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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 30, 2006 to September 23, 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 406, EU Method B.6 and EPA OPPTS 870.2600 Method, in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lab-All Bt. Budapest, 1174 Hunyadi u. 7.
- Date of receipt: August 16, 2006
- Body weight range at the beginning of the study: 360-399 g
- Sex: Male.
- Housing: Animals were housed in macrolon cages, size III., with 3 or 2 animals/cage (42 x 42 x 19 cm)
- Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasern
- Diet: Purina Base – Lap gr. diet for rabbit produced by Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: Tap water, ad libitum containing 50 mg/100 mL Ascorbic acid.
- Animal health: Only animals in acceptable health condition were used for the test. It was certified by the veterinarian.
- Acclimation period: 14 d
- Animal identification: The animals were marked individually with ear punching. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal numbers.
- Randomisation: All animals were sorted according to weight on the day before the start of the treatment period. After this the animals were allocated to the test groups. The result of the randomisation was checked according to the actual body weights assuring an acceptable homogeneity and variability among the groups.
- Body Weight: The body weights of individual animals were recorded at the beginning and at the end of the experiment. The mean values and the standard deviations were calculated in the test group as well as in the control.

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: August 30, 2006 to September 23, 2006
Route:
intradermal and epicutaneous
Vehicle:
other: physiological saline solution (i.e., NaCl 0.9 %) and Freund's complete adjuvant (i.e., FCA) were used for the intradermal applications and physiological saline solution for the dermal applications
Concentration / amount:
Induction:
Concentration for intradermal injection: 5%
Concentration for dermal application: 20%

Challenge:
Concentration for dermal application: 25%
Route:
epicutaneous, occlusive
Vehicle:
other: physiological saline solution (i.e., NaCl 0.9 %) and Freund's complete adjuvant (i.e., FCA) were used for the intradermal applications and physiological saline solution for the dermal applications
Concentration / amount:
Induction:
Concentration for intradermal injection: 5%
Concentration for dermal application: 20%

Challenge:
Concentration for dermal application: 25%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in control group: 5
Details on study design:
Main Study
Induction involved two main procedures: intra-dermal treatments (i.e., Main Study I) and dermal exposure (i.e., Main Study II) with closed patch technique. The intra-dermal and the dermal induction treatments were observed and recorded.

Main Study I: Intra-dermal Induction Exposure
Before starting the exposure an area of approximately 5 x 5 cm on the scapular region of animals was clipped free of hair and shaven close with care.
Intra-dermal treatment
Test groups: A row of three injections, six in all, was made on each side of test animals, as follows:
2 injections with 0.1 mL of Freund's complete adjuvant (i.e., FCA) mixed with physiological saline solution (1:1),
2 injections with 0.1 mL of the test substance (i.e., 5%) homogenized in physiological saline solution,
2 injections with 0.1 mL of test substance (i.e., 5%) mixed with physiological saline solution and homogenized in Freund's complete adjuvant (1:1).
Control group: The control animals were treated similarly as the test group however, the vehicle, without the test substance was used for injections, as follows:
2 injections with 0.1 mL mix of Freund's complete adjuvant and physiological saline solution (1:1)(v/v),
2 injections with 0.1 mL of physiological saline solution,
2 injections with 0.1 mL of 50% w/v physiological saline solution, in a 1:1 mixture (v/v) of Freund's complete adjuvant and physiological saline solution.

Main study II: Dermal Induction Exposure
6 d after the intra-dermal injections, in all animals the test area was painted with 0.5 mL of 10% sodium dodecyl sulphate in Vaseline 24 h prior to topical induction application, in order to create a local irritation.
Approximately 24 h after the painting, the test animals were exposed to test substance on the other hand the control animals were treated with physiological saline solution, as vehicle.
Closed patch was applied in the following manner: in case of the test animals 0.5 mL of test substance (i.e., at concentration of 20%) was spread on the surface prepared previously and covered with a standard (i.e., 5x5 cm) size of porous gauze patch.
Control animals were treated dermally with 0.50 mL of physiological saline solution, as vehicle and the dressing was prepared and applied as for the test animals.
The exposed areas were covered for 48 h with porous gauze fastened with "Leucoplast" (i.e., closed Patch Test).

Main study III: Challenge Exposure
Two weeks after the dermal treatment the animals were exposed to the challenge dose, dermally. 24 h before the challenge treatment the left and the right flank areas (i.e., 5x5 cm) of each animal were prepared for application. The challenge was performed as a dermal exposure (i.e., closed Patch Test).
Left shaved flank areas of the animals (i.e., both the test and the control) were treated with 0.5 mL of the test substance at concentration of 25%. The test substance coloured to the treated skin surface, for this reason the right sides of animals (i.e., both the test and the control) were treated with a safeguard doses at concentrations of 12.5%. Implementation was done as described above in ‘Main study II: Dermal Induction Exposure’. Time of exposure was 24 h.
OBSERVATION AND SCORING The dermal irritation scores (i.e., in case of the preliminary study (primary irritation) and in cases of induction dermal exposures) were evaluated according to the scoring system by Draize (1977).
Positive control substance(s):
yes
Remarks:
(2-mercaptobenzothiazole tested in another study)
Positive control results:
After the challenge treatment positive response was observed in 60% of the treated animals
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% and 12.5% (i.e., safeguard dose) dermal application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application . No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% and 12.5% (i.e., safeguard dose) dermal application
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: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control
Dose level:
25% and 12.5% (i.e., safeguard dose) dermal application
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control
Dose level:
25% and 12.5% (i.e., safeguard dose) dermal application
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 25% and 12.5% (i.e., safeguard dose) dermal application. No with. + reactions: 0.0. Total no. in groups: 5.0.

MAIN STUDY

Test group

After the challenge with test substance at concentration of 25% and 12.5% (i.e., as safeguard dose), positive response was not observed on the animals of the test group. The mean of the scores was 0.00 according to the 24 and 48 h results.

Control group

Five control animals were exposed to vehicle during induction treatments and they were treated with the test substance on the challenge day only. No visible changes were found at the 24 and 48 h examinations. During the challenge exposure, the test substance at concentration of 25% and 12.5% (i.e., as safeguard dose) did not evoke primary irritation.

BODY WEIGHT

The individual body weights of the guinea pigs were measured at the beginning and at the end of experiment. There were no notable differences between the test animal group and the control group.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the test substance showed no evidence of sensitizing properties.
Executive summary:

A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, EPA OPPTS 870.2600 and EU Method B.6, in compliance with GLP.

Based on the results of a preliminary study, 5 and 20% of test substance in physiological saline solution were selected as intradermal and dermal induction doses. The concentration used for challenge application was 25% test substance in physiological saline solution. Further, as test substance coloured the treated skin surface, the other side of animal (both the test and the control) was treated with a safeguard dose at a concentration of 12.5% in physiological saline solution during challenge exposure.

None of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.

Under the study conditions, the test substance showed no evidence of sensitizing properties.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406, EPA OPPTS 870.2600 and EU Method B.6, in compliance with GLP.

Based on the results of a preliminary study, 5 and 20% of test substance in physiological saline solution were selected as intradermal and dermal induction doses. The concentration used for challenge application was 25% test substance in physiological saline solution. Further, as test substance coloured the treated skin surface, the other side of the animal (both the test and the control) was treated with a safeguard dose at a concentration of 12.5% in physiological saline solution during challenge exposure. None of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. Under the study conditions, the test substance showed no evidence of sensitizing properties (Stahl, 2006c).


Justification for selection of skin sensitisation endpoint:
Guideline-compliant study conducted according to GLP.

Justification for classification or non-classification