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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 skin sensitising potential of
1,3-Butylene diacetate (CAS 1117-31-3). In order to fulfil the standard
information requirements set out in Annex VII, 8.3, 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 skin sensitisation.
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 irritation / corrosion
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
One study, investigating the skin sensitising properties of
Propane-1,2-diyl diacetate is available. The study was conducted
according to OECD 406 in compliance with GLP (Weterings, 1986). Female
guinea pigs (20 in test group, 10 in control group) were induced with
nine occlusive epicutaneous exposures at 25% of the test substance in
propylene glycol. The epicutaneous challenge was conducted ten days
after the last induction using 0.05 mL of a series of test substance
concentrations (25, 5, 1 and 0% (v/v)) in propylene glycol. The negative
control group was treated with the vehicle propylene glycol only. No
positive control data was included in the study for reliability check.
On Day 29, a diffuse skin reddening at the skin site exposed to
25% (v/v) Propane-1,2-diyl diacetate was observed in two animals
(10.5%). The complete disappearance of the observed skin reddening 24 h
later might indicate that the effects were not due to sensitisation. No
further skin reactions were observed.
In summary, only two animal of the treatment group (10.5%) showed
a positive result for skin sensitisation and thus Propane-1,2-diyl
diacetate (CAS 623-84-7) was considered to be not sensitising.
Conclusion for skin sensitisation
The structurally related source substance Propane-1,2-diyl
diacetate (CAS 623-84-7) showed no skin sensitisation potential in
Based on this result, no skin sensitisation potential for
1,3-Butylene diacetate (CAS 1117-31-3) was identified.
Migrated from Short description of key information:
Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):
Skin sensitisation: not sensitising
Justification for selection of skin sensitisation endpoint:
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 substance Propane-1,2-diyl
diacetate (CAS 623-84-7) following an analogue approach, the available
data on skin sensitisation properties of 1,3-Butylene diacetate (CAS
1117-31-1) 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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