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EC number: 201-304-8
CAS number: 80-73-9
There were no deaths and no signs of ill health or toxicity
observed during this study. Greasy fur on the head was noted following
each dosing occasion, this was related to unoccluded dermal
administration of a liquid formulation/vehicle and not an effect of the
No signs of dermal irritation were seen on the ear during the
There was no indication of an effect of treatment on bodyweight
gain. A loss in bodyweight was noted for all mice in the 50% treatment
group and one mouse from in the positive control group over the study
Results of preliminary investigation
Mortality and clinical signs
Substance as supplied:
Greasy fur on the head was noted following dosing on days 1 and 2. At
the pre-dose check on Day 3 signs of toxicity were noted in the both
females, these included underactivity, hunched posture, fast breathing,
partially closed eyelids, tilted trunk and irregular breathing. Approximately
80 minutes later one female died and as this
level was clearly unsuitable for administration on the main study the
remaining animal was sacrificed.
Greasy fur on the head was noted following each dosing occasion,
this was related to unoccluded dermal administration of a liquid
formulation/vehicle and not an effect of the test substance. No deaths
or signs of toxicity were seen throughout the study.
Slight erythema was observed on the ears of one mouse on Day 3.
No erythema was observed on the ears of either mouse on Days 1 to
A loss in bodyweight was noted for both mice dosed at 50% v/v over
the study period On the basis of the results from the preliminary
investigation, 50% v/v was considered a suitable high concentration for
administration in the main phase of the study.
Group dpm/node and Stimulation Index
Number of lymph nodes per animal
+ = positive
- = negative
HCA 25% v/v
† Stimulation Index of 3 or more indicates a positive result
dpm Disintegrations per minute less background count of 37.10
AOO Acetone:olive oil (4:1 v/v) (vehicle control)
HCA Hexyl cinnamic aldehyde (positive control)
In a study to assess the skin sensitization potential using the
local lymph node assay (LLNA), mice were exposed to DMI
at concentrations of 10, 25 or 50% v/v. The
proliferative response of the lymph node cells (LNC) from the draining
auricular lymph nodes was assessed five days following the initial
application. The SI obtained for 10, 25 and 50% v/v were
0.7, 1.1 and 0.4 respectively which indicates that DMI did not show the
potential to induce skin sensitization. The EC3 value was
determined to be higher than 50% v/v.
The SI for the positive control substance hexyl cinnamic aldehyde
was 6.4, which demonstrates the validity of this study.
Migrated from Short description of key information:
DMI is not regarded as a potential skin sensitizer.
Justification for selection of skin sensitisation endpoint:
One study is available and valid
Skin sensitisation - the stimulation index determined in a local lymph
node assay was less than three for all tested concentrations. The
substance is therefore regarded as not sensitising to skin.
Respiratory sensitisation - no data available.
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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