Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 May - 02 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPOC:DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 400-470 g (males); 364-478 g (females)
- Housing: individually in Makrolon cages type IV
- Diet: ssniff® Ms-Z (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: time switched drinking water system (twice weekly ascorbic acid was added)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
according to guideline

IN-LIFE DATES: From: 04 May 1999 To: 02 June 1999

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin oil (control)
Concentration / amount:
Induction: 100%
Challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin oil (control)
Concentration / amount:
Induction: 100%
Challenge: 100%
No. of animals per dose:
Test substance group: 20 (10 males and 10 females)
Control group: 10 (5 males and 5 females)
Details on study design:
RANGE FINDING TESTS: In a preliminary test no primary irritation of the test substance was observed.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.5 mL test substance
- Control group: 0.5 mL paraffin oil
- Site: left flank
- Frequency of applications: every 7 days
- Duration: days 1-15
- Concentration: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (only challenge, no rechallenge was conducted)
- Day(s) of challenge: 29
- Exposure period: 6 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: posterior right flank (test substance) and anterior right flank (vehicle)
- Concentration: 100%
- Evaluation: 24 h and 48 h after start of application

Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole (last examination: Oct/Nov 1998)

Results and discussion

Positive control results:
The positive control substance mercaptobenzothiazole induced positive reactions in 4/10 animals (40%) at the substance treated site, thus meeting the reliability criteria for the Buehler test (≥15% positive response).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

In one female of the test substance group the left flank, which was treated with the vehicle paraffin oil, had a discrete or patchy erythema at only the 24 h observation time point. In the other animals the vehicle treated sites were without any findings.

No systemic toxic effects were observed. The general condition and body weight gain of the animals were not affected.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test item has no sensitising properties in the Buehler test on the skin of guinea pigs.