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EC number: 931-335-9
CAS number: 90622-74-5
For detailed tables kindly refer to the
attached background materials section of the IUCLID.
A study was conducted to evaluate the
long-term repeated dose dermal toxicity of the test substance, C8-18 and
C18-unsatd. DEA, in compliance with GLP. The experiment was conducted in
compliance with GLP. Groups of 50 male and 50 female rats were exposed
to 0, 50 or 100 mg/kg bw/day of the substance in ethanol by dermal
application, 5 times per week, for 104 weeks. Mortality, clinical signs
and bodyweight were recorded throughout the study. At necropsy, a gross
macroscopic examination and complete histopathology were carried out.
The survival rates of treated male and female rats were similar to those
of controls. There were no significant differences in bodyweight
throughout the groups. The only treatment-related clinical finding was
irritation of the skin at the site of application in 100 mg/kg bw/day
females. Non-neoplastic lesions of the skin at the site of application
included epidermal hyperplasia, sebaceous gland hyperplasia,
parakeratosis and hyperkeratosis, and the incidences and severities of
these lesions increased with increasing dose. There were marginal
increases in the incidences of renal tubule adenoma or carcinoma
(combined) in 50 mg/kg bw/day females. The severity of nephropathy
increased with increasing dose in female rats. The incidences of chronic
active inflammation, epithelial hyperplasia and epithelial ulcer of the
forestomach increased with dose in female rats and the increases were
significant in the 100 mg/kg bw/day group. Under the study conditions,
there was no evidence of carcinogenic activity of the test substance in
male rats at any dose. There was an equivocal evidence of carcinogenic
activity in female rats based on a marginal increase in the incidences
of renal tubule neoplasms. However, the absence of an increase in
neoplasms in the 100 mg/kg bw/day group in the presence of increased
hyperplasia makes the association with treatment uncertain. Under the
study conditions, the 2-yr NOAEL was considered to be 50 mg/kg bw/day in
rat (NTP, 2001).
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