Registration Dossier

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:
1997-10-27 to 1997-10-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study
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
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
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
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
Positive control results:
Not applicable
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..

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

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A dermal sensitization study was conducted acording to OECD 406 with this test substance in guinea pigs using the footpad method. In a primary irritation screen, three animals were administered 10% of the test substance in a vehicle of acetone, dioxane, and guinea pig fat (7:2:1) topically. No signs of irritation were noted at 24 or 48 hours after administration of the test substance; therefore, the concentration used in the challenge dose of the sensitization study was set at 10% of the test substance in the vehicle. In the sensitization study, no dermal responses were noted for the ten animals previously induced with Freund's Complete Adjuvant (FCA) (control animals) or for the ten animals previously induced with 1% of the test substance in FCA (test animals). All animals in both groups were graded as having no response to the test substance after the challenge application. Based on these results, the test substance was not considered to be a dermal sensitizer in guinea pigs. The Iack of any respons at challenge indicates that the test substance is not a skin senitiser.


Migrated from Short description of key information:
A dermal sensitization study conducted acording to OECD 406 in guinea pigs indicates that the test substance is not a skin senitiser.

Justification for selection of skin sensitisation endpoint:
GLP and guideline compliant study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data the test item has no sensitisation potential and was thus not classified and labelled according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC (DSD).