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EC number: 214-244-2
CAS number: 1117-31-3
Justification for grouping of substances and read-across
There are no data available on the genetic toxicity of
1,3-Butylene diacetate (CAS 1117-31-3). In order to fulfil the standard
information requirements set out in Annex VIII, 8.4, in accordance with
Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a
structurally related substance is conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006,
"information on intrinsic properties of substances may be generated by
means other than tests, provided that the conditions set out in Annex XI
are met.” In particular for human toxicity, information shall be
generated whenever possible by means other than vertebrate animal tests,
which includes the use of information from structurally related
substances (grouping or read-across).
Having regard to the general rules for grouping of substances and
read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC)
No 1907/2006, whereby physicochemical, toxicological and
ecotoxicological properties may be predicted from data for reference
substance(s) by interpolation to other substances on the basis of
structural similarity, Ethylene diacetate (CAS 111-55-7) and
Propane-1,2-diyl diacetate (CAS 623-84-7) are selected as reference
substances for assessment of genetic toxicity in vitro.
The read-across is based on the structural similarity between the
source and target substances which are all esters of similar
di-functional alcohols with the carboxylic acid acetic acid. A detailed
analogue approach justification is provided in the technical dossier
(see IUCLID Section 13).
Overview of Genetic toxicity
Genetic toxicity (mutagenicity) in bacteria in-vitro
RA: CAS 111-55-7
Experimental result: Negative
Genetic toxicity (cytogenicity) in mammalian cells in-vitro
Genetic toxicity (mutagenicity) in mammalian cells in-vitro
RA: CAS 623-84-7
(a) The substance subject to the REACh
Phase-in registration deadline of 31 May 2013 is indicated in bold font.
Only for this substance a full set of experimental results and/or
read-across is given.
(b) Reference (read-across) substances are
indicated in normal font. Lack of data for a given endpoint is indicated
Gene mutation in bacteria
One study investigating the induction of gene mutation in bacteria
by Ethylene diacetate is available (Lawlor, 2000). The study was
conducted according to OECD guideline 471 under GLP conditions. The
tester strains, Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA
100 and the E. coli strain WP2 uvr A pKM 101 were used.
The experiments were performed according to the plate
incorporation procedure at concentrations from 10-5000 µg/plate in the
first experiment and from 33.3-5000 µg/plate in the second experiment
with and without a metabolic activation system (S9-mix from rats treated
with Aroclor 1245). The included positive and negative controls in the
experiments showed the expected results and were therefore considered as
valid. No increase in the number of revertant colonies was observed in
any of the bacterial strains, with and without metabolic activation
system. No cytotoxicity was observed in the main study up to the limit
concentration of 5000 µg/plate. Under the conditions of this study,
Ethylene diacetate did not induce mutations in the bacterial mutation
tests in the absence and presence of a metabolic activation system in
any of the strains tested.
In vitro cytogenicity in mammalian cells
A study investigating the cytogenicity in mammalian cells in-vitro
with Ethylene diacetate was performed in accordance with OECD guideline
473 under GLP conditions (Murli, 2000). The induction of structural
chromosome aberrations was evaluated in vitro in Chinese hamster ovary
(CHO) cells, incubated for 3 h with and without and for 18 h without a
metabolic activation system (S9-mix from rats treated with Aroclor
1245). Concentrations of 515-1500 µg/mL (3 h incubation, Experiment I)
and 500-1500 µg/mL (18 h and 3 h incubation, Experiment II) of the test
substance in the vehicle water were applied. The negative as well as the
positive controls showed the expected results and were within the range
of historical control data. The frequency of polyploidy cells with and
without metabolic activation was within the expected range. In the
experiments without metabolic activation and 18 h incubation, an
influence of the test substance was observed which led to a reduction in
the mitotic index. No statistically or biologically significant increase
in the incidence of chromosome aberrations was observed. Therefore,
under the conditions of the study, the test substance did not show
clastogenic activity in the chromosomal aberration test with and without
metabolic activation performed in CHO cells in vitro.
In vitro gene mutation in mammalian cells
The in vitro mammalian cell gene mutation study of
Propane-1,2-diyl diacetate was carried out according to OECD guideline
476 under GLP conditions (Indrani, 2011). Gene mutations in the HPRT
locus were investigated in Chinese hamster ovary (CHO) cells in the
presence and absence of a metabolic activation system (S9-mix from rats
treated with Aroclor 1245).
In the first experiment, cells were exposed for 4 h to test
substance at concentrations of 13-1602 µg/mL (in sterile water) with and
without metabolic activation. Concentrations of the second experiment
without metabolic activation for an exposure time of 4 h ranged from
20-1602 µg/mL with and without metabolic activation. The vehicle and
positive controls in the study showed the expected results and were
within the range of historical control data. No cytotoxicity was
observed up to the highest tested concentration of 1602 µg/mL. There was
no significant increase in the number of forward mutations at the HPRT
locus of CHO cells treated with the test material, neither in the
presence nor in the absence of a metabolic activation system. Under the
conditions of the study, Propane-1,2-diyl diacetate did not show gene
mutation activity in this test performed in CHO cells in vitro.
Conclusion for genetic toxicity
The studies with Ethylene diacetate (CAS 111-55-7) investigating
genetic mutations in bacteria in-vitro and cytogenicity in mammalian
cells in-vitro provided negative results. In addition, no mutagenicity
in mammalian cells in-vitro was observed with the structurally related
analogue substance Propane-1,2-diyl diacetate (CAS 623-84-7).
Therefore, based on read-across the available data do not provide
any indications for a potential genetic toxicity of 1,3-Butylene
diacetate (CAS 1117-31-3).
Justification for selection of genetic toxicity endpoint
Hazard assessment is conducted by means of read-across from structural analogues. No study was selected, since all available in vitro genetic toxicity studies were negative. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Short description of key information:
Based on read-across from Ethylene diacetate (CAS 111-55-7) and Propane-1,2-diyl diacetate (CAS 623-84-7):
In vitro gene mutation in bacteria: negative with and without metabolic activation
In vitro cytogenicity in mammalian cells: negative with and without metabolic activation
In vitro gene mutation in mammalian cells: negative with and without metabolic activation
Endpoint Conclusion: No adverse effect observed (negative)
Based on read-across from the source substances Ethylene diacetate
(CAS 111-55-7) and Propane-1,2-diyl diacetate (CAS 623-84-7) following
an analogue approach, all available data on genetic toxicity do not meet
the criteria for classification according to Regulation (EC) 1272/2008
or Directive 67/548/EEC, and the data are therefore conclusive but not
sufficient for 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.
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