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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:
1995
Report Date:
1995

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)
Qualifier:
according to
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
study was conducted before implementation of LLNA

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material: Etingal
- Physical state: liquid, achromatic
- Lot/batch No.: MG-94-37
- Storage condition of test material: room temperature
- Substance number: 94/261

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White, Dunkin Hartley Crl: (HA)BR (SPF)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH - Wiga, Sulzfeld, FRG
- Age at study initiation: Young adult animals
- Weight at study initiation: 313 - 388 g
- Housing: No. of animals per cage: 5. Type of cage: Makrolon, type IV. Bedding: Granulat Typ 3/4 (staubfrei); SSNIFF
- Diet (ad libitum): Kliba Labordiät 341 (Kaninchen- Meerschweinchen-Haltungsdiät)
- Water (ad libitum): tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: 8 days before the beginning of the study in the laboratory for dermal toxicity

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70% .
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h light (6.00 a.m. - 6.00 p.m.) 12 h darkness (6.00 p.m. - 6.00 a.m.)

IN-LIFE DATES:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: olive oil
Concentration / amount:
75 % / 0.5 mL
Day(s)/duration:
3 times (once per week) for 6 hours, respectively
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: olive oil
Concentration / amount:
50 % / 0.5 mL
Day(s)/duration:
6 hours
No. of animals per dose:
Pretest: 4
Main test;
- control group: 10
- test group: 20
Details on study design:
2 x 2 cm gauze patches were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm
from Russka, test patch of Idealbinde 5 x 5 cm from Pfälzische Verbandstoff-Fabrik, and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). 0.5 mL of the test substance or test substance preparations were exposed to the animals.

RANGE FINDING TESTS:
Duration of exposure: 6 hours
Site of application: right and left flank
Application frequency: 2 times (one application per week) on the same application area
Number of test animals: 4 per test concentration
Readings: 24 and 48 h after the removal of the patch
Assessment of skin findings: according to Draize, J.H. (1959)

MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: anterior left flank
- Frequency of applications: 3 times (one application per week; days 0, 7 and 14) on the same application area
- Concentrations: 75%

B. CHALLENGE EXPOSURE
- Day(s) of challenge: 14 days after the third induction
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: Substance formulation: anterior right flank. Vehicle: posterior right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch
Challenge controls:
Treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 10 was applied as a vehicle. Control group 2 only received olive oil DAB 10.
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde

Results and discussion

Positive control results:
The positive control showed that the test system was able to detect sensitizing compounds under laboratory conditions chosen.

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 ml
No. with + reactions:
9
Total no. in group:
18
Clinical observations:
very slight erythema

Applicant's summary and conclusion