Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 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):
75
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL of 500 mg Tetrahydrolinalyl Acetate/kg bw/d is converted into inhalational NOAEC using the equation provided in the Guidance Document on Information Requirement, Chapter R8 and assuming that 100% of the applied dose is absorbed by inhalation. It is calculated to 881 mg/m3.


NOAEC = oral NOAEL*(1/(0.38 m3/kg/d))*(ABSoral rat/ABSinh human)*(6.7 m3(8h)/10 m3(8h)) 

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
This is taken into account in the calculation from NOAEL to NOAEC.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
5
Justification:
Standard factor for worker.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study
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:
13 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):
300
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 937 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The most relevant NOAEL for dermal DNELs is 500 mg/kg bw/d based on the combined 28-day repeated dose toxicity (OECD 422) study.

For Linalool, Green (2007) showed that most Linalool evaporates from the application side. In this study, human skin was exposed to radiolabeled Linalool for 24 hours, both open and occluded, in a 4 % (w/w) solution of ethanol/water (70:30). 12.7 % radioactivity were found in the receptor fluid when exposure was occluded.

As a consequence, using the equation provided in the Guidance Document on Information Requirement, Chapter R8 the corrected dermal NOAEL is 3937 mg Tetrahydrolinalyl Acetate/kg bw/d.


Corrected dermal NOAEL = oral NOAEL * (ABSoral rat/ABSderm human)

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
5
Justification:
Standard factor for worker.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study.
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

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:
2.8 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):
150
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL of 500 mgTetrahydrolinalylAcetate/kg bw/d is converted into inhalational NOAEC using the equation provided in the Guidance Document on Information Requirements, Chapter R8 assuming that 100 % of the applied dose is absorbed by inhalation. It is calculated to 434 mg/m3.


NOAEC = oral NOAEL*(1/(1.15 m3/kg/d))*(ABSoral rat/ABSinh human)

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
This is taken into account in the calculation from NOAEL to NOAEC.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study
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:
6.5 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):
600
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 937 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The most relevant NOAEL for dermal DNELs is 500 mg/kg bw/d based on the combined 28-day repeated dose toxicity (OECD 422) study.

For Linalool, Green (2007) showed that most Linalool evaporates from the application side. In this study, human skin was exposed to radiolabeled Linalool for 24 hours, both open and occluded, in a 4 % (w/w) solution of ethanol/water (70:30). 12.7 % radioactivity were found in the receptor fluid when exposure was occluded.

As a consequence, using the equation provided in the Guidance Document on Information Requirement, Chapter R8 the corrected dermal NOAEL is 3937 mg Tetrahydrolinalyl Acetate/kg bw/d.


Corrected dermal NOAEL = oral NOAEL * (ABSoral rat/ABSderm human)

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from a reliable repeated dose toxicity study.
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 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:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The most relevant NOAEL for oral DNELs is 500 mg/kg bw/d determined in a combined 28-day repeated dose toxicity (OECD 422) study.

AF for dose response relationship:
1
Justification:
No assessment factor is needed as a NOAEL was used as starting dose descriptor.
AF for differences in duration of exposure:
6
Justification:
Standard factor for scaling of subacute to chronic duration of the study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor.
AF for other interspecies differences:
2.5
Justification:
Standard factor.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
DNEL is derived from reliable repeated dose toxicity study.
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:
low hazard (no threshold derived)

Additional information - General Population