Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-004-1 | CAS number: 4602-84-0
- 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:
- 1.85 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 92.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects in workers after long-term inhalation exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- was derived via route-to-route extrapolation from the lowest NOAEL obtained in the sub acute repeated dose toxicity and reproductive toxicity screening study in rats (105 mg/kg bw/day) with dosing over a prolonged period (approximately 36 days in males and 57 days in females) with the read-across substance, Nerolidol. To convert the oral NOAEL in rats to an inhalation NOAEC in humans, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 0.38m3/kg bw/8h). For workers a correction was added for the difference between respiratory rates under standard conditions (sRVhuman: 6.7 m3 for an 8h exposure period) and under conditions of light activity (wRV: 10 m3 for an 8h exposure period); extrapolation from 50% bioavailability oral to 100% bioavailability inhalation. Therefore, inhalatory NOAEC = oral NOAEL*(1/sRVrat 8h)*(ABSoral/ABSinh)*(sRVhuman/wRV) OR 105*(1/0.38)*(50/100)*(6.7/10) = 92.57. This Therefore, DNEL = Corrected inhalation NOAEC (92.57 mg/m3)*(1/50{Overall AF}) = 1.85 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Not required as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 4
- Justification:
- The duration of exposure in the key study providing the point of departure NOAEL was 36 days for male rats and 57 days for female rats. These exposure durations fall between the descriptors for subchronic (90 days) and subacute (28 days) in the guidance document. Since adaptive hepatotoxicity was observed in animals from this study, a modification to the exposure duration AF was made fro the conservative AF6 to AF4
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required when route to route extrapolation conducted
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.32 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects in workers after long-term dermal exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- was derived via route-to-route extrapolation from the lowest NOAEL of 105 mg/kg bw/day obtained in the sub acute oral repeated dose toxicity and reproductive toxicity screening study in rats with the read-across substance, Nerolidol. Therefore, DNEL = 105 mg/kg bw/day*(1/4{modified exposure duration sub acute to chronic}*4{allometric scaling rat-human}*2.5{interspecies differences}*5{intraspecies differences-worker population}) = 0.525 mg/kg bw/day. This is considered to be the worst-case scenario assuming 100% dermal absorption hence 100% bioavailability and systemic exposure at this level, however, dermal absorption has been determined to be 39.8% of the applied dose in a key dermal absorption study with radiolabelled 3,7,11-trimethyldodeca-2,6,10-trien-1-ol in guinea pigs. Therefore, the DNEL should be adjusted by a factor of 100/39.8 to allow for this absorption profile i.e. adjusted DNEL = 0.35*(100/39.8) = 1.32 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Not required as starting point is NOAEL
- AF for differences in duration of exposure:
- 4
- Justification:
- The duration of exposure in the key study providing the point of departure NOAEL was 36 days for male rats and 57 days for female rats. These exposure durations fall between the descriptors for subchronic (90 days) and subacute (28 days) in the guidance document. Since adaptive hepatotoxicity was observed in animals from this study, a modification to the exposure duration AF was made fro the conservative AF6 to AF4
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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
The basis for the inhalation and dermal systemic DNELs for worker exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- is an oral subacute repeated dose toxicity study and reproductive toxicity screening study with the read-across substance, Nerolidol , from which the lowest NOAEL of 1500 ppm (equivalent to 105 mg/kg bw/day for F0 parental females) was identified. The NOAEL in parental males was identified as 4000 ppm (equivalent to 266 mg/kg/day). This study was of a prolonged duration (approximately 36 days in males and 57 days in females) and resulted in reduced body weight gains, reduced food intake and hepatotoxicity in males and females at the high dietary inclusion level of 12000 ppm and also in females treated with 4000 ppm. The lowest NOAEL (No Observed Adverse Effect Level) of 105 mg/kg bw/day was used as the basis of the DNEL calculations using appropriate assessment factors for relevant indicators including route to route extrapolation, allometric scaling, exposure duration and study length. For local effects it is considered that the systemic DNEL for inhalation exposure would be protective for this exposure in the absence of specific data. For dermal exposure the combination of acute dermal data and dermal absorption studies would indicate only a medium hazard.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.457 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 45.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects in general population after long-term inhalation exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- was derived via route-to-route extrapolation from the NOAEL obtained in the sub acute oral repeated dose toxicity and reproductive toxicity screening study in rats (105 mg/kg bw/day) with dosing over a prolonged period (approximately 36 days in males and 57 days in females) with the read-across substance, Nerolidol. To convert oral rat NOAEL into inhalatory NOAEC in humans, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 1.15 m3/kg bw/24h); extrapolation from 50% bioavailability oral to 100% bioavailability inhalation. Therefore, the corrected inhalation NOAEC for general population is oral NOAEL*(1/sRVrat 24h)*(ABSoral/ABSinh) or 105*(1/1.15)*(50/100) = 45.7 mg/m3. Therefore, DNEL = Corrected inhalation NOAEC (45.7 mg/m3)*(1/100{Overall AF}) = 0.457 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Not required as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 4
- Justification:
- The duration of exposure in the key study providing the point of departure NOAEL was 36 days for male rats and 57 days for female rats. These exposure durations fall between the descriptors for subchronic (90 days) and subacute (28 days) in the guidance document. Since adaptive hepatotoxicity was observed in animals from this study, a modification to the exposure duration AF was made fro the conservative AF6 to AF4
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required when route to route extrapolation is conducted
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.66 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects in the general population after long-term dermal exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- was derived via route-to-route extrapolation from the lowest NOAEL of 105 mg/kg bw/day obtained in the sub acute oral repeated dose toxicity and reproductive toxicity screening study in rats with the read-across substance, Nerolidol. Therefore, DNEL = 105 mg/kg bw/day*(1/4{modified exposure duration sub acute to chronic}*4{allometric scaling rat-human}*2.5{interspecies differences}*10{intraspecies differences-general population}) = 0.263 mg/kg bw/day. This is considered to be the worst-case scenario assuming 100% dermal absorption hence 100% bioavailability and systemic exposure at this level, however, dermal absorption has been determined to be 39.8% of the applied dose in a key dermal absorption study with radiolabelled 3,7,11-trimethyldodeca-2,6,10-trien-1-ol in guinea pigs. Therefore, the DNEL should be adjusted by a factor of 100/39.8 to allow for this absorption profile i.e. adjusted DNEL = 0.263*(100/39.8) = 0.44 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Notrequired as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 4
- Justification:
- The duration of exposure in the key study providing the point of departure NOAEL was 36 days for male rats and 57 days for female rats. These exposure durations fall between the descriptors for subchronic (90 days) and subacute (28 days) in the guidance document. Since adaptive hepatotoxicity was observed in animals from this study, a modification to the exposure duration AF was made fro the conservative AF6 to AF4
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.263 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not applicable.
- AF for dose response relationship:
- 1
- Justification:
- Not required as the starting point is a NOAEL
- AF for differences in duration of exposure:
- 4
- Justification:
- The duration of exposure in the key study providing the point of departure NOAEL was 36 days for male rats and 57 days for female rats. These exposure durations fall between the descriptors for subchronic (90 days) and subacute (28 days) in the guidance document. Since adaptive hepatotoxicity was observed in animals from this study, a modification to the exposure duration AF was made fro the conservative AF6 to AF4
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Not required
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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 basis for the inhalation and dermal systemic DNELs for worker exposure to 2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl- is an oral subacute repeated dose toxicity study and reproductive toxicity screening study with the read-across substance, Nerolidol , from which the lowest NOAEL of 1500 ppm (equivalent to 105 mg/kg bw/day for F0 parental females) was identified. The NOAEL in parental males was identified as 4000 ppm (equivalent to 266 mg/kg/day). This study was of a prolonged duration (approximately 36 days in males and 57 days in females) and resulted in reduced body weight gains, reduced food intake and hepatotoxicity in males and females at the high dietary inclusion level of 12000 ppm and also in females treated with 4000 ppm. The lowest NOAEL (No Observed Adverse Effect Level) of 105 mg/kg bw/day was used as the basis of the DNEL calculations using appropriate assessment factors for relevant indicators including route to route extrapolation, allometric scaling, exposure duration and study length. For local effects it is considered that the systemic DNEL for inhalation exposure would be protective for this exposure in the absence of specific data. For dermal exposure the combination of acute dermal data and dermal absorption studies would indicate only a medium hazard.
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.