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EC number: 203-838-7
CAS number: 111-14-8
One study is recorded for this endpoint (De Jouffrey, 1997). This
is a study which has evaluated the delayed contact hypersensitivity of
n-heptanoic acid using the maximization method of Magnusson and Kligman.
This study, conducted in compliance with the principles of Good
Laboratory Practice and according to OECD TG 406, was chosen as key
study. Results showed slight cutaneous reactions after the challenge
application in control and treated groups at the 24 and 48-hour reading.
After the microscopic examination, the cutaneous reactions observed in
both groups were attributed to slight irritant properties of the test
substance. Under the experimental conditions of this study, no cutaneous
reactions attributable to the sensitization potential of the test item
n-heptanoic acid (undiluted) were observed.
In a skin
sensitization test (CIT, 1997), the potential of n-Heptanoic acid
(batch No. 9604035) to induce delayed contact hypersensitivity was
evaluated in guinea pigs according to the maximization method of
Magnusson and Kligman OECD 406. Thirty animals were allocated to 2
groups: a control group 1 (5 males/ 5 females) and a treated group 2 (10
males/ 10 females). Skin reactions were evaluated approximatively 24 and
48h after removal of the dressing. At the end of the study animals were
killed without examination of internal organs (no necropsy). Skin
samples were taken from the posterior left and right flanks of all
animals and were preserved in 10 % buffered formalin.
No clinical signs and
no deaths were observedduring the study. The body weight gain of the
treated animals was normal when compared to that of the control animals.
On day 10, after the
cutaneous application of the induction period, signs of irritation were
observed at the test site (dorsal region between shoulders) in the
control and treated groups. After the cutaneous challenge application,
at the 24-hour reading, slight cutaneous reactions (very slight erythema
in 6/10 animals, dryness of the skin in 2/10 animals) were noted in the
control group. These reactions persisted at the 48-hour reading (very
slight erythema in 5/10 animals and dryness of the skin in all animals).
In the treated group,
the same cutaneous reactions were observed: very slight erythema in 6/20
animals at the 24-hour reading and in 5/20 animals at the 48-hour
reading, dryness of the skin in 8/20 animals at the 24-hour reading and
in all animals at the 48-hour reading. A well-defined erythema was also
noted in 1/20 animals at the 24-hour reading and crusts were observed in
1/20 animals at the 48-hour reading. After the microscopic examination,
the cutaneous reactions observed in both groups were attributed to
slight irritant properties of the test substance. The sensitivity of the
guinea-pigs was satisfactory since 50% of the animals showed a positive
reaction with DNCB.
the tested condition and according to the maximization method of
Magnusson and Kligman, the test substance n-Heptanoic
acid does not induce delayed contact hypersensitivity in guinea-pigs.
According to REGULATION (EC) No 1272 -2008:
Heptanoic acid is not sensitizing according to results obtained with a
standardized method in guinea pigs (OECD TG 406).
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