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EC number: -
CAS number: -
Skin irritation (OECD 404): not irritating Eye irritation (OECD 405): not irritating
Erythema and edema scores at 1, 24, 48 and 72 hours were 0 for each of
the three animals tested.
The individually determined mean irritation scores for each animal for
corneal opacity, iris lesion, conjunctival redness and conjunctival
chemosis for the 24, 48 and 72-hour intervals are:
The acute dermal irritation study in New Zealand White Rabbits was
conducted to evaluate the skin irritation potential of the test
substance according to OECD guideline 404 and under GLP conditions
(Prakash, 2011). Five hundred mg (0.5 g) of the test substance was made
into a paste with sufficient volume of water and mixed with a glass rod
and was applied to the dose site and covered with a gauze pad of size
approximately 6 cm² (2 x 3 cm-6ply). The patches were secured to the
body of the animal by a non-irritating semi-occlusive adhesive tape.
After 4 hours contact period the bandage was removed and the dose sites
were wiped with water. The degree of irritation was evaluated and scored
by Draize’s evaluation method at 1, 24, 48 and 72 hours post removal of
the test patch. Erythema and edema scores at 1, 24, 48 and 72 hours were
0 for each of the three animals tested. Under the experimental
conditions of this test, the test substance is not irritating to skin.
An in vivo eye irritation study in male New Zealand White rabbits was
conducted to evaluate the eye irritation potential of the test substance
according to OECD guideline 405 and under GLP conditions (Prakash,
2011). One hundred mg (0.1 g) of the test substance was instilled into
the conjunctival sac of the left eye of the animal after gently pulling
the lower lid away from the eyeball. The lids were gently held together
for about one second, in order to minimize loss of the test substance.
The right eye of each rabbit remained untreated and served as the
reference control. The ocular lesions were evaluated at 1, 24, 48 and 72
hours according to the scale for scoring ocular lesions. Under the
conditions of this study, the test substance caused slight conjunctival
irritation and slight corneal opacity in the rabbit eye, which cleared
by 72 hours in all animals. The mean conjunctivae, chemosis and iris
scores after 24, 48, and 72 h were 1.3/0.3/0.3, 0.7/0/0 and 0.7/0/0 for
the 3 individual animals, respectively. The mean scores for chemosis
after 24, 48, and 72 h were 0 for all 3 individual animals. Therefore,
the test substance is considered as not irritating to the skin. Under
the experimental conditions of this in-vivo animal test, the test
substance is considered not irritating to the eyes.
In addition, a GLP-compliant Hen's Egg Test on Chorioallantoic Membrane
(HET-CAM) was performed according to the ICCVAM recommended HET-CAM
Method Protocol (ICCVAM, 2006, updated draft: 11 May 2009) to assess the
irritating potential of the test substance by measuring toxic effects on
the blood vessels under the CAM of fertilised chicken eggs (Andres,
2012). In this in vitro assay, the vasculated CAM of the eggs was
prepared and exposed to the undiluted test substance, the vehicle
(physiological saline) or the positive control substances (1% sodium
dodecyl sulphate and 1 N sodium hydroxide solution). During an
observation period of 5 min, the blood vessels of each individual egg
were monitored for the onset of haemorrhage, lysis and coagulation and
the times required to induce these effects were measured. Based on the
measured times, the irritation score (IS) was calculated. The positive
and negative controls yielded the expected results. The undiluted test
substance induced coagulation and lysis of the blood vessels in all eggs
after 163 and 46 s, respectively. The calculated mean IS value for the
test substance was 10.08, which corresponds to a classification as
severely irritant (IS > 9). Under the experimental conditions of this
HET-CAM test in-vitro, the test substance may be considered as corrosive
to the eyes.
However, based on the outcome of the in vivo eye irritation study in
rabbits, the substance is not considered as irritating to the eyes, and
thus the result of the HET-CAM assay is not taken into account for
classification and labelling purposes.
This information is not available.
Schrage A, Gamer AO, van Ravenzwaay B, Landsiedel R. (2010).
Experience with the HET-CAM method in the routine testing of a broad
variety of chemicals and formulations. Altern Lab Anim. 38(1): 39-52
The available data on skin and eye irritation of the substance do
not meet the criteria for classification according to Regulation (EC)
1272/2008 or Directive 67/548/EEC, 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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