Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-304-8
CAS number: 80-73-9
Skin irritation, rabbits: slightly irritating
Eye irritation, rabbits slightly irritating with irreversible effects observed
4 -hour exposure period - very slight erythema was noted at all treated
skin sites at the 24 and 48 -hour observations. All treated skin sites
appeared normal at the 72-hour observation.
1 -hour exposure period - very slight erythema was noted at the treated
skin site at the 24 -hour observation. The treated skin site appeared
normal at the 48 -hour observation.
3 - minute exposure period - no evidence of skin irritation was noted
during the study.
A dermal irritation test was performed to assess the irritation to skin
caused by DMI. The study was conducted according to official test
guidelines, and in compliance with GLP. 0.5 ml of test substance was
applied to the skin of three albino rabbits and held in place with a
semi occlusive dressing for four hours. At the end of the exposure
period, the test substance was washed off with water. The treatment site
was observed approximately one hour, 24, 48 and 72 hours after
application. There was no evidence of skin irritation for three minutes
expsoure. Very slight erythema was noted with one hour exposure
(24 hour observation period). A very slight erythema was noted with all
treated skin sites after 4 hours exposure at the 24 and 48 observation
periods, but appeared normal at the 72 hour observation period.
Eye irritation An eye irritation test was performed to determine the
potential of DMI to cause irritation in the eye. The study was conducted
in accordance with official test guidelines, and in compliance with GLP.
One rabbit was administered a single ocular dose of a volume of 0.1 mL
of the test substance and observed for nine days after instillation. A
crimson-red or beefy-red conjunctival appearance was evident throughout
the first 72-hours after instillation. Very-slight or slight chemosis
and slight or moderate discharge were apparent during this time. From
24-hours after instillation scattered or diffuse areas of opacity
covering up to three quarters of the corneal surface were evident.
Iritis was apparent 72-hours after instillation. One week after
instillation (Days 8 and 9) injection of the conjunctival blood vessels,
scattered or diffuse area of opacity covering up to a quarter of the
corneal surface and an area of pannus were evident. Pannus is regarded
as an irreversible effect, consequently the study was terminated after
the Day 9 assessment and no further animal was committed to the study.
Justification for selection of skin irritation / corrosion endpoint:
This study is conducted in accordance with a recognised, well established test method. Of the other available studies available for this endpoint, one is unassignable (Klimisch code 4) and the other, although well conducted under GLP, is carried out as an assessment of the test site in a dermal developmental/teratology study. It therefore does not follow strictly the test conditions as prescribed in the test methods used for classification of substance for dermal irritancy, however the data do serve to support the finding that DMI is not irritating to the skin.
Justification for selection of eye irritation endpoint:
An in vitro study did not show conclusively that the substance is an eye irritant and therefore an in vivo study was undertaken. The in vivo study takes precedence over the in vitro study in the classification of DMI for eye irritancy effects.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: slightly irritating
Although DMI is slightly irritating, effects are reversible and not
sufficient for the substance to be classified as corrosive or irritant.
DMI is slightly irritating to the eye, but some effects (pannus) are not
reversible. DMI therefore is classified as Category 1 (Irreversible
effects on the eye).
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again