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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
analytical purity not reported
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: about 10 weeks
- Weight at study initiation: 306- 437 g (male, female)
- Housing: individually in Macrolon cages (Type III)
- Diet: standard guinea pig pellets, ad libitum
- Water: fresh water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 12/12
- Photoperiod (hrs dark / hrs light):

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Vaseline (white petroleum)
Concentration / amount:
Induction: 1% (intradermal) + 30% (epicutaneous)
Challenge: 3%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline (white petroleum)
Concentration / amount:
Induction: 1% (intradermal) + 30% (epicutaneous)
Challenge: 3%
No. of animals per dose:
10 (controls), 20 (in test groups)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) adjuvant/saline
Injection 2: test substance in physiological saline
Injection 3: test substance in a 1:1 mixture (v/v) adjuvant/saline
- Control group:
Intradermal (1 pairs of injection):
Injection 1: aa 1:1 mixture (v/v) adjuvant/saline
- Site: shaved neck
Epicutaneous
-Site: Example: shoulder region (intradermal + epicutaneous)
- Frequency of applications: Example: every 7 days
- Duration: Example: Days 0-8
- Concentrations: Example: intradermal 1%, epicutaneous 30%
- Frequency of applications: once a week

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 24 and 48 h

Positive control substance(s):
yes
Remarks:
p-phenylenediammine / potassiumdichromate

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% (induction), 3% (challenge)
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: 1% (induction), 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% (inductionl) , 3% (challemge)
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: 1% (inductionl) , 3% (challemge). No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1% (induction) , 3% (challenge)
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: 1% (induction) , 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1% (induction), 3% (challenge)
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: 1% (induction), 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

RESULTS

The incidence of positive animals per group and the individual challenge reactions are listed in Table 1, 2 and 3.

The individual animal weights at start and end of the test are listed in Table 4.

 

Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.

 

Table 1: Number of animals per group after occlusive epicutaneous application

Group

 

After 24 hours

After 48 hours

Control group

Vehicle control

0 / 20

0 / 20

 

Test compound

0 / 10

0 / 10

Test group

Vehicle control

0 / 20

0 / 20

 

Test compound

0 / 20

0 / 20

 

 Table 2: Challenge reactions after epicutaneous administration (CONTROL GROUP)

 

DRAIZE SCORE 24 hours after removal of the dressing:

Vehicle control

Male animals

341

342

344

344

345

346

348

348

349

350

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

351

352

353

354

355

356

357

358

359

360

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Test compound control

Female animals

351

352

353

354

355

356

357

358

359

360

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

 

 

DRAIZE SCORE 48 hours after removal of the dressing:

Vehicle control

Male animals

341

342

344

344

345

346

348

348

349

350

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

351

352

353

354

355

356

357

358

359

360

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Test compound control

Female animals

351

352

353

354

355

356

357

358

359

360

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

 

 

Table 3: Challenge reactions after epicutaneous administration (TEST GROUP)

 

DRAIZE SCORE 24 hours after removal of the dressing:

Vehicle control

Male animals

321

322

323

324

325

326

327

328

329

330

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

331

332

333

334

335

336

337

338

339

340

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Test compound

Male animals

321

322

323

324

325

326

327

328

329

330

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

331

332

333

334

335

336

337

338

339

340

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

 

DRAIZE SCORE 48 hours after removal of the dressing:

Vehicle control

Male animals

321

322

323

324

325

326

327

328

329

330

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

331

332

333

334

335

336

337

338

339

340

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Test compound

Male animals

321

322

323

324

325

326

327

328

329

330

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

 

Female animals

331

332

333

334

335

336

337

338

339

340

Erythema score:

0

0

0

0

0

0

0

0

0

0

Edema score:

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified