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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).
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