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EC number: 214-244-2
CAS number: 1117-31-3
Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):
Skin: not irritating
Eye: not irritating
Justification for grouping of substances and read-across
There are no sufficient data available on the eye irritating
potential of 1,3-Butylene diacetate (CAS 1117-31-3). In order to fulfil
the standard information requirements set out in Annex VIII, 8.2, 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 eye irritation.
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
CAS 623 -84 -7
A non-GLP skin irritation study is available for the structurally
related substance Propane-1,2-diyl diacetate, in which 0.01 mL of the
undiluted test substance was applied to the shaved bellies of 5 rabbits
for a period of 24 h under open conditions (Union Carbide Corporation,
1965). No skin irritation was observed up to 24 h after exposure.
However, only a tenth of the dose used according to OECD guideline 404
was applied and no scoring of skin reaction was performed. Therefore,
the study did not meet important criteria of today standard methods and
was thus not taken into account for hazard assessment.
However, the available study on acute dermal toxicity from the
read-across source substance Propane-1,2-diyl diacetate (CAS 623-84-7)
does not indicate skin irritation or corrosion up to the limit dose
level (see Acute toxicity). Therefore, based on read-across, an in vivo
skin irritation study does not need to be conducted according to Column
2 of Annex VIII, Section 8.1.1, of Regulation (EC) No 1907/2006, and the
substance is thus considered to be not irritating.
The eye irritation properties of Propane-1,2-diyl diacetate were
tested in a study according to OECD guideline 405 under GLP conditions
(Dow, 1994). In a group of 3 female rabbits (New Zealand White), 0.1 mL
of the undiluted test substance was applied into one eye. The eyes were
observed and reactions were evaluated 1, 24, 48 and 72 h after
No effects on cornea, iris and no conjunctival redness were
observed in any animal during the study period. No further local or
systemic effects were reported.
Under the experimental conditions described, it was concluded,
that no evidence of eye irritation properties were seen after treatment
with Propane-1,2-diyl diacetate.
Conclusion for skin and eye irritation
In conclusion, 1,3-Butylene diacetate (CAS 1117-31-3) is
considered to be not irritating to the skin based on read-across data
for acute dermal toxicity (see Acute toxicity). One study from the
structurally related source substance Propane-1,2-diyl diacetate (CAS
623-84-7) did not show eye irritation properties.
Based on this result, no skin or eye irritation potential for
1,3-Butylene diacetate (CAS 1117-31-3) was identified.
Justification for selection of skin irritation / corrosion endpoint:
No study selected, since hazard assessment is conducted by means of read-across from an acute dermal toxicity study with 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).
Justification for selection of eye irritation 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 and eye irritation 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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