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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-03-03 - 2005-03-27
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 17th 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
July 30th 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
August 1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The guinea pig maximisation test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Reference substance name:
-
EC Number:
479-940-2
EC Name:
-
Cas Number:
613246-75-6
Molecular formula:
NA: Multi-const. substance
IUPAC Name:
16-(dodecanoyloxy)-2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-dien-1-yl dodecanoate
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest, 1174 Hunyadi u. 7.
- Housing: Animals were housed in macrolon cages (42 x 42 x 19 cm), with 3 or 2 animals/ cage
- Diet: PURISTAR standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 29 days

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Oleum helianthi
Concentration / amount:
intra-dermal Induction: 0.1 mL of the test item (5%) homogenized in oleum helianthi
dermal induction: 0.5 mL of test item (in undiluted state)
challenge: 0.5 mL of test item (in undiluted state)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Oleum helianthi
Concentration / amount:
intra-dermal Induction: 0.1 mL of the test item (5%) homogenized in oleum helianthi
dermal induction: 0.5 mL of test item (in undiluted state)
challenge: 0.5 mL of test item (in undiluted state)
No. of animals per dose:
test group: 10 animals treated with test item, 10 animals treated with reference material
control group: 5 animals treated with test item, 5 animals treated with reference material
Details on study design:
RANGE FINDING TESTS:
In order to specify primary irritation by intra-dermal injection and dermal application a series of four dose levels each were tested. For intra-dermal injections the test item was injected at concentrations of 0.01, 0.1, 1, and 5 % (w/v). The dermal applications were conducted with 25, 50, 75% (w/v) and an undiluted state. 0.1 mL of the test item was used as test volume for injection and 0.5 mL were used for the dermal application.
As a result of these preliminary testings, the test item was formulated and used at a concentration of 5% for intra-dermal treatment and used in undiluted state for dermal induction treatment and challenge application.

MAIN STUDY

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 5% for intradermal 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 24h 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:
Control animals were treated similarly to test animals, except that the test item was omitted in the induction phase.
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 responses were seen in five out of ten animals in the treatment group (50%). Dermal scores represented patchy and confluent erythema, which had developed on the skin of sensitised guinea pigs (score 2). The opposite (right) flanks of animals, treated with vehicle only, showed no reaction. Five control animals were exposed to the vehicle of induction treatment and treated with the reference item for the challenge. No visible changes were recorded 24 hours and 48 hours after challenge initiation. During challenge exposure, the reference item potassium dichromate (in concentration of 0.3 %) did not evoke primary irritation.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3 % potassium dichromate
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
patchy and confluent erythema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3% potassium dichromate
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
patchy and confluent erythema
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
patchy erythema
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
patchy erythema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the findings in this guinea pig maximisation test Sika Hardener LJ is not sensitising to the skin.
Executive summary:

A guinea pig maximisation test (GPMT) was performed with a total of 10 guinea pigs according to the Magnusson-Kligman method, using Freund's complete adjuvant technique, to evaluate the sensitisation potential of test item Sika Hardener LJ. The undiluted test substance was applied topically to the intact skin of 10 (test group) respectively 5 (negative control group) rabbits after intra dermal induction by 5% dilution of the test substance (test group) or the vehicle only (negative control group). 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 the challenge dose (in undiluted state) was administered. The results were read after 24h and 48h. Positive responses were observed in 20 % of the test animals after challenge with the test item. Challenge with the test item elicited patchy erythema on the skin surface of previously sensitised guinea pigs (score 1). There were no responses indicating skin sensitisation in the negative control group. Based on these findings the test substance is not sensitising to the skin. (LAB, 2005)