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EC number: 479-930-8
CAS number: 613222-52-9
SIKA Hardener LH was tested for skin irritation properties according to EU method B.5 and OECD guideline 405 and did not show skin irritation properties. The test on eye irritation was waived for animal welfare reasons. Based on irritating/corrosive properties of diamines, SIKA Hardener LH was considered irritating to eyes. In analogy with the hydrolysis product hexamethlyendiamine the substance was classified as respiratory irritant.
Sika Hardener LH (VP) was tested for skin
irritation properties in a study with albino New Zealand White rabbits.
The test material was applied to the intact skin of rabbits as a single
dose of 0.5 mL. The irritation symptoms were examined at 1, 24, 48 and
72 hours after the patch removal. In one animal, very slight erythema
were recorded 24 and 48 hours after patch removal (score 1), on the
treated skin surface. All animals were free of irritation symptoms
(erythema and oedeme) 72 hours after patch removal. Thus, the study was
terminated after 72 hours.
The animals' individual mean scores
(considering readings at 24, 48 and 72 hours after patch removal) for
erythema and oedema were 0.66. 0.00 and 0.00 and 0.00, 0.00 and 0.00
respectively. The observed symptoms were evaluated as fully reversible
No skin irritation properties were found in
the test with Sika Hardener LH.
The acute eye irritation study of the test
item 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 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.
SIKA Hardener LH was tested for skin irritation properties according to EU method B.4 and OECD guideline 404. In a study with albino New Zealand White rabbits test material was applied to the intact skin as a single dose of 0.5 mL. Irritation symptoms were examined at 1, 24, 48 and 72 hours after patch removal. In one animal, very slight erythema were recorded 24 and 48 hours after patch removal (score 1), on the treated skin surface. All animals were free of irritation symptoms (erythema and oedeme) 72 hours after patch removal. Thus, the study was terminated after 72 hours. The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.66. 0.00 and 0.00 and 0.00, 0.00 and 0.00 respectively. The observed symptoms were evaluated as fully reversible alterations. SIKA Hardener LH was not considered to be irritating to skin.
SIKA Hardener LH is the reaction product of the two substances 2,2-Dimethyl-3-lauroyloxy-propanal (CAS no. 102985-93-3, EINECS no. 468-880-2) and Hexamethylenediamine (CAS no. 124-09-4, EINECS No. 204-679-6). Upon contact with water SIKA Hardener LH rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. As agreed with the German Authorities (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA, see IUCLID section 13) the test on eye irritation was waived for animal welfare reasons. Instead, available data for hydrolytic degradation products 2,2-Dimethyl-3-lauroyloxy-propanal and Hexamethlendiamine are provided. Based on irritating/corrosive properties of diamines SIKA Hardener LH was considered irritanting to eyes. SIKA Hardener LH hydrolysis products reveal the following eye irritating properties:
Dimethyl-3-lauroyloxy-propanal: not irritating to eyes
The substance SIKA Hardener LH hydrolyses very fast into Dodecanoic acid, 2,2-dimethyl-3-oxopropyl ester (“Aldehyde L”, CAS 102985-93-3, EC 468-880-2) and Hexamethylenediamine (“HMD”,CAS 124-09-4, EC 204-679-6). Whereas Aldehyde L is absolutely uncritical with regard to local irritation (see disseminated dossier published on the ECHA homepage, submitted by Incorez Ltd.), hexamethylendiamine is the hydrolysis product of concern regarding respiratory irritation (see disseminated dossier of hexamethyldiamine, published on the ECHA homepage). In analogy with this hydrolysis product the substance SIKA Hardener LH is classified as STOT SE cat. 3 according to Regulation (EC) No 1272/2008 (CLP).
data available on irritation/corrosion properties, SIKA Hardener LH was
classified for eye irritation/corrosion cat. 1 (H318: causes serious eye
damage) and as STOT SE cat. 3 (H335: May cause respiratory irritation) according
to Regulation (EC) No 1272/2008, as amended for the fifteenth time in
Regulation (EU) No 2020/1182.
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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