Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-02-25 to 2005-06-16

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:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

adopted: 1992-07-17

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Version / remarks:

cited as :directive 96/54/EG, B.6

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Version / remarks:

adopted: 1996-08

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A reliable test method (guinea pig maximisation test) was already performed to fulfill the data requirements of this endpoint.

Test material

Test material information

Constituent 1

Reference substance name:

Different oligomers of 1,1,1-tris-(omega-(2,2-dimethyl-3-lauroyloxypropylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Molecular formula:

C57H107N3O6 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1,1,1-tris-(omega-(2,2-dimethyl-3-lauroyloxypropylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Constituent 2

Reference substance name:

Different oligomers of 1,1-Bis(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino))-poly(oxy(methyl-1,2-ethanediyl))methyl)-1-(omega-hydroxy-poly(oxy(methyl-1,2-ethandiyl))-methyl)propane

Molecular formula:

C40H76N2O5 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1,1-Bis(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino))-poly(oxy(methyl-1,2-ethanediyl))methyl)-1-(omega-hydroxy-poly(oxy(methyl-1,2-ethandiyl))-methyl)propane

Constituent 3

Reference substance name:

Different oligomers of 1-(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-1-bis-(omega-hydroxy-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Molecular formula:

C23H45N1O4 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1-(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-1-bis-(omega-hydroxy-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Constituent 4

Reference substance name:

"unknown" (oligomers)

Molecular formula:

no data

IUPAC Name:

"unknown" (oligomers)

Constituent 5

Reference substance name:

-

EC Number:

468-880-2

EC Name:

-

Cas Number:

102985-93-3

Molecular formula:

C17H32O3

IUPAC Name:

2,2-dimethyl-3-oxopropyl dodecanoate

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: LAB-ALL Bt. Budapest, 1174 Hunyadi u. 7.
- Weight at study initiation: Weights of study animals varied less than ± 20 % of mean weight.
- Housing: Animals were housed in macrolon cages, size III., with 3 or 2 animals/cage (42 x 42 x 19 cm)
- Diet : Animals received PURISTAR standard diet for rabbits produced by AGRIBRANDS Europe Hungary, 7400 Kaposvär, Domböväri üt, ad libitum.
- Water : The animals received tap water, as for human consumption, ad libitum supplemented with 50 mg/100 mL Ascorbic acid.
- Acclimation period: 29 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12 air exchange/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12 hours daily from 6 a.m. to 6 p.m. (artificial light)

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: oleum helianthi

Concentration / amount:

Concentration of test material and vehicle used at induction: Day 0: Test group: 2 injections 0.1 mL with 1 % test item homogenized in oleum helianthi and 2 injections 0.1 mL with 1 % test item mixed with physiological saline solution and homogenized in Freund's complete adjuvans. Control group: treated like test group without test item.
Day 6:
24 h before second study 0.5 mL 10 % sodium dodecyl sulphate in vaseline was applicated on test areas of all animals in order to create local irritation. second stage, topical application Day 7: Test group: 0.5 ml of undiluted test item Control group: 0.5 mL vehicle (oleum helianthi) Concentration of test material and vehicle used for each challenge:
Day 21: Test and control group: A patch loaded with undiluted test item in oleum helianthi was applied on the left flank of the animals and a patch loaded with 0.5 mL oleum helianthi (vehicle) to the right flank (intraspecific control).

Challenge

Route:

intradermal and epicutaneous

Vehicle:

other: oleum helianthi

Concentration / amount:

Concentration of test material and vehicle used at induction: Day 0: Test group: 2 injections 0.1 mL with 1 % test item homogenized in oleum helianthi and 2 injections 0.1 mL with 1 % test item mixed with physiological saline solution and homogenized in Freund's complete adjuvans. Control group: treated like test group without test item.
Day 6:
24 h before second study 0.5 mL 10 % sodium dodecyl sulphate in vaseline was applicated on test areas of all animals in order to create local irritation. second stage, topical application Day 7: Test group: 0.5 ml of undiluted test item Control group: 0.5 mL vehicle (oleum helianthi) Concentration of test material and vehicle used for each challenge:
Day 21: Test and control group: A patch loaded with undiluted test item in oleum helianthi was applied on the left flank of the animals and a patch loaded with 0.5 mL oleum helianthi (vehicle) to the right flank (intraspecific control).

No. of animals per dose:

Number of animals in test group: 10
Number of animals in negative control group: 5

Details on study design:

A total of 10 test animals were subjected to sensitisation procedures in a two-stage operation, i.e. an intra-dermal treatment and a topical application. The test item was administered at a concentration of 1 % for intra dermal injections and in undiluted state for dermal sensitisation treatments. The test area was painted with 0.5 ml of 10 % sodium dodecyl sulphate in vaseline 24 h prior to the topical induction application in order to create a local irritation. Two weeks following the last induction exposure a challenge dose (in undiluted state) was administered. Challenge was performed by dermal application of the test item.

Challenge controls:

Concurrent to treatment animals, 5 control guinea pigs were exposed to the vehicle only, during the sensitisation phase, and treated with the test item (in undiluted state) in challenge exposures.

Positive control substance(s):

yes

Remarks:

potassium dichromate

Results and discussion

Positive control results:

In the test group 10 animals were treated with the reference item. After the challenge with the reference item POTASSIUM DICHROMATE, positive response was seen in five out of ten animals in the test group (50 %). The dermal lesions represented patchy and confluent erythema developed on the skin of sensitised guinea pigs (score 2). On the opposite (right) side treated with vehicle only, no skin sensitisation reaction was found. A total of 5 control animals was exposed to vehicle for induction treatments and exposed to the reference item for challenge application. No visible changes were recorded 24 hours and 48 hours after challenge application. Challenge application of reference item POTASSIUM DICHROMATE (in concentration of 0.3 %) did not cause primary skin irritation.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

not applicable

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

other: no positive control group required.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

not applicable

No. with + reactions:

0

Total no. in group:

0

Remarks on result:

other: no positive control group required

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100 %

No. with + reactions:

1

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.

Results 4

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 5

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Results 6

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Sika Hardener LTJ was classified as non-sensitiser based on this guinea pig maximisatzion test and according to Regulation (EC) 1272/2008.

Executive summary:

A study was conducted according to OECD TG 406 and directive 96/54/EG method B6. Challenge application of test item Sika Hardener LTJ resulted in a positive response in 10 % of the test animals previously sensitised. The dermal scores represented discrete erythema developed on the skin of a sensitised guinea pig (score 1). Control animals showed no signs of skin irritation 24 hours and 48 hours after challenge applications. Thus, the test item Sika Hardener LTJ was classified as a non-sensitiser, based on this guinea pig maximisation test and according to Regulation (EC) No 1272/2008.