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EC number: 701-068-0
CAS number: 2156592-58-2
Octadecenylamine (oleylamine) was dermally applied on two 5-days
periods with intermediate 2-day non dosing-period to male and female
Sprague-Dawley rats (Intox Laboratories, 1985). Animals of the control
groups received the vehicle only (mineral oil).
Based on the results of a pilot study, groups of young adult rats
(4 males and 4 females) were treated dermally with the test substance at
concentrations of 0, 0.3, 1.5 and 3.0% (v/v) in mineral oil
(corresponding to doses of 0, 12.5, 62.5 and 125 mg/kg bw/d). Rats were
treated for two five-day dosing periods with an intermediate two-day
non-dosing period in order to more closely reproduce conditions of human
exposure to the test substance. The first day of dosing was designated
as Day 1. Due to excessive tissue destruction indicated by sloughing,
scores of moderate to severe erythema, scabbing, hardening of the skin,
and sensitivity to touch, the dosing at the intermediate and high dose
levels (1.5 and 3.0%) was discontinued on Day 9. These animals were
subsequently sacrificed on Day 10. At initiation of dosing the rats’
body weights ranged from 205.7 to 321.3 g. Rats were acclimated to the
laboratory for seven days prior to test substance application. Water and
food were provided ad libitum. Approximately 24 hours prior to test
substance application, the fur was clipped from the dorsal area of each
animal. Shaving was repeated one week later. The test substance was
applied at a volume dosage of 5 ml/kg. The application site was covered
by a porous gauze dressing that was held in place with tape, and covered
with a taped elastic bandage. Each day, wrappings were removed
approximately six hours after test substance application and the test
sites were washed with warm water to remove excess test substance.
Observations of signs of toxicity were made once each day. Body weights
were recorded during acclimation, weekly during the study and at
sacrifice. Food consumption was recorded weekly during the study.
Morbidity/mortality checks were examined prior to test substance
administration on days 2, 4, 6, 8, 10, 12 and 14 for signs of erythema
and necropsies were performed. Animals were killed and discarded three
days following the completion of dosing.
All rats survived until scheduled sacrifice. Concentrations of 1.5
and 3.0% produced moderate to severe irritation (erythema scores 2-4),
which in some instances progressed to hardening and sloughing of the
skin. A number of rats were sensitive to touch. In the 0.3 % group,
erythema scores of 1 to 2 were observed, indicating mild to moderate
irritation, and flaking of the outer layers of the epidermis was
observed. An increased sensitivity in females to the irritant effects of
the test substance as compared to males was observed. In the control
group, one male showed an erythema score of 1 at one observation. All
rats in the 1.5 and 3% groups were sacrificed on day 9 of the study due
to the irritant/corrosive effects of the test substance. No other
treatment-related irritant effects or clinical signs were observed. A
significant treatment-related effect on body weight was observed for
males at day 7. Individual group comparisons revealed that body weights
in both the 1.5 and 3% groups were significantly lower than controls.
Females in the 3.0% group showed a mean weight loss during the first
week of the study, although this finding was not significant. Food
consumption during the first week of study was reduced significantly in
the 1.5% group males when expressed as total food consumed. No
significant difference was noted when expressed on a per weight basis.
The study provides additional data on the toxicity of repeated dermal
dosing, including severe irritation, of this test substance at
concentrations of 0.3, 1.5 and 3.0%. A NOAEL for local dermal effects
could not be derived, the LOAEL was 0.3% (v/v). No NOAEL for systemic
toxicity was derivable because of lack of histomorphology data from
other organs and tissues.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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