Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Preventol CI 7-100

- Substance type: cylindrical granules
- Physical state: solid
- Analytical purity: 99.2 %
- Composition of test material, percentage of components: 40 % 4-Methylbenzotriazole, 60 % 5-Methylbenzotriazole
- Lot/batch No.: 868
- Storage condition of test material: 20 - 22.5 °C in the dark

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
intradermal induction: 5 %
epicutaneous induction: 50 %
Challenge: 6 %
Challengeopen allclose all
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

Results and discussion

Positive control results:
No

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

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