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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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