Dodecanoic acid, 1,1'-[1,6-hexanediylbis[nitrilo(2,2-dimethyl-1-propanyl-3-ylidene)]] ester

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

479-930-8

EC Name:

-

Cas Number:

613222-52-9

Molecular formula:

C40H76N2O4

IUPAC Name:

(3E)-3-({6-[(E)-[3-(dodecanoyloxy)-2,2-dimethylpropylidene]amino]hexyl}imino)-2,2-dimethylpropyl dodecanoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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.

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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.

Applicant's summary and conclusion

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.