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EC number: 240-367-6
CAS number: 16260-09-6
Skin irritation (OECD 404): not irritatingEye irritation (OECD 405): not irritating
The skin irritation potential of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) was investigated in a GLP-compliant study performed
according to OECD 404 (Notox C.V., 1986). The shaved skin of 3 female
New Zealand White rabbits was exposed to test substance moistened with
0.5 mL water for 4 h under semi-occlusive conditions. The skin of the
contralateral flank remained untreated and served as control. Evaluation
of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h
after removal of the dressing. At the 1 h reading time point, 2 animals
showed slight erythema which was fully reversible within the following
24 h. No further dermal effects were observed in any of the animals at
the remaining reading time points. The mean erythema and edema scores
after 24, 48 and 72 h were 0 for each individual animal. Based on these
results, the test substance was not considered to be irritating to skin.
An eye irritation study performed in compliance with OECD 405 and GLP is
available for (Z)-N-octadec-9-enylhexadecan-1-amide (CAS 16260-09-6)
(Notox C.V., 1986). The undiluted test material (90 mg equivalent to ca.
0.1 mL) was placed into the conjunctival sac of one eye of 3 female New
Zealand White rabbits each. The other eye remained untreated and served
as control. The eyes were examined and scored 100 min, 24, 48 and 72 h
as well as 7 and 14 days after test substance application. At the first
observation time (100 min after instillation), hyperaemia of the blood
vessels of the conjunctivae, affecting the eye lids and the scleral
conjunctivae, was observed in all animals, as well as obvious swelling
of the eyelids. Increased lacrimation was also observed in all animals
at this time. Treatment of the eyes with fluorescein 24 h after
substance installation revealed 20-25% corneal epithelial damage, which
was fully reversible 3 days after treatment. At the 24 h reading time
point, injection of the capillaries in the iris was observed in all
animals, as well as deepened rugae in 1/3 animals; but in all animals
the iris still reacted to light. In the animal with the deepened rugae,
the iris effects disappeared within the next 24 h, while in the other 2
animals the injection of capillaries was still present at the 48 and 72
h reading time point. Slight conjunctival swelling persisted in all
animals until 72 h after treatment, while slight redness was still
observable on Day 7 of the observation period. Fourteen days after
treatment, all adverse ocular effects had fully disappeared in the
animals. The mean iris, conjunctivae and chemosis scores of the reading
time points 24, 48 and 72 h were 0.3/0.7/1, 1.3/2/1.7 and 1.3/1.3/1.3
for the 3 individual animals, respectively. For cornea, the mean score
was 0 in each individual animal at the 24, 48 and 72 h reading time
points. Therefore, the test substance does not have to be considered as
irritating to the eye.
The available data on skin and eye irritation of (Z)-N-octadec-9-enylhexadecan-1-amide
(CAS 16260-09-6) do not meet the criteria for classification according
to Regulation (EC) No 1272/2008 and are therefore conclusive but not
sufficient for classification.
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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