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EC number: 214-244-2
CAS number: 1117-31-3
In order to fulfil the standard information requirements set out
in Annex IX, Section 8.7.1, of Regulation (EC) No 1907/2006,
substance-tailored exposure-driven testing is conducted in accordance
with Annex XI, Section 3.
Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):
(Pre-natal) development: NOAEL (rabbit) = 1058 mg/kg bw/day
Justification for grouping of substances and read-across
There are no data available on the (pre-natal) developmental
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, Propane-1,2-diyl diacetate (CAS 623-84-7) is
selected as reference substance for assessment of (pre-natal)
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 developmental toxicity
RA CAS 623-84-7
NOAEL: 1058 mg/kg bw/day (m,f)
(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
Toxicity to reproduction – (pre-natal)
A prenatal developmental toxicity study with Propane-1,2-diyl
diacetate was conducted according to OECD 414 in compliance with GLP
(Smiths van Prooije, 1989). Groups of 28 female New Zealand White
rabbits per treatment group were dermally treated with undiluted
Propane-1,2-diyl diacetate at doses of 0.3 and 1.0 mL/kg bw/day
(high-dose corresponding to 1058 mg/kg bw/day) from Day 6-18 post
mating. A concurrent negative control groups treated with distilled
water only were included in the testing.
In the study, no maternal mortality occurred and no
substance-related clinical signs of toxicity were observed. Mean
maternal body weights and food intake were comparable in all groups.
Mean weight gain during treatment was lower in the low-dose group when
compared with controls. During the study, no dermal reactions were
observed at the application sites of the treated rabbits that could be
related to the dermal application of Propane-1,2-diyl diacetate.
Furthermore, at scheduled necropsy no macroscopic changes related to
treatment were noted in maternal animals. Mean absolute weights of the
ovaries, gravid and empty uterus did not show significant differences
between test groups and control. No compound-related differences were
observed in gestation index, pre-and post-implantation loss, embryonic
deaths, mean numbers of resorptions and total fetuses of the test groups
in comparison to the control group.
Mean foetal and placental weight were slightly lower in the
high-dose group, however without statistical significance. No
macroscopically visible malformations were observed in foetuses that
could be related to treatment. No statistically significant differences
were observed in the incidence of skeletal malformations between the
high-dose group and the controls, either for each observation separately
or for the total incidence of skeletal malformations.
Therefore, due to the lack of adverse effects in this study, the
NOAEL for maternal toxicity and developmental toxicity for rabbits was
considered to be 1058 mg/kg bw/day (m,f).
Conclusion for developmental toxicity
A study investigating the developmental toxicity is available from
the structurally related analogue substance Propane-1,2-diyl diacetate
(CAS 623-84-7). The study from Propane-1,2-diyl diacetate did not show
treatment-related effects up to the highest tested dose level. Thus, no
hazard for developmental toxicity was identified and a NOAEL for
developmental toxicity is considered to be the highest dose level (1058
mg/kg bw/day (m, f)).
Justification for selection of Effect on developmental toxicity: via dermal route:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study 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).
Based on read-across from the source substances Propane-1,2-diyl
diacetate (CAS 623-84-7) following an analogue approach, the available
data on (pre-natal) developmental 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
Data are lacking in regard to toxicity to reproduction (fertility)
and effects via lactation.
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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