Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-

Endpoint summary

Description of key information

The test substance Sika Hardener LJ was tested for skin irritation according to EU method B.5 and OECD guideline 405 and was not irritating to the skin of New Zealand white rabbits. In accordance with REACH Annex VII, column 2, the test on eye irritation was waived for animal welfare reasons. Based on the irritating/corrosive properties Sika Hardener LJ was considered irritating to the eye.

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:

2005-07-20 - 2005-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24th 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

May 31st 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: 11 weeks old
- Weight at study initiation: 3044 - 3293 g
- Housing: individually in metal cages
- Diet: PURISTAR standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

1h, 24h, 48h, 72h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: with water ( heated to body temperature)
- Time after start of exposure: 4h

SCORING SYSTEM:
- according to the scoring system by Draize (1959)

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Remarks on result:

other: after 1 h well defined erythema, after 24h slight erythema

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Remarks on result:

other: after 1 h well defined erythema

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Remarks on result:

other: after 1h slight erythema

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not irritating to the skin of New Zealand white rabbits.

Executive summary:

The acute skin irritation study of Sika Hardener LJ was performed in albino 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 (heated to body temperature). The animals were examined at 1, 24, 48 and 72 hours after the patch removal. One hour after the patch removal two animals developed well defined erythema (score 2) and in one animal very slight erythema (score 1) occurred on the treated skin surface. No oedema or other adverse effects were observed during the observation period, either at the treatment or the control application areas. At 24 hours after patch removal, one animal showed slight erythema on the treated skin surface (score 1). At 48 hours after patch removal no irritation symptoms (erythema and oedema) were recorded for any of the animals. The study was terminated after 72 hours. During the study behaviour and general state of animals were normal. The animals' individual mean scores (readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.33, 0.00 and 0.00 and 0.00, 0.00 and 0.00, respectively. Therefore the test item Sika Hardener LJ does not classify as a skin irritant. (LAB International Hungary Ltd., 2005)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Sika Hardener LJ is a reaction product of the two substances 2,2-Dimethyl-3-lauroyl-propanal (CAS no. 102985-93-3) and Polyetheramin D 230 (CAS no. 9046-10-0). Upon contact with water SIKA Hardener LJ rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. Because of the expected irritating/corrosive properties of the polyamine, Sika Hardener LJ is labelled with cat. 1, H318 (CLP) due to its alkali properties.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

The acute skin irritation study of Sika Hardener LJ was performed in albino 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 (heated to body temperature). The animals were examined at 1, 24, 48 and 72 hours after the patch removal. One hour after the patch removal two animals developed well defined erythema (score 2) and in one animal very slight erythema (score 1) occurred on the treated skin surface. No oedema or other adverse effects were observed during the observation period, either at the treatment or the control application areas. At 24 hours after patch removal, one animal showed slight erythema on the treated skin surface (score 1). At 48 hours after patch removal no irritation symptoms (erythema and oedema) were recorded for any of the animals. The study was terminated after 72 hours. During the study behaviour and general state of animals were normal. The animals' individual mean scores (readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.33, 0.00 and 0.00 and 0.00, 0.00 and 0.00, respectively. Therefore the test item Sika Hardener LJ does not classify as a skin irritant.

Eye irritation

Sika Hardener LJ is a reaction product of the two substances 2,2-Dimethyl-3-lauroyl-propanal (CAS no. 102985-93-3) and Polyetheramin D 230 (CAS no. 9046-10-0). Upon contact with water SIKA Hardener LJ rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. Because of the expected irritating/corrosive properties of the polyamine, Sika Hardener LJ is labelled with eye damage cat. 1, H318 (CLP) due to its alkali properties.

Justification for classification or non-classification

Based on the results of the acute skin irritation study Sika Hardener LJ is not subjected to classification and labelling for skin irritating effects according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182. Based on the alkali properties of the hydrolysis product Polyetheramin D 230 Sika Hardener LJ is classified as eye damaging cat. 1 (H318) according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.