2022/06/29 by Hartwig, Andrea, MAK Commission
#1-Decanol #1-decanol #Analogiebetrachtung #Caprinalkohol #Decan-1-ol #Entwicklungstoxizität #Hauttumorpromotor #MAK value #MAK-Wert #Reizwirkung #Spitzenbegrenzung #Toxizität #caprinic alcohol #decan-1-ol #developmental toxicity #irritation #maximale Arbeitsplatzkonzentration #maximum workplace concentration #n-Decylalkohol #n-decyl alcohol #peak limitation #read-across #skin tumour promoter #toxicity
paper · doi:10.34865/mb11230kske7_2or
The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated 1-decanol [112-30-1112-30-1] to derive a maximum concentration at the workplace (MAK value), considering all toxicity end points. Critical effects are irritation and the tumour-promoting potential on the skin. Neither appropriate data in humans nor inhalation or oral studies of 1-decanol with animals are available for derivation of a MAK value. An 8-week feeding study in Wistar rats with the structurally related 1-dodecanol resulted in a NOAEL of 100 mg/kg body weight and day. The same NOAEL is assumed for 1-decanol. From this NOAEL, the concentration in workplace air was calculated according to the Commission’s procedure to be 245 mg 1-decanol/m3. However, as 1-decanol is irritating and there are no studies of effects in the respiratory tract, a comparison with structurally-related substances is indicated as well. The RD50 values of 45 ml/m3 and 50 ml/m3 for 2-ethylhexanol and 1-octanol, respectively, are rather similar, which can also be assumed for 1-decanol. Because of its similar irritating potency, the MAK value for 1-decanol has been established at 10 ml/m3 in analogy to 2-ethylhexanol. As local effects are critical, the substance is assigned to Peak Limitation Category I. The excursion factor of 2 is set in analogy to 2-ethylhexanol. From a synopsis of all data, 1-decanol is classified in Pregnancy Risk Group C, despite the small difference between MAK value and NOAEC of 15 ml/m3 for developmental toxicity. 1-Decanol is not mutagenic in bacteria. There are no long-term studies with 1-decanol. Papillomas, squamous cell carcinomas and severe skin irritation occurred after 60-week application to the skin of the mouse following initiation with 7,12-dimethylbenz[a]anthracene. The maximum skin absorption of 10 mg is less than 25% of the systemically tolerable amount of 660 mg which is taken up by inhalation at the MAK value. There are no positive clinical findings of contact sensitization from 1-decanol, nor are such effects expected from the structure and the comparison with homologous alcohols. Data for sensitization of the airways are not available.