Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-10-27 to 1997-10-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
, adopted 1981
Deviations:
yes
Remarks:
induction step via injection in the footpad
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Crl:(HA)BR VAF/Plus
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: for primary irritation portion: 8 - 9 weeks, for induction and challenge: 4 to 5 weeks
- Weight at study initiation: 304 to 353 g
- Housing: singly, stainless-steel, wire mesh cages
- Diet: PMI Certified Guinea Pig Diet (5026) was available ad libitum
- Water: Public drinking water, regulary asessed, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-22 °C
- Humidity: 52-53 %
- Photoperiod: 12 hours of artificial light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: injected in the footpad
Vehicle:
other: acetone, dioxane, and guinea pig fat (7 :2: 1)
Concentration / amount:
Induction - 1 % v/v in Freunds Complete Adjuvant (FCA)
Challenge - 10 % v/v in vehicle
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone, dioxane, and guinea pig fat (7 :2: 1)
Concentration / amount:
Induction - 1 % v/v in Freunds Complete Adjuvant (FCA)
Challenge - 10 % v/v in vehicle
No. of animals per dose:
3 male animals for the irritation study
10 male animals for the induction and challenge study
10 male animals for the control group
Details on study design:
Preliminary :
Animals that were previously exposed to FCA were tested for primary skin irritation. Hair was removed from the backs of the animals with an electric clipper and 0.3 mL of a 10% solution of the test compound in the vehicle was applied to the clipped area. Twenty-four hours later, the animals were depilated and scored for edema and erythema. The skin reaction was also scored at 48 hours. The highest average score for either day determined the concentration to be used in the challenge dose of the main study. The challenge dose was based on the highest concentration of the test substance (up to 10%) that produced no irritation for any of the three animals of a dose group in the primary irritation screen.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 footpad injection per animal
- Test groups: 10 male animals
- Control group: 10 male animlas receiving FCA
- Site: Footpad
- Frequency of applications: one
- Duration: 7 day waitng period until start of challenge
- Concentrations: 1 % v/v in Freunds Complete Adjuvant (FCA)

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 7 days after the final induction
- Test groups: 10 male animals
- Control group: 10 male animals
- Site: dorsal region
- Concentrations: 10 v/v in vehicle
- Evaluation: 24 and 48 after challenge
Challenge controls:
The control animals were induced with 0.05 mL FCA only and challenged in the same way as test groups.
Positive control substance(s):
not required

Results and discussion

Positive control results:
Not applicable

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..

Any other information on results incl. tables

Degree and Nature of lrritation in the prelimiary study

In the primary irritation screen no signs of irritation were noted. In the sensitization study, no dermal responses were noted for the ten animals previously induced with FCA (control animals) or for the ten animals previously induced with 1% of the test substance in FCA (test animals). Based on these results, the test animals were graded as having no sensitization response to the test substance after the challenge application.

Sensitization

No sensitization reactions were observed. All respective erytheme and edema were 0.

Toxic effect other than irritation

No toxic effects or systemic clinical signs were noted during the study.

Body Weights

All animals gained weight during the study

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information