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EC number: 500-147-5
CAS number: 61788-85-0
1 - 6.5 moles ethoxylated
In an Ames test the substance was tested in Salmonella typhimurium
strains TA1535, TA1537, TA98, TA100 and E. coli strain
WP2uvrA in presence and absence of metabolic activation.
No increase in mutant frequency was reported in any of the strains
tested both in presence and absence of metabolic activation. The
substance is considered to be non-mutagenic under the conditions of this
The substance was tested in the L5178Y TK +/- Mouse Lymphoma Assay
according to OECD 490 up to precipitation level. Exposure was either 4
hours (with and without metabolic activation) or 24 hours (without
metabolic activation). No increase in the mutant frequency at the TK +/-
locus was reported (evaluation with the Global Evaluation Factor (GEF)
of 126 E-06). Therefore it is concluded that the substance is
non-mutagenic in this assay.
Duplicate cultures of human lymphocytes, treated with the
substance, were evaluated for chromosome aberrations at up to four dose
levels (maximum dose 160 mg/mL, lowest precipitating level), together
with vehicle and positive controls in presence of metabolic activation
(4 hours) and in absence of metabolic activation (4 and 24 hours). The
substance did not demonstrate any marked toxicity and did not induce any
statistically significant increases in the frequency of cells with
aberrations and was considered to be non-clastogenic to human
lymphocytes in vitro.
details see attached document
Duplicate cultures of human lymphocytes, treated with the test
item, were evaluated for chromosome aberrations at up to four dose
levels, together with vehicle and positive controls. In this study,
three exposure conditions were investigated;4 hours exposure in
the presence of an induced rat liver homogenate metabolizing system
(S9), at a 2% final concentration with cell harvest after a 20-hour
expression period, 4 hours exposure in the absence of metabolic
activation (S9) with a 20-hour expression period and a 24-hour exposure
in the absence of metabolic activation.
The dose levels used in the Main Experiment were selected using
data from the preliminary toxicity test where the results indicated that
the maximum concentration should be limited by precipitate. The dose
levels selected for the Main Test were as follows:
Final concentration of substance evaluated
4(20)-hour without S9
0, 5,10, 20, 40, 80, 160
4(20)-hour with S9 (2%)
24-hour without S9
All vehicle (Acetone) controls had frequencies of cells with
aberrations within the range expected for normal human lymphocytes.
All the positive control items induced statistically significant
increases in the frequency of cells with aberrations. Thus, the
sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item did not demonstrate any marked toxicity and did not
induce any statistically significant increases in the frequency of cells
with aberrations, using a dose range that included a dose level that was
the lowest precipitating dose level.
The test item,was considered to be non-clastogenic to human
lymphocytes in vitro.
4-hours -S-9 Treatment
4-hours +S-9 Treatment
MF threshold for a positive response = 269.34
MF threshold for a positive response = 211.13
MF threshold for a positive response = 330.05
Positive wells per tray, 96 wells plated
small colony mutants
Based on the available information no classification for mutagenicity is
necessary according to Regulation (EC) No 1272/2008 (CLP).
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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