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EC number: 603-837-5
CAS number: 134605-64-4
The study was performed to assess the irritancy potential
of the test material to the eye following a single application in the
New Zealand White rabbit. The study was performed to GLP and the method
was designed to meet the requirements of EPA Guideline 81 -4. A total of
9 animals were used and split into two groups with group 1 containing 6
animals and group 2 containing 3 animals. A volume of 0.1 ml (61mg) of
the test material was placed into the conjunctival sac of the right eye
of all 9 animals. The left eye remained untreated and was used for
control purposes. The eyes of the rabbits in Group 1 remained unflushed
immediately after treatment while the treated eyes of the rabbits in
Group 2 were flushed with lukewarm tap water for 1 minute starting 30
seconds after test material instillation. Assessment of ocular
damage/irritation was made approximately 1 hour and 24, 48 and 72 hours
following treatment. Additional observations were made at 96 hours after
treatment for the animals in Group 1. Irritation was graded and scored
according to the Draize technique using a penlight as the source of
illumination. A sodium fluorescein examination was used to aid in
revealing possible corneal injury at 24 hours.
In the group 1 test animals, no corneal effects (opacity)
were noted during the study. Iridial inflammation (grade 1) was noted
for four animals at one hour. Minimal to moderate (grade 1 to 2)
conjunctival irritation was noted for all animals one hour after
treatment and at the 24 to 72 -hour observations. All treated eyes
appeared normal at the 96h observation. In the group 2 test animals, no
corneal effects (opacity) were noted during the study. Iridial
inflammation (grade 1) was noted in 1 animal at one hour. Minimal to
moderate (grade 1 to 2) conjunctival irritation was noted for all
animals one hour after treatment and at the 24 -hour observations. All
treated eyes appeared normal at the 48h observation. The test material
produced a maximum group mean score of 9.7. Based on these results and
according to the classification scheme of Kay and Calandra (1962), the
test material is mildly irritating to eyes unwashed immediately after
treatment and minimally irritating to eyes receiving a washout after
treatment. The test material is considered to be non irritating
according to the Commission Directive 93/21/EEC.
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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