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EC number: 947-946-9
CAS number: -
Preliminary Screening Test Results:
One mouse treated with the test item
at 100% (undiluted) and one mouse treated with 50% v/v acetone/olive oil
were killed due to the severity of clinical signs, including body weight
losses of 15.3% and 17.0%, respectively on Day 5.
No signs of systemic toxicity, visual local
skin irritation or irritation indicated by an equal to or greater than
25% increase in mean ear thickness were noted in the animal treated with
the test item at a concentration of 25% v/v in acetone/olive oil or the
initial animal treated with the test item at a concentration of 50% v/v
in acetone/olive oil but the initial animal treated at a concentration
of 50% v/v showed a body weight loss of approximately 9.9%
The results indicated that the test item at
concentrations of ≥ 50% v/v in acetone/olive oil 4:1 caused systemic
toxicity (> 5% reduction in body weight) in mice. Based on this
information the dose levels selected for the main test were 25%, 10% and
5% v/v in acetone/olive oil 4:1.
Main Test Results:
The Stimulation Index expressed as the mean
radioactive incorporation for each treatment group divided by the mean
radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) in acetone/olive oil 4:1
The EC3 was calculated to be
Body weight change of the test animals
between Day 1 and Day 6 was comparable to that observed in the
corresponding control group animals over the same period.
study was performed to assess the skin sensitization potential of the
test item in the CBA/Ca strain mouse following topical application to
the dorsal surface of the ear.
preliminary screening tests in mice at concentrations of 100%, 50% and
25% v/v in acetone/olive oil 4:1, in which the test item caused systemic
toxicity at concentrations of ≥ 50% and no clinical signs of toxicity at
a concentration of 25%, this concentration was selected as the highest
dose investigated in the main test of the Local Lymph Node Assay. Three
groups, each of five female animals, were treated with 50 μL (25 μL per
ear) of the test item as a solution in acetone/olive oil 4:1 at
concentrations of 25%, 10% or 5% v/v. A further group of five female
animals was treated with acetone/olive oil 4:1 alone. The sensitivity of
the test system was confirmed periodically using the positive control
Stimulation Index expressed as the mean radioactive incorporation for
the treatment group divided by the mean radioactive incorporation of the
vehicle control group, was 6.37 at a concentration of 25%v/v test item
in acetone/olive oil, the EC3was calculated to be 8.5%.
the conditions of the test, the test item was considered to be a
moderate skin sensitizer with an EC3of 8.5%.
The test item is classified as a contact sensitizer (Category 1B)
according to Regulation (EC) No. 1272/2008, relating to the
Classification, Labelling and Packaging of Substances and Mixtures and
the United Nations Globally Harmonized System of Classification and
Labelling of Chemicals.
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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