Registration Dossier
Registration Dossier
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EC number: 203-562-7 | CAS number: 108-22-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 42 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 42 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 mg/kg bw/day
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Isopropenyl acetate caused in a valid 28 days inhalation study in the lowest concentration tested (50 ml/m3= 207,5 mg/m3) in the front parts of the nasal cavity (level 1) minimal to slight focal to multifocal inflammatory cell infiltration in 2 of 5 rats. 200 ml/m3was the NOAEC for broader irritating effects like hyperplasia of the nasal transition epithelium and degeneration of the olfactory epithelium, which were detected in the highest dose group tested of 500 ml/m3. In a 5 days dose range finder study the lowest concentration of 200 ml/m3did not show any irritating effects. Minimal inflammatory cell infiltrates also occurred in level 1 of the nasal cavity in one male and one female animal of the control group of the 28 days study. The effects observed in the low dose group can therefore be seen as of minimal intensity. The MAK value is therefore been set to 10 ml/m3(42 mg/m3). As no systemic effects were observed in the highest dose group of 200 ml/m3no systemic effects have to be anticipated. [MAK value justification, 2004].
This value is also supported by the German OEL (ARW) of 10 ml/m3(42 mg/m3) issued by the Committee on Hazardous Substances (AGS) in 2006.
DNEL longtime dermal:
If the respiratory rate (8 hour) of a worker is assumed to be 10 m3/person with a body weight of 70 kg the corrected NOAEL(dermal) is therefore: = 42 mg/m3* 10 m3/70 kg = 6 mg/kg bw/day (8 hour day) .
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
As there is no use with consumer contact no DNELs were derived for the genearl population.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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