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EC number: 230-896-0
CAS number: 7360-38-5
skin irritation/corrosion, rabbit (OECD 404): not irritating
Read-across from structural analogue source substances glycerides,
mixed decanoyl and octanoyl (CAS 73398-61-5).
eye irritation, rabbit (OECD 405): not irritating
Read-across from structural analogue source substance
propane-1,2,3-triyl triheptanoate (CAS 620-67-7).
The skin irritation / corrosion potential of the target substance
is estimated based on an adequate and reliable in vivo study with the
structural analogue source substance triglycerides, mixed
decanoyl and octanoyl (CAS 73398-61-5). No edema formation was
noted in any animal during the study period. The test item did not cause
any skin reaction throughout the whole study period. As explained in the
analogue justification, the differences in molecular structure between
the target and the source substances are unlikely to lead to differences
in the skin irritation / corrosion potential. Therefore, the target
substance is also considered to exhibit no skin irritating properties.
The eye irritation potential of the target substance is estimated
based on adequate and reliable in vivo studies of structural analogue
source substances propane-1,2,3-triyl trisheptanoate (CAS
620-67-7) and triglycerides, mixed decanoyl and octanoyl
(CAS 73398-61-5). Application of the unchanged source substance triglycerides,
mixed decanoyl and octanoyl (CAS 73398-61-5) resulted in only
slight to moderate effects on the iris and the conjunctivae (redness and
chemosis). Iridal effects were fully reversible within 24 h,
conjunctivae redness and chemosis were fully reversible within 48 h.
Administration of the source substance propane-1,2,3-triyl
trisheptanoate (CAS 620-67-7) resulted in marked hyperemia of some
blood vessels in all animals. After 24-72 h, no further symptoms of
irritation to the eye mucosae, cornea and iris were observed in any
animal. Only the skin of the outer eyelids showed slight erythema after
24 h in all animals, which subsided after 48 h. All effects detected
were fully reversible within the observation period of the respective
studies. As explained in the analogue justification, the differences in
molecular structure between the target and the source substances are
unlikely to lead to differences in the eye irritation potential. Therefore,
no significant eye irritation potential is identified for the target
The potential of skin irritation of propane-1,2,3-triyl-
2-ethylhexanoate was tested in a study performed equivalently to OECD
guideline 404 (EVIC-CEBA, 1989b), but only limited data are given. 0.5
mL of substance was applied to intact and abraded skin of three New
Zealand rabbits under occlusive conditions for 24 h. While light
erythema was noted in 2 animals, which was fully reversible within 72 h
after application, no edema could be detected in any animal. Based on
these observations, no irritation potential by propane-1,2,3-triyl-
2-ethylhexanoate was identified.
In order to fulfil the standard information requirements set out in
Annex VIII, 8.1, in accordance with Annex XI, 1.5, of Regulation (EC)
No. 1907/2006 read-across from the structurally related analogue
substance glycerides, mixed decanoyl and octanoyl (CAS 73398-61-5) is
conducted. Glycerides, mixed decanoyl and octanoyl was investigated in a
study according to OECD guideline 404 (Safepharm, 1988a). The undiluted
test substance (0.5 mL) was applied to the shaved skin of six New
Zealand White rabbits under semiocclusive conditions for 4 h. The
untreated site of the animals served as control. The scoring of skin
reactions (erythema and edema) was performed 24, 48 and 72 h after
removal of the dressing. The test item did not elicit any skin reactions
at the application site of any animal at any of the observation time
points. No signs of systemic toxicity were seen. The mean erythema and
edema scores after 24, 48 and 72 h were 0 for all six animals. Thus, no
irritation to skin was found.
There are no data available on the eye irritation potential of
propane-1,2,3-triyl 2-ethylhexanoate. 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 the
structurally related analogue substances propane-1,2,3-triyl
trisheptanoate (CAS 620-67-7) and glycerides, mixed decanoyl and
octanoyl (CAS 73398 -61 -5) is conducted.
In a study conducted according to GLP and OECD guideline 405, the
structural analogue propane-1,2,3-triyl trisheptanoate was tested in
three male Small White Russian rabbits which received an instillation of
0.1 mL into the right eye, while the left eye served as control (Hüls,
1993b). 24 h after instillation, the substance was removed by washing
with water. 1, 24, 48 and 72 h later the eyes were examined and scored.
As a result, the mean scores for cornea, iris, conjunctivae and chemosis
were all 0 in all animals. Thus, no irritation to eyes was found.
A further eye irritation study was performed with glycerides, mixed
decanoyl and octanoyl according to EPA OPP 81-4 and in compliance with
GLP (Safepharm, 1988b). The undiluted test substance (0.1 mL) was
instilled into the conjunctival sac of one eye of six New Zealand White
rabbits. The eyes were examined and scored 1, 24, 48 and 72 h after
application. At the 1 h reading, iridial inflammation was observed in
1/6 animals, which was fully reversible within 24 h, while mild to
moderate conjunctivae effects were apparent in 6/6 animals. In 1/6
animals, mild conjunctivae redness and chemosis was still apparent after
24 h which was fully reversible at the 48 h reading. In the remaining
5/6 animals, conjunctivae irritation was fully reversible within 24 h.
No adverse corneal effects were noted in any animal at any observation
time point and no further local or systemic toxic effects were observed.
The mean scores for conjunctivae and chemosis were 0.06 for all six
animals. The effects on cornea and iris after 24, 48, and 72 h were
scored 0 for all six animals. Thus, no irritation to eyes was found.
In conclusion, the available data on the skin and eye irritation
potential of propane-1,2,3-triyl 2-ethylhexanoate and structural
analogue substances indicate that propane-1,2,3-triyl 2-ethylhexanoate
is not irritating to the skin and eye.
A detailed reference list is provided in the technical dossier (see
IUCLID, section 13) and within the CSR.
Based on test substance data and read-across from structurally similar
substances, the available data on skin and eye irritation do not meet
the classification criteria according to Regulation (EC) No. 1272/2008,
and 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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