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EC number: 500-078-0
CAS number: 31923-84-9
1 - 4.5 moles propoxylated
Skin sensitisation in vivo (LLNA, OECD 429): not sensitising
The "positive level" of ear swelling which is 2 x 10E-2 mm increase,
i.e. about 10% of the control values, has not been reached or exceeded
in any dose group. No substance specific effects were determined for ear
weights either. It has to be clarified that the "positive levels"
mentioned above are exclusively defined for the NMRI outbred mice used
for this study. Such positive limits have to be calculated for each
strain of mice individually. The body weights of the animals were not
affected by any treatment.
Additional detailed tables are attached below under 'Attached background
In order to investigate the skin sensitisation potential of
ethane-1,2-diol, propoxylated (CAS No.31923-84-9, EC No. 500-078-0), the
modified Local Lymph Node Assay was performed according to OECD
guideline 429 and under GLP conditions (rel 1-key, LLNA, OECD 429, Bayer
Schering Pharma, 2009f, T6079406). 24 female NMRI mice (6 animals/test
item group and 6 control animals) were used to determine if there is any
specific (sensitising) or non-specific stimulating potential of the test
substance. The following test substance concentrations were used: 0
(vehicle control), 2%, 10% and 50% formulated in dimethylformamide (DMF)
to yield a solution. Compared to vehicle-treated animals, none of the
parameters measured in the substance treated groups, i.e. cell counts
and weights of the draining lymph nodes, ear weights and ear swelling,
reached or exceeded the "positive levels" defined for this assay. In
conclusion, the results show that ethane-1,2-diol, propoxylated has no
sensitising potential in mice after dermal application of solutions with
up to and including a concentration of 50%.
The available data on skin sensitisation with ethane-1,2-diol,
propoxylated (CAS No.31923-84-9, EC No. 500-078-0) do not meet the
criteria for classification according to Regulation (EC) No. 1272/2008
(CLP) and are therefore conclusive but not sufficient for classification.
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