Registration Dossier

Administrative data

Description of key information

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.

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-06-27 to 2005-09-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sandor Breeder; 2173 Kartal; Vörös Hadsereg Street 131; Hungary;
- Age at study initiation: 11 weeks;
- Weight at study initiation: 2918 - 3157 g;
- Housing: individually in metal cages;
- Diet: PURISTAR Standard Diet for Rabbits; AGRIBRANDS Europe Hungary PLC; H5300 Karcag, Madarasi road; Hungary; ad libitum;
- Water: tap water ad libitum;
- Acclimation period: 8 days;

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: 8 - 12 air changes/hr by central air-condition system;
- Photoperiod: 12 hrs dailiy from 6.00 a.m. to 6.00 p.m.;

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin of each animal served as control.
Amount / concentration applied:
0.5 mL of test item applied in a single dose;
Duration of treatment / exposure:
4 hours;
Observation period:
1 hour, 24, 48 and 72 hours
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: plastic wrap

OBSERVATION TIME POINTS
- 1 hour, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: according to guideline
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
11368/M
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
11325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
11389/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
11368/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
11325/M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One hour after the patch removal, one animal (no. 11368) developed very slight erythema on the treated skin surface (score 1). The other two animals (No. 11325, 11389) developed no primary irritation symptoms, such as erythema and oedema, or other adverse effects during the observation period, either at the treatment or the control application areas.
Other effects:
NA
Interpretation of results:
GHS criteria not met
Conclusions:
The test item SIKA Hardener LH is not considered to be irritant to rabbits' skin.
Executive summary:

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 alterations.

No skin irritation properties were found in the test with Sika Hardener LH.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-11-04 to 2004-10-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: 10 weeks
- Weight at study initiation: 2594-2823 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes were examined at 1, 24, 48, and 72 hours after the application.
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
The eye irritation scores will be evaluated according to the scoring system by Draize (1959) and OECD 405 (24 April 2002)

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One hour after treatment some hyperaemic blood vessels occurred in every animal. In two animals (animal No.: 16782, 17060) the discharge with moistening of the lids and hairs just adjacent to lids was found. In one case (animal No.: 16712) the discharge moistened the lids and considerable area around the treated eye. Chemosis, corneal and iris alterations were not found during the study. 24 hours after treatment in two animals (animal No.: 16712, 17060) some hyperaemic blood vessels occurred. In animal No.: 16712 the discharge from the eye was “any amount different from normal”. The animal No.: 16782 became fully symptom-free by this time. 48 and 72 hours after treatment every animal was symptom-free.
Other effects:
None.
Interpretation of results:
GHS criteria not met
Conclusions:
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 48h. 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.
Executive summary:

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.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached "Read-Across" Justification.
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin 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.

Eye irritation

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

Hexamethylenediamine: irritating

Respiratory irritation

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).

Justification for classification or non-classification

Based on 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 (CLP).