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EC number: 700-071-4
CAS number: 932742-30-8
An acute eye irritation study with the test item SIKA Hardener LI was performed according to EU method B.5 and OECD guideline 405. SIKA Hardener LI was considered to not cause eye irritation in rabbits. The skin irritation study with SIKA Hardener LI was waived according to column 2 of REACH Annex XII section 8.1, as the acute dermal toxicity study (see section 7.2.1) did not indicate skin irritation up to the limit dose of 2000 mg/kg bw. Data from the hydrolysis products indicate that 2,2-Dimethyl-3-lauroyloxy-propanal is not irritating to skin and eye, but 3-aminomethyl-3,5,5-trimethylcyclohexylamine is classified as skin corrosive cat. 1B (see ECHA dissemination webpage). Nevertheless, data for the test item support the lack of irritating potential for SIKA Hardener LI and the effects of the amine are obviously not relevant for acute local effects in case of short time exposure to SIKA Hardener LI.
In a weight of evidence approach the
biodegradation data form the parent molecule and the two primary
hydrolysis products were assessed:
An acute eye irritation study with the
parent substance SIKA Hardener LI was performed according to EU method
B.5 and OECD guideline 405. Potential irritation effects were assessed
in three albino New Zealand White rabbits and test item exposures
evaluated by the Draize method. The test item was placed into the
conjunctival sac of the left eye of the animals. The untreated right eye
served as control. 0.1 mL of the test item was used for the study in its
pure state, as a single dose and were washed with physiological saline
at the end of the treatment.
One hour after application of the test item
SIKA Hardener LI, conjunctival redness and discharge was observed in all
animals. At 24 hours after the treatment conjunctival redness was found
in three animals. At 48 hours after the treatment, one animal showed
conjunctival redness. At 72 hours after treatment, full recovery was
observed in all animals and the study was terminated. The animal’s
individual mean scores (considering readings at 24, 48 and 72 hours
after the treatment) were as follows:
For animal 1: redness- 0.33, chemosis- 0.
iris- 0, cornea opacity- 0
For animal 2: redness- 0.67, chemosis- 0.
iris- 0.67 cornea opacity- 0
For animal 3: redness- 0.33, chemosis- 0.
iris- 0.67, cornea opacity- 0
During the study the control eyes of the
animals were symptom-free. The general state and the behaviour of the
animals were normal throughout the study period. Thus, SIKA Hardener LI
was considered to not cause eye irritation in rabbits.
The acute eye irritation study of the
hydrolysis product 2,2-Dimethyl-3-lauroyloxy-propanal was performed in
three New Zealand White rabbits. The irritation effect of the test item
was evaluated according to the Draize method (OECD No.: 405, 2002). The
test item was placed into the conjunctival sac of the left eye of each
animal. The untreated right eye served as control. The treated eyes of
the test animals were not washed out following the instillation of 0.1
mL of the test item, which was administered in pure state, in a single
dose. The eyes were examined at 1, 24, 48, and 72 hours after the
application. One hour after the single application of
2,2-Dimethyl-3-lauroyloxy-propanal into the eyes of the rabbits slight
redness and moderately or severely increased discharge were observed in
the eyes of the test animals. Chemosis, corneal and iris alterations
were not found during the study. 24 hours after treatment in two animals
slight redness was observed and in one case slightly increased discharge
was noted. One animal became fully symptom-free by this time. 48 hours
after the treatment every animal was symptom-free. 72 hours after the
treatment the study was terminated, since no primary irritation symptoms
occurred. The general state and the behaviour of animals were normal
during the whole study. In conclusion, the test item
2,2-Dimethyl-3-lauroyloxy-propanal, applied to the rabbits' eye mucosa,
caused irritant effects, which can be evaluated as fully reversible
alterations within 48 h. According to the EU (DSD and GHS) criteria for
classification and labelling requirements for dangerous substances and
preparations the test item does not have to be classified and has no
obligatory labelling requirement for eye irritation.
Isophorone diamine, the second hydrolysis
product, was investigated for irritant effects on the eye and associated
mucous membranes of 1 female rabbit according to OECD TG 405 (1981). The
test substance was applied in a single dose of 0.1 ml into the
conjuntival sac of the animal. The undiluted substance produced serious
injury almost immediately after application (corrosive effects,
opalescence). 24 hours after treatment conjunctiva showed necrosis. Due
to the corrosive effect of the test material, only 1 animal was used and
the experiment terminated after 24 hours.The lesions were not
reversible. Therefore Isophorone diamine has to be considered to be
corrosive and to cause irrivrsible damage to the eyes (see ECHA
A study on skin irritation with the parent
product SIKA Hardener LI was waived according to column 2 of REACH Annex
XII section 8.1, as the acute dermal toxicity study (see section 7.2.1)
did not indicate skin irritation up to the limit dose of 2000 mg/kg bw.
The acute skin irritation study of the
hydrolysis product 2,2-Dimethyl-3-lauroyloxy-propanal was performed in
New Zealand White rabbits. The irritation effect of the test item was
evaluated according to the Draize method (OECD No.: 404, 2002). The test
item was administered in a pure state, as a single dose of 0.5 mL, to
the shaved skin of all experimental rabbits. The untreated skin of each
animal served as control. After 4 hours any remaining test item was
removed with water at body temperature. The animals were examined at 1,
24, 48 and 72 hours after the patch removal. No irritation symptoms
(erythema and oedema) or other signs occurred after the patch removal
and during the 72-hour observation period, so the study was terminated
at the 72nd hour. During the study the behaviour and general state of
animals were normal. The animal’s individual mean scores (considering
readings at 24, 48 and 72 hours after patch removal) for erythema and
oedema were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00 respectively. Thus,
the classification of the test item 2,2-Dimethyl-3-lauroyloxy-propanal
as a skin irritant is not required.
In a study with 6 adult rabbits 0.5 ml
undiluted 3-aminomethyl-3,5,5-trimethylcyclohexylamine (Isophorone
diamine), the second main hydrolysis product, was applied to the shorn
dorsal skin of the animals ( intact and scarified) and covered with
gauze and adhesive tape for 24 hours. The results were assessed at patch
removal (24h) and 48 hr later (72 h), the skin had become hard and
leatherlike. Edema scoring was not possible. Similar severity of effects
was observed at both readings, i.e. there was no indication of
reversibility within the observation period. In the study Isophorone
diamine is described to be a severe irritant according to the scoring
system used. Thus, under the conditions and according to the results of
this study isophorone diamine has to be considered to be corrosive to
the skin of rabbits (see ECHA dissemination webpage).
Based on the results of eye and skin
irritation studies, SIKA Hardener LI is not classified and labelled as
an eye or skin irritant according to Directive 67/548/EEC (DSD) and to
Regulation (EC) No 1272/2008 (CLP).
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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