Registration Dossier
Registration Dossier
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EC number: 259-461-3 | CAS number: 55066-48-3
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.88 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x 25/100 = 75 mg/kg); NOAEL(oral) converted to NOAEC(inhal) (75 mg/kg x [1/0.38 x 100/100 x 6.7/10]) = 132 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:
- 6
- Justification:
- Extrapolation from subacute 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 determination of dose descriptor starting point
- Justification:
- Differences in species addressed in determination 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 data on the substance itself with regards to developmental and reprotoxicity
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 5.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x 25/100 = 75 mg/kg); NOAEL(oral) converted to NOAEC(inhal) (75 mg/kg x [1/0.38 x 100/100 x 6.7/10]) = 132 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
- Justification:
- Differences in species addressed in determination of dose descriptor starting point
- Justification:
- Differences in species addressed in determination 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 data on the substance itself with regards to developmental and reprotoxicity
- 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
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:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 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:
- 6
- Justification:
- Extrapolation from subacute 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 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 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: NOEL
- 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
- Justification:
- Not required
- AF for interspecies differences (allometric scaling):
- 6
- Justification:
- Extrapolation from subacute 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:
- Not required
- 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:
- 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 remaining uncertainties:
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
3 -methyl-5-phenylpentanol did not show any relevant inhalatory local effects and so a DNEL for inhalation local effects is not required. The substance is classified as a skin irritant and so DNELs have been calculated for dermal local effects.
Based on the results of in vitro and in vivo studies, 3-methyl-5-phenylpentanol is considered not to possess any genotoxic potential.
Scortichini et al (1987) was performed to a method equivalent to OECD 414. The study selected the rabbit as the test system, as it is known to be the most sensitive to this group of chemicals. 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 2, as the study was performed on a read-across substance. Under the conditions of the test, the test material 2-phenoxyethanol was found not to exhibit foetal toxicity up to 600 mg/kg bw/day, at a level which was found to be maternally toxic. The maternal toxicity NOAEL from this study was determined to be 300 mg/kg bw/day and this value was used as the starting point for the calculation of the systemic DNELs.
For the purposes of human risk assessment there is sufficient information to consider that 3-methyl-5-phenylpentanol would be rapidly and completely absorbed, completely metabolised to amino acid conjugates, and excreted within 24 hours of oral administration. Human dermal absorption may be considered to be 25%; 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:
- 0.21 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x 25/100 = 75 mg/kg); NOAEL(oral) converted to NOAEC(inhal) (75 mg/kg x [1/1.15 x 100/100) = 65 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:
- 6
- Justification:
- Extrapolation from subacute 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 determination of dose descriptor starting point
- Justification:
- Differences in species addressed in determination 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 data on the substance itself with regards to developmental and reprotoxicity
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.3 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x 25/100 = 75 mg/kg); NOAEL(oral) converted to NOAEC(inhal) (75 mg/kg x [1/1.15 x 100/100) = 65 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- efault value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- Justification:
- Differences in species addressed in determination of dose descriptor starting point
- Justification:
- Differences in species addressed in determination 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 data on the substance itself with regards to developmental and reprotoxicity
- 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
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:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- efault 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:
- 6
- Justification:
- Extrapolation from subacute 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- efault 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 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.065 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor:
- other: NOEL
- 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:
- 6
- Justification:
- Extrapolation from subacute 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:
- Not required
- Justification:
- Not required
- 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:
- 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 remaining uncertainties:
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.39 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: NOAEL
- 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
- Justification:
- Not required
- Justification:
- Not required
- 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
- Justification:
- Not required
- AF for remaining uncertainties:
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x (25/100) = 75 mg/kg)
- 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:
- 6
- Justification:
- Extrapolation from subacute 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.375 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- NOAEL(dermal) converted to NOAEL(oral) (300 mg/kg x (25/100) = 75 mg/kg)
- 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 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:
- Not required
- 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 data on the substance itself with regards to developmental and reprotoxicity
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The same end point used for workers has been chosen for the setting of the long term DNELs for the 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.
