Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

BASF SE reported a 28d study which was performed within a reproductive toxicity screening according to OECD 422 under GLP (BASF SE, 2013). Here, 4-Hydroxyacetophenone was administered by daily oral gavage to male and female Wistar Han rats. Applied doses were 40, 150 and 600 mg/kg bw/day, determined in a range-finding study. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 30 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 43-46 days). Salivation was seen after dosing of 600 mg/kg bw/day which was considered to be a physiological response to taste of the test substance. No toxicologically significant changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical pathology investigations, macroscopic examination, organ weights, and microscopic examination). Based on these results, a No Observed Adverse Effect Level (NOAEL) of at least 600 mg/kg bw/day was derived.


Biodynamics (1986) reported a 3-month oral toxicity study in rats. Male and female Sprague-Dawley rats were administered (gavage) concentrations of 5, 15 or 45 mg/kg (dissolved in corn oil). The following results were recorded: One mid-dose treated female was sacrificed moribund on Test-Day 57. A control male was found dead on Test Day 12. A total of 7 other animals distributed across the groups were considered accidental deaths. These animals showed evidence of intubation trauma and their deaths were not considered treatment-related. Physical observations noted in the treated males and females were of the type commonly seen in laboratory rats and did not appear to be treatment-related. Several (1-3) male animals in the control and most treated groups exhibited chromodacryorrhea, and/or lacrimation at one or more observation intervals. These findings were not considered treatment-related. There were no findings noted at the terminal ophthalomoscopic examination which were considered treatment-related. The mean body weights of the males and females in all treated groups were comparable to or slightly exceeded their respective corresponding control values. There were no indications of treatment-related effects in any of the mean body weight data. Mean food consumption values were slightly elevated in the high-dose-group males during the later weeks of the study (Weeks 8-12). A similar effect was not evident in the high-dose treated females. While in some cases the increased food consumption values noted in the treated animals were statistically significant, the increases were slight, were generally not dose-related and were not considered indicative of significant toxicity. Hematology: There was a suggestion from this study that the test substance may have a similar effect at higher doses than were employed in this study. There was a dose-related increase in reticulocytes in males and females but no statistically significant differences were recorded. No trends occurred at month 3 in either sex in animals given the test substance. It is concluded that administration of up to 45 mg/kg/day produced no significant effects. Urinalysis data for the treated male and female rats were unremarkable. There were no findings which were suggestive of a treatment-related response. Pathology: There were no treatment-related effects noted in the tissues examined. A NOAEL of 45 mg/kg for male and female animals was reported.

Biodynamics (1990) reported a 4-week inhalation toxicity study. Male Sprague-Dawley rats were offered a dust concentration of 42 mg/m3 for 6 hours/day and 5 days/week. The only deviation observed was a significant decrease of albumin after the 1st week of exposure. After 4 weeks, the albumin values had returned to normal. This finding was considered of unclear toxicological significance. The exposure of 42 mg/m3 did not lead to mortalities nor to any other treatment-related findings after 28 days. Thus, this dose level can be considered as a NOAEC.

Justification for classification or non-classification

Based on the available data, classification is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.