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EC number: 205-582-1
CAS number: 143-07-7
Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively.
Fatty acids are found in all living organisms fulfilling
fundamental physiological functions within the body. Based on this role
within the body no toxicity potential of fatty acids after repeated
exposure is expected as it could be demonstrated with C16 fatty acid
(lauric acid) and with C22 fatty acid (docosanoic acid), respectively.
The repeated dose toxicity of docosanoic acid was evaluated in a
combined repeated dose and reproductive/developmental toxicity screening
test performed under GLP according to OECD guideline 422 (Nagao et al,
2002). Groups of 13 male and 13 female Sprague-Dawley rats per dose
received daily doses of 100, 300 and 1000 mg/kg bw/d of docosanoic acid
by gavage. While the males were treated for 42 consecutive days, the
females received the test substance from 14 days prior to mating until
day 3 of lactation. As a result of this treatment, neither mortality nor
abnormalities in general condition were observed. In addition, no
changes in body weight, body weight gain and food consumption were found
in all dose groups. The observed minor changes in the corpuscular
hemoglobin concentration, glucose, chloride, calcium and alkaline
phosphate levels were regarded as incidental which also holds true for
the observed changes in liver weights in male and kidney weights in
females, respectively. All histological findings noted in all dose
groups were also detected in the control groups, so that all findings
could be regarded as not treatment-related. Overall, no
treatment-related adverse effects were apparent, so that the highest
administered dose of 1000 mg/kg bw/d is regarded as the NOAEL for
docosanoic acid under the experimental conditions of this study.
Repeated dose toxicity of lauric acid was analyzed in a study,
where 5 male Osborne-Mendel rats were fed a diet containing 10% lauric
acid for 18 weeks (Fitzhugh et al., 1960). As results, no clinical
effects, no adverse effects on weight gain nor any mortality was noted.
The performed gross organ pathology and did not reveal any significant
differences of individual organ weights between the controls and test
animals. Thus, the given dosage of 10% lauric acid in the diet is
regarded as the NOAEL, which corresponds to ca. 5000 mg/kg bw/d, based
on an average daily food consumption of 5 g/100 g bw.
In a third study which is insufficient for assessment due to
limited documentation, palmitic acid was adminstered to rats in the diet
for six weeks at a dose of 4600 mg/kg bw/d. According to the authors,
palmitic acid caused the hyperlipidemia (i.e. an excess of fats or
lipids in the blood). No further information was provided.
Taken together, the study data do not provide any evidence of
toxicity after repeated administration of fatty acids which is supported
by the physiological function of fatty acids within the body.
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification
criteria for repeated dose toxicity, fatty acids do not fulfill the
criteria for classification and thus a non-classification is warranted
for this endpoint.
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