Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

As actaldehyde is produced and used as an intermediate under industrial strictly controlled conditions only an occupational exposure limit is necessary. For Germany the MAK commission derived the offical occupational exposurelimit:

MAK-value= 50 ppm (91 mg/m3) (TRGS 900 2010, DFG 2008, AGS 2010).

Justification: Acetaldehyde has shown clastogenic, aneugenic and weak mutagenic activity. The observed nasal tumors coincided with cytotoxic effects at the nasal mucosea. As the irritating effects seem to play a major role for tumor formation, the occupational exposure limit (50 mL/m3) was primarily based by the "MAK Kommission" on the assumed no effect level for human sensory irritation. It was calculated from the NOAEC for respiratory tract irritation in the rat in a 4 week study (150 ml /m3) devided by three. The factor of three was evaluated from the database on formaldehyde that has a comparable mode of action regarding the irritation properties. Additionally, the "MAK Kommision" concluded that compliance with the occupational exposure limit would guarantee that the thereoff calculated liftime incremental charge with acetaldehyde (1.0 µmol / L blood) does not exeed the endogenous variation limit of acetaldehyde (endogenous level = 2,2 +/- 1.1 µmol/L; Fukunaga et al 1993). Based on this calculation and the fact that in animals no systemic tumors were observed at concentrations that caused local tumors it was not expected that exposure to acetaldehyde below 50 mL/m3 has a significant contribution to the lifetime cancer risk. Nevertheless it could not be completely excluded that genotoxic effects (DNA crosslinks and adducts) occur at these concentration locally in the nose. Regarding developmental toxicity the following calculation was made. Based on a NOAEL of 400 mg/kg bw per day from the most reliable study a NOAEC of 2800 mg/m3 (=1538 mL/m3) and 720 mg/m3 can be calculated according to the "MAK Kommision" (DFG 2008) and the "Ausschuß für Gefahrstoffe" (AGS 2010). As the margin of safety with regard to the MAK value is then around 30 and 8, respectively, both institutions concluded that the risk for developmental toxicity effects is adequatly controled by the MAK value.

Sources:

TRGS 900, Technische Regeln Gefahrstoffe, Bundesministerium für Arbeit und Soziales 2010, http://www.baua.de/cae/servlet/contentblob/666762/publicationFile/55588/TRGS-900.pdf

AGS, Ausschuß für Gefahrstoffe 2010, http://www.baua.de/cae/servlet/contentblob/879348/publicationFile/55468/900-acetaldehyd.pdf

DFG, Deutsche Forschungsgemeinschaft - MAK Kommision 2008

Fukunaga T, Sillanaukee P, Eriksson CJP (1993) Problems involved in the determination of endogenous acetaldehyde in human blood. Alcohol alcohol 28: 535-541

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

not relevant