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EC number: 283-291-9 | CAS number: 84604-14-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Rosmarinus officinalis, Labiatae.
- 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:
- 14.69 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):
- 18
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point us the oral NOAEL of 300 mg/kg bw. A factor of 2 is applied for route to route extrapolation: oral to inhalation. For animal versus human exposure the following formula is applied: 150*(1/0.38)*6.7/10) = 264.47 mg/m3.
- 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 OECD TG 422 study was derived (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- Since the dose descriptor is derived from an oral OECD TG 422 feeding study, an additional assessment factor of 6 is used to take the extrapolation of subacute data to chronic exposure into account (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 NOEC 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 complication 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:
- ECETOC TR No. 110 (2010) the intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: an OECD TG 422 study according to OECD guideline (and GLP) (ECHA’s Guidance, R.8.4.3.1, November, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.17 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):
- 72
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the toxico-kinetic information it can be anticipated that dermal absorption is expected to be lower than dermal absorption and will not exceed oral absorption. Therefore the starting dose descriptor is the same: 300 mg/kg bw.
- 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 OECD TG 422 study was derived (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- Since the dose descriptor is derived from an OECD TG 422 study, an additional assessment factor of 6 to take account of extrapolation of sub-acute data to chronic exposure (ECHA 2012, Chapter R8, p 29).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- For allometric scaling a factor of 4 is applicable to convert rat to human data, as determined by ECHA 2012, Chapter 8 (Table R.8-3).
- AF for other interspecies differences:
- 1
- Justification:
- Additional assessment factors for interspecies differences are not needed as has been derived in the ECETOC report (TR 110, 2010) based on a review of the scientific literature. The concept of adjusting animal dose by allometric scaling predicts reasonably well the appropriate dose in humans. A Geometric Standard Deviation (GSD) of 2.5-2.6 suggests the likelihood of some variability or additional uncertainty around the predicted NOAEL in humans. This analysis is based on a comparison of animal to actual human data that per se includes intraspecies variability in humans (see below at intraspecies differences).
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC TR No. 110 (2010) the intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: an OECD TG 422 study according to OECD guideline (and GLP) (ECHA’s Guidance, R.8.4.3.1, November, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.35 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point is the NOAEL of 300 mg/kg bw. A factor of 2 is applied for route-to-route extrapolation: oral to inhalation. In addition, for rat to human extrapolation the following formula is used: 150 mg/kg bw /1.15 = 130.43 mg/m3.
- 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 OECD TG 422 study was derived (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- Since the dose descriptor is derived from a OECD TG 422 study, an additional assessment factor of 6 to take account of extrapolation of sub-acute data to chronic exposure (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 in 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:
- ECETOC TR No. 110 (2010) The intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: a 28-day study according to OECD guideline (and GLP) (ECHA’s Guidance, R.8.4.3.1, November, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were 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:
- 2.5 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the toxico-kinetic information it can be anticipated that dermal absorption is expected to be lower than dermal absorption and will not exceed oral absorption. Therefore the starting dose descriptor is the same: 300 mg/kg bw.
- 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 was derived from the OECD TG 422 study (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- Since the dose descriptor is derived from a OECD TG 422 study, an additional assessment factor of 6 to take account of extrapolation of sub-acute data to chronic exposure (ECHA 2012, Chapter R8, p 29)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- For allometric scaling a factor of 4 is applicable to convert rat to human data, as determined by ECHA 2012, Chapter 8 (Table R.8-3)
- AF for other interspecies differences:
- 1
- Justification:
- Additional assessment factors for interspecies differences are not needed as has been derived in the ECETOC report (TR 110, 2010) based on a review of the scientific literature. The concept of adjusting animal dose by allometric scaling predicts reasonably well the appropriate dose in humans. A Geometric Standard Deviation (GSD) of 2.5-2.6 suggests the likelihood of some variability or additional uncertainty around the predicted NOAEL in humans. This analysis is based on a comparison of animal to actual human data that per se includes intraspecies variability in humans (see below at intraspecies differences).
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC TR No. 110 (2010). The intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population) is advised.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: a 28-day study according to OECD guideline (and GLP) (ECHA’s Guidance, R.8.4.3.1, November, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex XI information requirements in accordance with R.7.5-7.7 for assessing long-term systemic toxicity. The NOAEL from a >28-day repeated dose /reproscreen toxicity study is used to derive a DNEL. A DNEL derivation for the oral route is considered necessary, because oral exposure via the environment cannot be excluded.
- 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 was derived from the OECD TG 422 study (ECHA’s guidance, R.8.4.3.1, November, 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- Since the dose descriptor is derived from a OECD TG 422 study, an additional assessment factor of 6 to take account of extrapolation of sub-acute data to chronic exposure (ECHA 2012, Chapter R8, p 29)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- For allometric scaling a factor of 4 is applicable to convert rat to human data. ECETOC (TR110, 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.
- AF for other interspecies differences:
- 1
- Justification:
- Additional assessment factors for interspecies differences are not needed as has been derived in the ECETOC report (TR 110, 2010) based on a review of the scientific literature. The concept of adjusting animal dose by allometric scaling predicts reasonably well the appropriate dose in humans. A Geometric Standard Deviation (GSD) of 2.5-2.6 suggests the likelihood of some variability or additional uncertainty around the predicted NOAEL in humans. This analysis is based on a comparison of animal to actual human data that per se includes intraspecies variability in humans (see below at intraspecies differences).
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC TR No. 110 (2010) the intraspecies variation in humans is greater than that in the more homogenous experimental animal population. Based on an evaluation of the scientific literature by ECETOC, an AF of 3 (for workers) and of 5 (for the general population is advised, after a detailed review of the literature.
- AF for the quality of the whole database:
- 1
- Justification:
- An assessment factor of 1 is applicable because the information fulfils the REACH requirements: a 28-day study according to OECD guideline (and GLP) (ECHA’s Guidance, R.8.4.3.1, November, 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were 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:
- low hazard (no threshold derived)
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.