Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 618-561-0
CAS number: 9046-10-0
In a key reverse mutation test in bacteria (Ames test) according to OECD
guideline 471, the test substance proved to be negative for mutagenicity
with and without metabolic activation (Wisher, 2020). This was confirmed
in one supporting, reliable Ames test.
In a reliable, key mouse lymphoma test performed according to OECD
guideline 476 (Litton Bionetics Inc, 1982; Klimisch 2), the test
substance tested negative with and without metabolic activation.
in the Balb3T3 in vitro transformation assay, the test substance was
considered to be inactive (Litton Bionetics Inc, 1982; Klimisch 2)
Summary of Data from Transformation Assay
Total number of foci
Number of Foci/Dish Absolute/Log10
(MCA) 2.5 microgram/ml
A reliable, key in vivo micronucleus test on mouse bone marrow
erythrocytes was performed according to OECD guideline 474 (Bioreliance,
2010). The test substance demonstrated to be negative up to dose levels
of 500 mg/kg.
Summary of Bone Marrow Micronucleus Analysis Following a Single Oral
Administration of Jeffamine D-230 in ICR Mice
Treatment (20 mL/kg)
Numbe of animals
(Mean +/- SD
Number of MPCE/1000 PCE (Mean +/- SD)
Number of MPCE/1000 PCE (scored)
0 / 10000
125 mg/kg bw
250 mg/kg bw
500 mg/kg bw
*133 / 10000
*139 / 10000
1 / 10000
3 / 10000
Statistically significant increase compared to vehicle control, p < 0.05
- Bacterial reverse mutation assay: In a
key bacterial reverse gene mutation assay (Wisher, 2020; Klimisch 1;
according to OECD 471) with multiple strains of Salmonella
typhimurium (TA98, TA100, TA1535, TA1537) and Escherichia Coli (WP2
uvrA), the test item was negative both with and without metabolic
supporting bacterial reverse gene mutation assay (Pharmakon Research
International Inc., 1982; Klimisch 2; similar to OECD 471) with multiple
strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537
and TA1538), the test substance was negative both with and without
mutation in mammalian cells: In a mammalian cell gene mutation assay
with L5178Y mouse lymphoma cells, exposure to the test substance (Litton
Bionetics, Inc., 1982; Klimisch 2; similar to OECD 476) in the presence
and absence of metabolic activation did not induce mutations at the
thymidine kinase locus up to a dose level of 6000 nl/ml.
- In vitro transformation assay in mammalian cells : In an in
vitro BALB/3T3 cell transformation assay (Litton Bionetics, Inc.,
1982, Klimisch 2), the test substance did not induce a significant
increase in the number of transformed foci over the concentration range
of 450 nl/ml to 75 nl/ml. Therefore, the test substance is considered to
be inactive in the BALB/3T3 in vitro transformation assay.
- an in vitro cytogenicity study in mammalian cells or an in vitro
micronucleus tests does not need to be performed as an adequate in vivo
study is available
- micronucleus test: In an in vivo micronucleus test on mouse
bone marrow erythrocytes, performed according to OECD 474, the animals
were exposed orally (via gavage) with 125, 250 and 500 mg/kg. This did
not induce a statistically significant increase in micronuclei in the
hemopoietic cells of the mouse bone marrow at the time intervals
evaluated under the experimental condition of this assay. No toxicity
was observed. Vehicle and positive controls were valid.
Based on the results and according to the criteria laid down in the CLP
regulation (EC)1272/2008, the test substance is considered to be non
genotoxic in vitro and in vivo. Therefore, the substance
does not warrant classification.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again