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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study is available and assessed reliable and sufficient to meet the information requirements.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Kreis Pderborn, Germany
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: mean 352 g
- Housing: Makrolon cages type IV
- Diet: Altromin3022 ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2 °C
- Humidity (%): 50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
intradermal induction: 5 %
epicutaneous induction: 50 %
Challenge: 6 %
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
intradermal induction: 5 %
epicutaneous induction: 50 %
Challenge: 6 %
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS: yes:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal on start, epicutaneous one week later
- Test groups: 20 animals
- Control groups: 2*10 animals
- Site: on the back
- Frequency of applications: once intradermal, once epicutaneous
- Duration: 48 hours for epicutaneous
- Concentrations: 5 % and 50 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: on the back
- Concentrations: 6 %
- Evaluation (hr after challenge): 24 and 48 h after removal of bandage
Positive control substance(s):
no
Positive control results:
No
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
6 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
6 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item Tolyltriazole did not show any signs of skin sensitation in the guinea pig in this study.
Historical data of positive control substances showed the sensitivity of the test performed in the labouratry
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The substance is not skin-sensitising

Justification for selection of skin sensitisation endpoint:
Only one study available. This study is conducted following an OECD Guideline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The substance is not skin-sensitising. No information on respiratory sensitisation is available. The particle size distribution and vapour pressure lead to the conclusion, that no inhalable fraction is present. Together with the non-skin-sensitising property, it can be assumed that the substance is not repsiratory sensitising.

Justification for classification or non-classification