Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
120 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor:
NOAEC
Value:
1 500 mg/m³
AF for dose response relationship:
1
Justification:
There were no local effects in mice and male rats after 2 years of exposure to 1500mg/m³ isobutyraldehyde. Female rats showed mild metaplasia of the respiratory epithelium. Because the effects were slight and not dose-dependent, no further assessment factor is justified. Limited data from 15 male volunteers indicate that a concentration of 620mg/m³ is not irritating to the respiratory tract in humans. This supports the validity of the derived DNEL of 120mg/m³ and also supports the conclusion that no further assessment factor is required.
AF for differences in duration of exposure:
1
Justification:
The NOAEC was derived from a chronic study. Additionally, the local NOAEC after 90-days and 2 years was identical.
AF for interspecies differences (allometric scaling):
1
Justification:
not needed for local effects
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
several GLP studies in two species show comparable effects
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal 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

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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
Value:
1 500 mg/m³
AF for dose response relationship:
1
Justification:
There were no local effects in mice and male rats after 2 years of exposure to 1500mg/m³ isobutyraldehyde. Female rats showed mild metaplasia of the respiratory epithelium. Because the effects were slight and not dose-dependent, no further assessment factor is justified. Limited data from 15 male volunteers indicate that a concentration of 620mg/m³ is not irritating to the respiratory tract in humans. This supports the validity of the derived DNEL of 120mg/m³ and also supports the conclusion that no further assessment factor is required.
AF for differences in duration of exposure:
1
Justification:
The NOAEC was derived from a chronic study. Additionally, the local NOAEC after 90-days and 2 years was identical.
AF for interspecies differences (allometric scaling):
1
Justification:
not needed for local effects
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
10
Justification:
default factor
AF for the quality of the whole database:
1
Justification:
several GLP studies in two species show comparable effects
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
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

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

There are no consumer uses for this substance.