Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.63 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Value:
47.48 mg/m³
AF for differences in duration of exposure:
2
Justification:
Correcting from a Subchronic to Chronic Study
AF for intraspecies differences:
3
Justification:
Account for differences in working population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.1 mg/m³
DNEL related information
DNEL derivation method:
other: EU-IOEL value (15 min STEL) adoption

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.1 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: EU-IOEL value (15 min STEL) adoption

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 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):
24
Modified dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
dermal absorpotion was conservatively assumed equivalent to oral absorption
AF for differences in duration of exposure:
2
Justification:
Subchronic to Chronic adjustment
AF for interspecies differences (allometric scaling):
4
Justification:
Rat allometric scaling factor
AF for intraspecies differences:
3
Justification:
Adjustment for worker response variability
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
7.2
Modified dose descriptor starting point:
NOAEL
AF for interspecies differences (allometric scaling):
2.4
Justification:
Rabbit allometric scaling factor
AF for intraspecies differences:
3
Justification:
Adjustment for worker response variability

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The EU IOEL value set for allyl alcohol is accepted as the correct DNEL value for short-term worker exposure: 15 minute inhalation STEL 12.1 mg/cu.m. For long-term worker exposure, calculated DNEL values are accepted (the long-term worker inhalation DNEL value thus calculated being marginally more conservative than the EU IOEL value).

General Population - Hazard via inhalation 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
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:
DNEL (Derived No Effect Level)
Value:
0.075 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
3 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat allometric scaling factor
AF for intraspecies differences:
5
Justification:
ECETOC general population assessment factor
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

No consumer uses are allowed as this is an intermediate chemical.