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EC number: 202-859-9 | CAS number: 100-51-6
In a 13 week dose-finding study male and female rats received daily up to 800 mg/kg bw benzyl alcohol. The NOAEL was considered to be 400 mg/kg bw/daybased on signs of neurotoxicity, reduced body weight development and histopathological effects mainly in the brain at next higher dose (800 mg/kg bw/day)(NTP 1989). This NOAEL was confirmed in a 2 year study (carcinogenicity study).In a 13 week dose-finding study male and female mice received daily up to 800 mg/kg bw benzyl alcohol. The NOEL was considered to be 200 mg/kg bw/day. At 400 mg/kg a slight decreased body weight gain was reported and at 800 mg/kg additionally staggering after dosing during the first and second weeks of the studies was observed. No compound-related histopathological effects were found in the mice study, indicating adaptive response to the compound and no adverse effect at 400 or 800 mg/kg. This NOEL was confirmed in a 2 year study (carcinogenicity study).In a subacute inhalation toxicity study according to OECD TG 412, male and female rats were exposed nose-only to benzyl alcohol at mean analytical exposure concentrations up to 1072 mg/m³ air for 6 hour/day, 5 day/week for 4 weeks. The NOAEL was concluded to be 1072 mg/m³ based based on the fact that the exposure was tolerated without adverse effects up to and including this test substance concentration (Roper 2010).
Cited from abstact of NTP report: "No apparent compound-related non-neoplastic responses were observed."
In a study equivalent to OECD TG 451 (supervised by NTP) male and female F344/N rats received daily by gavage 0, 200 and 400 mg/kg bw/day benzyl alcohol diluted in corn oil for 104 weeks (5 days/week). No effect on body weight gain and and no compound-related clinical signs were observed throughout the study. Survival was reduce only for female rats, but in many cases deaths were attributed the gavage procedure. Gross necropsy and histopathology revealed no apparent compound-related non-neoplastic responses. Thus, 400 mg/kg can be considered a NOAEL from this study (NTP TR 343, 1989).
In a study according to OECD TG 412 aerosolized benzyl alcohol was administered via nose-only inhalation for 6 hours per day on a 5-day/week basis for a period of 4 weeks (a minimum of 20 exposures/animal) to 4 groups (Groups 2-5) of Sprague-Dawley rats. Target exposure concentrations were 30, 100, 300, and 1000 mg/m³ for Groups 2, 3, 4, and 5, respectively. A concurrent control group (Group 1) was exposed to filtered air on a comparable regimen. Each group consisted of 10 animals/sex. All animals were euthanized on the day following the last exposure.
Based on the results of this study, repeated inhalation exposure of male and female rats to benzyl alcohol at mean analytical concentrations of 41, 102, 290 and 1072 mg/m³ was well-tolerated with no adverse effects at any exposure concentration. The
no-observed-adverse-effect concentration (NOAEC) was considered to be 1072 mg/m³.
There are subchronic and chronic studies available which were conducted within the US NTP programme (NTP 1989). They do not fully comply with the current respective guidelines due to the lack of clinical chemistry data, hematology data, and urinalysis data. Instead, clinical signs, body weight development and extensive gross and histopathology examinations were performed. The studies were assessed as of high quality, since they were peer-reviewed by a panel nominated by the US NTP.
In the 13 week dose-finding study male and female rats received daily 0, 50, 100, 200, 400, 800 mg/kg bw/day benzyl alcohol by gavage. At 800 mg/kg clinical signs of neurotoxicity including staggering, laboured breathing, and lethargy were reported; additionally reduced body weight development and histopathological changes mainly in the brain. The NOAEL was concluded therefore 400 mg/kg bw/day (NTP 1989).
The respective 13 week dose-finding study in male and female mice revealed no compound-related adverse effects up to the highest dose of 800 mg/kg. Only staggering after dosing during the first and second weeks and reduced body weight development were reported. No compound-related histopathologic effects were observed. The NOEL was considered 200 mg/kg bw/day (NTP 1989).
In the consecutive chronic studies (studies on carcinogenicity; NTP 1989), rats and mice received by gavage 0, 200, 400 mg/kg bw/day and 0, 100, 200 mg/kg bw/day, respectively. The exposure was well tolerated and the NOAELs of the subchronic studies were confirmed: NOAEL rats 400 mg/kg bw/day; NOEL mice 200 mg/kg bw/day (highest dose tested). This provides evidence that for benzyl alcohol toxicity is not depending on the duration of exposure.
(For the assessment of carcinogenic effects see the chapter on carcinogenicity.)
No studies available.
There is no subchronic study with inhalation exposure available.
In a subacute inhalation toxicity study according to OECD TG 412 male and female rats were nose-only exposed to concentrations of up to 1072 mg/m³ aerosolised benzyl alcohol. The exposure regimen was 6 hours/day, 5 days/week for 4 weeks (minimum of 20 exposures). The aerosol was of good respirability for the rats.
In this study exposure was tolerated without adverse effects up to the highest concentration of 1072 mg/m³, leading to a NOAEC of 1072 mg/m³.
Moreover, the low inhalation toxicity indicated that the NOAEC obtained is not more sensitive than the NOAEL derived from the repeated oral toxicity studies. (Roper 2010)
According to legal classification (Directive 67/548/EEC and Regulation (EC) No. 1272/2008) benzyl alcohol is not classified for repeated dose toxicity.
Based on the available data and according to criteria of Regulation (EC) No. 1272/2008, Annex I, classification for repeated dose toxicity would not be justified.
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