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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
26.5 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):
10
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The conversion of the rat oral NOAEL of 150 mg/kg bw/day to a corrected inhalatory human NOAEC was based on the different respiratory volume of the rat (0.38 m³/kg) and the different rate during light activity at work (10 m³) and standard conditions (6.7 m³). Since alcohols are well absorbed after oral exposure, no additional factor for increased absorption after inhalation is deemed necessary.

AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
included in route to route extrapolation
AF for other interspecies differences:
1
Justification:
The NOAEL is mainly based on general toxicity (reduced body weight, food consumption). No additional differences are expected regarding these unspecific signs of toxicity.
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
NOAEL values and effects described are basically identical for the registered substance and the alcohols used for read across, including the study used as basis to derive the DNEL. Due to these similarities, no additional factor is considered necessary to account for uncertainties related to the read across approach.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
164 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
164 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 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):
40
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The absorption difference was assessed to 50 % comparing the dermal to the oral route. Accordingly, for dermal exposure the corrected starting point was calculated as 300 mg/kg body weight/day.

AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for rat to human
AF for other interspecies differences:
1
Justification:
The NOAEL is mainly based on general toxicity (reduced body weight, food consumption). No additional differences are expected regarding these unspecific signs of toxicity.
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
NOAEL values and effects described are basically identical for the registered substance and the alcohols used for read across, including the study used as basis to derive the DNEL. Due to these similarities, no additional factor is considered necessary to account for uncertainties related to the read across approach.
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 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):
20
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

The conversion of the rat oral NOAEL of 150 mg/kg bw/day to a corrected inhalatory human NOAEL was based on the different respiratory volume of the rat (1.15 m³/kg/day). Since alcohols are well absorbed after oral exposure, no additional factor for increased absorption after inhalation is deemed necessary.

AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
included in route to route extrapolation
AF for other interspecies differences:
1
Justification:
The NOAEL is mainly based on general toxicity (reduced body weight, food consumption). No additional differences are expected regarding these unspecific signs of toxicity.
AF for intraspecies differences:
10
Justification:
default factor for consumers
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
NOAEL values and effects described are basically identical for the registered substance and the alcohols used for read across, including the study used as basis to derive the DNEL. Due to these similarities, no additional factor is considered necessary to account for uncertainties related to the read across approach.
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:
3.75 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):
80
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The absorption difference was assessed to be 50 % comparing the dermal to the oral route. Accordingly, for dermal exposure the corrected starting point was calculated as 300 mg/kg body weight/day.

AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for rat to human
AF for other interspecies differences:
1
Justification:
The NOAEL is mainly based on general toxicity (reduced body weight, food consumption). No additional differences are expected regarding these unspecific signs of toxicity.
AF for intraspecies differences:
10
Justification:
default factor for consumers
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
NOAEL values and effects described are basically identical for the registered substance and the alcohols used for read across, including the study used as basis to derive the DNEL. Due to these similarities, no additional factor is considered necessary to account for uncertainties related to the read across approach.
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.9 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):
80
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

not needed

AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default factor for rat to human
AF for other interspecies differences:
1
Justification:
The NOAEL is mainly based on general toxicity (reduced body weight, food consumption). No additional differences are expected regarding these unspecific signs of toxicity.
AF for intraspecies differences:
10
Justification:
default factor for consumers
AF for the quality of the whole database:
1
Justification:
GLP guideline study
AF for remaining uncertainties:
1
Justification:
NOAEL values and effects described are basically identical for the registered substance and the alcohols used for read across, including the study used as basis to derive the DNEL. Due to these similarities, no additional factor is considered necessary to account for uncertainties related to the read across approach.
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