’ usually refers to a 28 day study; ‘chronic’ usually refers to a 1.5 - 2 year study (for rodents) (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An assessment factor of 1 has been used because the difference in metabolic rate between rat and humans has been accounted for in the conversion of NOAEL in mg/kg bw to the NOAEC mg/m3, as presented in ECHA’s guidance R.8, figure R. 8-2 (November, 2012).
- AF for other interspecies differences:
- 1
- Justification:
- An assessment factor of 1 has been applied because besides allometric differences no other interspecies differences need to be accounted for which has been shown by ECETOC TR 110 (2010) after a review of the scientific literature. ECETOC concludes that adjusting animal dose by allometric scaling predicts reasonably well the appropriate dose in humans. The application the ‘remaining’ AF of 2.5 for interspecies variability would mean an unjustified compilation of AF. The ‘residual’ interspecies variability may remain following allometric scaling, but this is largely accounted for in the default AF proposed for intraspecies variability, i.e. reflecting the interdependency of inter- and intraspecies AF.
- AF for intraspecies differences:
- 5
- Justification:
- There is a major difference in the AF proposed by the REACH TGD and ECETOC for intraspecies extrapolation of systemic effects if the Point of Departure is derived from animal studies (worker: REACH TGD 5, ECETOC 3; general population: REACH TGD 10, ECETOC 5). The proposal of ECETOC is based on an evaluation of the scientific literature while the REACH TGD refers to standard default procedures. Therefore, for the evaluation of Ylang Ylang I oil the ECETOC TR No. 110 (2010) is followed until the scientific basis for using an alternative approach has been established.
- AF for the quality of the whole database:
- 1.58
- Justification:
- An additional assessment factor of 1 is considered appropriate. The study used is highly reliable. In accordance with Guidance R.8 a positive result in OECD TG 421/422 may be considered sufficient for the calculation of a DNELfertility and/or a DNELdevelopment; however, an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take account of the lower sensitivity of the study, unless there is evidence to support that the lower sensitivity is not relevant for the effect mechanism of the substance (e.g. specific teratogenic effects that are the result of a known mechanism of action). Based on ECETOC TR 110: the larger group sizes of the OECD TG 416 study design afford a probability of detecting a statistically significant difference, and therefore a NOAEL, that is between √2 and √2.5 lower (1.41- to 1.58-fold) than that of OECD TG 421 and OECD TG 422.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 12.67 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):
- 379.2
- Dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 805.89 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
-Route-to-route: Oral-Dermal; On the assumption that, in general, dermal absorption will not be higher than oral absorption, no factor should be introduced when performing oral-to-dermal extrapolation. With SkinPerm it was determined that for the constituents >1% in the UVCB a weighed dermal absorption of 7.47% can be used for this substance.
-Bioavailability differences between human and animal species: No evidence for a difference between species for oral exposure to testsubstance
-Bioavailability differences between test and target substances: Not applicable
-Modification for exposure (experiment in animal and human): Not applicable
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1. ECHA, 2012, Chapter R8
- AF for differences in duration of exposure:
- 6
- Justification:
- (ii) 6 for duration exposure / Since the dose descriptor is derived from a 28-day study, an additional assessment factor of 6 to take account of extrapolation of subacute data to chronic exposure; subacute to sub-chronic = 3 and sub-chronic to chronic = 2 and subacute to chronic = 6 ; sub-chronic’ usually refers to a 90 day study; ‘sub-acute’ usually refers to a 28 day study; ‘chronic’ usually refers to a 1.5 - 2 year study (for rodents) (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from Rat to Humans
- AF for other interspecies differences:
- 1
- Justification:
- Correction for remaining difference i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).[ECHA, 2012, Chapter R8, 32]. ECETOC (TR No. 110 (2010)) supports the inclusion of the factor for allometry, but considers that routine application of the factor of 2.5 is unjustified as a default factor. For interspecies extrapolation for systemic effects of Ylang Ylang I oil, both toxicokinetic and toxicodynamic aspects should be considered. Toxicokinetics are covered by the principle of allometric scaling, with a factor of 4 for rats to humans, as the default approach. Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination. Therefore, for the derivation for the DNEL for Ylang Ylang I oil the factor 2.5 for remaining differences including toxicodynamics is considered unnecessary.
- AF for intraspecies differences:
- 5
- Justification:
- There is a major difference in the AF proposed by the REACH TGD and ECETOC for intraspecies extrapolation of systemic effects if the Point of Departure is derived from animal studies (worker: REACH TGD 5, ECETOC 3; general population: REACH TGD 10, ECETOC 5). The proposal of ECETOC is based on an evaluation of the scientific literature while the REACH TGD refers to standard default procedures. Therefore, for the evaluation of the substance the ECETOC TR No. 110 (2010) is followed until the scientific basis for using an alternative approach has been established.
- AF for the quality of the whole database:
- 3.16
- Justification:
- An additional assessment factor of 1 is considered appropriate. The study used is highly reliable. In accordance with Guidance R.8 a positive result in OECD TG 421/422 may be considered sufficient for the calculation of a DNELfertility and/or a DNELdevelopment; however, an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take account of the lower sensitivity of the study, unless there is evidence to support that the lower sensitivity is not relevant for the effect mechanism of the substance (e.g. specific teratogenic effects that are the result of a known mechanism of action). Based on ECETOC TR 110: the larger group sizes of the OECD TG 416 study design afford a probability of detecting a statistically significant difference, and therefore a NOAEL, that is between √2 and √2.5 lower (1.41- to 1.58-fold) than that of OECD TG 421 and OECD TG 422. An additional assessment factor of 2 is considered appropriate as modelling (SkinPerm) has been used for dermal absorption estimation.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- 3.79 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):
- 189.6
- Dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 718 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
-Route-to-route: Oral to dermal extrapolation with the same units (ECHA, 2012, p67 and and p18-20); (oral absorption / absorption by dermal exposure); Therefore, default values of 50, 100 and 100% for oral, dermal and inhalation absorption respectively, will be used for the exposure and risk assessment calculations for operators, workers and by standards.
-Bioavailability differences between human and animal species: Corrected dermal NOAEL = oral NOAEL * (ABSoral rat/ABSderm human);
-Bioavailability differences between test and target substances: Not relevant
-Modification for exposure (experiment in animal and human): Not relevant
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL, the default assessment factor, as a standard procedure, is 1. ECHA, 2012, Chapter R8
- AF for differences in duration of exposure:
- 6
- Justification:
- (ii) 6 for duration exposure / Since the dose descriptor is derived from a 28-day study, an additional assessment factor of 6 to take account of extrapolation of subacute data to chronic exposure; subacute to sub-chronic = 3 and sub-chronic to chronic = 2 and subacute to chronic = 6 ; sub-chronic’ usually refers to a 90 day study; ‘sub-acute’ usually refers to a 28 day study; ‘chronic’ usually refers to a 1.5 - 2 year study (for rodents) (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from Rat to Humans
- AF for other interspecies differences:
- 1
- Justification:
- Correction for remaining difference i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).[ECHA, 2012, Chapter R8, 32]. ECETOC (TR No. 110 (2010)) supports the inclusion of the factor for allometry, but considers that routine application of the factor of 2.5 is unjustified as a default factor. For interspecies extrapolation for systemic effects of Ylang Ylang I oil, both toxicokinetic and toxicodynamic aspects should be considered. Toxicokinetics are covered by the principle of allometric scaling, with a factor of 4 for rats to humans, as the default approach. Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination. Therefore, for the derivation for the DNEL for Ylang Ylang I oil the factor 2.5 for remaining differences including toxicodynamics is considered unnecessary.
- AF for intraspecies differences:
- 5
- Justification:
- There is a major difference in the AF proposed by the REACH TGD and ECETOC for intraspecies extrapolation of systemic effects if the Point of Departure is derived from animal studies (worker: REACH TGD 5, ECETOC 3; general population: REACH TGD 10, ECETOC 5). The proposal of ECETOC is based on an evaluation of the scientific literature while the REACH TGD refers to standard default procedures. Therefore, for the evaluation of Ylang Ylang I oil the ECETOC TR No. 110 (2010) is followed until the scientific basis for using an alternative approach has been established.
- AF for the quality of the whole database:
- 1.58
- Justification:
- An additional assessment factor of 1 is considered appropriate. The study used is highly reliable. In accordance with Guidance R.8 a positive result in OECD TG 421/422 may be considered sufficient for the calculation of a DNELfertility and/or a DNELdevelopment; however, an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take account of the lower sensitivity of the study, unless there is evidence to support that the lower sensitivity is not relevant for the effect mechanism of the substance (e.g. specific teratogenic effects that are the result of a known mechanism of action). Based on ECETOC TR 110: the larger group sizes of the OECD TG 416 study design afford a probability of detecting a statistically significant difference, and therefore a NOAEL, that is between √2 and √2.5 lower (1.41- to 1.58-fold) than that of OECD TG 421 and OECD TG 422.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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
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.