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Toxicological information

Skin sensitisation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was performed in 1988.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granules
Details on test material:
Trade Name: Preventol CI-8
Purity: 99.83 %
- Name of test material (as cited in study report): Benzotriazol Granulat (Preventol CI-8)
- Substance type: pale yellow granules
- Physical state: solid
- Analytical purity: 99.83 %
- Purity test date: 20.5.1986
- Lot/batch No.: 909
- Storage condition of test material: at 20.5 - 23 °C in the dark
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: DHPW
Sex:
male
Details on test animals and environmental conditions:
animal number = 20
contol animal number = 10
TEST ANIMALS
- Source: Winkelmann, Borchen, Kreis Paderborn, Germany
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 355 g mean (304 - 391 g)
- Housing: Makrolon cages type IV, 5 animals/cage
- Diet: Altromin3022 ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): ca.50 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
propylene glycol
Concentration / amount:
induction: 5 % and 25 %
challenge: 12 %
No. of animals per dose:
10
Details on study design:
first induction intradermal,
second induction topical one week later.
Challenge three weeks later.
Positive control substance(s):
yes
Remarks:
formaldehyde

Results and discussion

Positive control results:
weak positive response, 1/10 animals at the 24 hour observation

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
12 %
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12 %. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
1
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: 1.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
12 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd 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: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.5 %
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.5 %. No with. + reactions: 8.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In this study there is no evidence that 1H-Benzotriazole is a skin sensitizer.