Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
103 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC technical report no. 86
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEC
Value:
1 230 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC from rat subchronic inhlation study = 1230 mg/m3 (Bushy run 1992, European Union Risk Assessment Report, propan-1-ol, 2008)

 

Modification of the dose descriptor according to ECHA Guidance R.8

Corrected inhalatory NOAEC = inhalatory NOAEC * (exp.time rat/exp.time worker) * (ABS rat/ABS human) * (sRVhuman 8h/wRV)

ABS – absorption (assumed 100% in human and in experimental animamals)

sRVhuman – respiratory volume under standard conditions

wRV – respiratory volume light activity for worker

 

Corrected NOAEC = 1230 mg/m3 * ( 6 h/d / 8 h/d) * (100/100) * (6.7 m3/ 10 m3) = 618.1 mg/m3

 

Assessment factors – based on ECETOC (2003) technical report no. 86

Intraspecies difference for worker = 3

exposure duration subchronic to chronic = 2

Overall AF = 3*2 = 6

DNEL worker systemic effects by inhalation = 618.1 / 6 = 103 mg/m3

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The substance is classified for eye damage category 1 and skin irritation category 2 and STOT SE 3 (drowsiness); moderate hazard is assigned according to ECHA CSA guidance Part E Table E 3-1. Risk characterisation is conducted qualitatively.

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

None.

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:
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:
no hazard identified

Additional information - General Population

None.