Registration Dossier
Registration Dossier
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EC number: 277-923-2 | CAS number: 74563-64-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point correction formula:
corrected dermal NOAEL = oral NOAEL x Diff. exp. cond. x (ABSoral, al / ABSderm, hu)
= 150 mg/kg bw/day x 1 x 16.67 = 2500 mg/kg bw/day
Relevant human exposure route : Dermal
ABSoral, an / ABSdermal, hu : 16.67
Experimental animal : rat
Differences experimental/human exposure conditions: 1
Bioavailability of phytantriol was assessed in a dermal penetration study with radiolabelled test item in pig skin. The amount of phytantriol in epidermis, dermis and receptor fluid (evaluated all together) after 18 h administration was between 1.0 - 5.4%, dependent on the vehicle used. For the DNEL derivation, a conservative value of 6% bioavailability was used for modification of oral to dermal result.
- AF for dose response relationship:
- 2
- Justification:
- Starting result is NOAEL from OECD 422 study. An additional assessment factor of 2 was added for lower sensitivity of the OECD 422 study.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for sub-acute studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- No additional AF considered necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AF considered necessary.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 0.185 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 55.56 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point correction formula:
corrected inhalation NOAEC = oral NOAEL x 1/sRVan x Diff. exp. cond. x (ABSoral, an / ABSinh, hu)
= 150 mg/kg bw/day x 0.74 mg3 kg bw x 0.5 = 55.56 mg/m3
Relevant human exposure route : Inhalation
ABSoral, an / ABSinh, hu : 0.5
Experimental animal : rat
Standard respiratory volume, animal (sRVan) : 1.35 mg3 kg bw (24 h)
Differences experimental/human exposure conditions : 1
- AF for dose response relationship:
- 2
- Justification:
- Starting result is NOAEL from OECD 422 study. An additional assessment factor of 2 was added for lower sensitivity of the OECD 422 study.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute studies.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not necessary as differences in allometry accounted for in modification of oral to inhalation starting dose.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- No additional AF considered necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AF considered necessary.
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:
- 2.08 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point correction formula:
corrected dermal NOAEL = oral NOAEL x Diff. exp. cond. x (ABSoral, al / ABSderm, hu)
= 150 mg/kg bw/day x 1 x 16.67 = 2500 mg/kg bw/day
Relevant human exposure route : Dermal
ABSoral, an / ABSdermal, hu : 16.67
Experimental animal : rat
Differences experimental/human exposure conditions: 1
Bioavailability of phytantriol was assessed in a dermal penetration study with radiolabelled test item in pig skin. The amount of phytantriol in epidermis, dermis and receptor fluid (evaluated all together) after 18 h administration was between 1.0 - 5.4%, dependent on the vehicle used. For the DNEL derivation, a conservative value of 6% bioavailability was used for modification of oral to dermal result.
- AF for dose response relationship:
- 2
- Justification:
- Starting result is NOAEL from OECD 422 study. An additional assessment factor of 2 was added for lower sensitivity of the OECD 422 study.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- No additional AF considered necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AF considered necessary.
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:
- no hazard 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
DNELs have been assessed for the general population. However, these are for reference only. The only consumer use of the substance is in use of cosmetics and personal care products, which will be assessed under the Cosmetics Directive (76/768/EEC), which addresses the assessment of cosmetic products’ safety for human health.
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.
