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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
98.7 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
1 230 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
1
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
5
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
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:
35.26 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):
25
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
88.16 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
881.58 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
88.16 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
5
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

4-methyl-3-decen-5-ol is not classified for acute toxicity, skin/eye irritation or skin sensitisation and is not expected to show any local effects; DNELs for acute exposure and local effects were therefore not calculated. The substance does not possess any genotoxic potential.

The reproductive and developmental toxicity of the test material was investigated in a study performed in accordance with standardised guidelines OECD 421 and EPA OPPTS 870.3550 using an appropriate test material suitable for read-across to support 4-methyl-3-decen-5-ol. 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 study, the NOAEL for reproductive performance and fertility was determined to be 300 mg/kg bw/day and this value was used as the starting point for the calculation of systemic DNELs.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.38 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):
25
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
1
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
10
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
AF for remaining uncertainties:
2
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:
8.7 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.74 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.74 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
89.3 µg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
10
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
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 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for differences in duration of exposure:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor starting point:
NOAEC
Value:
435 mg/m³
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
1
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL generation plugin)

AF for dose response relationship:
1
Justification:
Default (DNEL generation plugin)
AF for differences in duration of exposure:
1
Justification:
Default (DNEL generation plugin)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL generation plugin)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL generation plugin)
AF for intraspecies differences:
10
Justification:
Default (DNEL generation plugin)
AF for the quality of the whole database:
1
Justification:
Default (DNEL generation plugin)
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 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default ECHA assessment
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA assessment
AF for other interspecies differences:
2.5
Justification:
Default ECHA assessment
AF for intraspecies differences:
10
Justification:
Default ECHA assessment
AF for the quality of the whole database:
2
Justification:
Read-across
AF for remaining uncertainties:
1
Justification:
Default ECHA assessment

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

4-methyl-3-decen-5-ol is not classified for acute toxicity, skin/eye irritation or skin sensitisation and is not expected to show any local effects; DNELs for acute exposure and local effects were therefore not calculated. The substance does not possess any genotoxic potential.

The reproductive and developmental toxicity of the test material was investigated in a study performed in accordance with standardised guidelines OECD 421 and EPA OPPTS 870.3550 using an appropriate test material suitable for read-across to support 4-methyl-3-decen-5-ol. 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 study, the NOAEL for reproductive performance and fertility was determined to be 300 mg/kg bw/day and this value was used as the starting point for the calculation of systemic DNELs.