Registration Dossier

Administrative data

Description of key information

Sensitisation data
The test substance itself as well as other category members were found to not be skin sensitising.
Exposure related observations
The nasal pungency threshold of the test substance was found to be 5.86 mg/L.
A member of the category was found to be irritating to the throat at a concentration of 0.366 mg/L.
The test substance was not irritating to the skin of 30 human volunteers.

Additional information

Sensitisation data (humans)

Data are available obtained in a human maximization test conducted with 3-methylbutan-1-ol (Kligman 1976). In this study, the sensitization to skin was evaluated in 25 human volunteers, who received an application of 8 % 3-methylbutan-1-ol in a 2.5 % aqueous sodium lauryl sulfate solution. The substance was applied via an occlusive patch test to the same site on the volar forearm or back of all subjects for five alternate-day 48 hour periods. Evaluation of the skin sites revealed that none of the 25 individuals showed any signs of sensitization.

Furthermore, publications are available describing the sensitisation potential of the test substance itself. These studies were included for completeness sake, but are not considered reliable. In an epicutaneous patch test (Fregert 1963), one dermatitiis patient reacted to pentan-1 -ol at a concentration of 10 %, but the chromatogram of the test substance showed 11 additional peaks, so the cause for the reaction is unclear. In another publication, four patients also exhibiting dermatitis were tested positive for pentan-1 -ol (Fregert 1969). A further test person who showed positive skin reactions towards hair lotions was exposed to a series of lower aliphatic alcohols did not react to pentan-1 -ol in an epicutaneous patch test (Ludwig 1977). It should be noted that all patients with positive reactions to pentanol also reacted to all other tested lower primary alcohols. From the provided anamnesis data it can be concluded that pentanol was an unlikely inducer of the sensitzisation. Definite cross sensitization was observed in the publication by Stotts (1977). One patient had previously been sensitized against ethanol due to his voluntary participation in a human patch testing procedure. The other person was sensitized against acetaldehyde while undergoing testing for the maximum non-irritant concentration of this substance. During subsequent patch testing, both also reacted to pentanol, but also to all other tested primary alcohols.

Exposure related observations in humans: other data

In a publication (Cometto-Muniz 1990) a study is described which was conducted to assess the odor threshold of 11 chemicals including the test substance. The detection thresholds were measured repeatedly in normosmic and anosmic subjects. The stimuli comprised the first eight members of the series of n-aliphatic alcohols, phenyl ethyl alcohol, pyridine, and menthol. The anosmic subjects were: one male (39 -years-old, nonsmoker, congenital anosmic) and two females (a 35-year-old, nonsmoker, head-trauma anosmic and a 20-year-old, smoker, congenital anosmic).Sessions typically lasted between two and four hours, and they were repeated until 12 thresholds.Recalculation of vapour concentration was performed according to the formula: C (mg/m3) = (molecular weight (g) * C (ppm)) / 24.1 L at 20°C and 1013 hPa (DFG, MAK-Liste).The test substance was detected by all subjects. The average nasal pungency threshold was found to be (± SD): 1603 ± 1.2 ppm equivalent to 5.86 mg/L.

In a further publication (Nelson 1943) the irritant property of another category member to the throat was investigated. The concentration at which the vapour caused irritation to the throat was determined to be 100 ppm (corresponding to 0.366 mg/L).

Furthermore, a study report is available evaluating the potential of the test substance to induce skin irritation.30 human volunteers was used to apply 0.2 mL of pentan-1-ol on a 25 mm plain Hill Top Chamber containing a Webril pad to the skin of the upper outer arm (Basketter et al. 2004). After an application of 15 and 30 minutes through 1, 2, 3 and 4 hours, pentan-1-ol was found to be not irritating to skin.

One poisoning incident is available for 2 -Metyhyl-1 -Butanol. A 28 year-old male was found in a deep coma complicated with acute respiratory failure because of recreational intoxication. In the case described, the patient ingested an unknown amount of 2 -Metyhyl-1 -Butanol (99% purity) from a 250 mL bottle. The ingestion in a single dose corresponding to the whole volume of the bottle would be equal to 3 g/kg bw (Anand et al. 2014).