Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-08-31 to 1981-10-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to OECD guideline 406, no GLP study, unclear if highest non irritating dose was used. Only 20 % mixture in peanut oil was tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchtstierzucht, Hagemann GmbH & Co. KG, Hamelner Straße 3, 4923 Exertal
- Weight at study initiation: 250 g (mean weight)
- Housing: Macrolon cages III, height: 14 cm, width: 25 cm, length: 42 cm
- Diet: Ssniff-G, pellets
- Water: ad libitum, tap water
- Acclimation period: ca 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12, light from 7 am to 7 pm

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
peanut oil
Concentration / amount:
0.5 mL
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
peanut oil
Concentration / amount:
0.5 mL
No. of animals per dose:
20 females test group
10 females control group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test group: 20 test animals were treated once a week for the duration time of 3 weeks on the clipped left side with the test substance.
- Control group: 10 animals were treated only with the vehicle in a similar manner to that used for the treated group.
- Site: Clipped left side
- Frequency of applications: every week
- Duration: 3 weeks
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.

B. CHALLENGE EXPOSURE (14 days after the last induction exposure)
- No. of exposures: 3
- Exposure period: 6 hours
- Test group/ Control group: Both groups are treated with the test substance on the right side of the animals.
- Site: Right side
- Concentrations: 0.5 mL in a 20 % mixture in peanut oil.
- Evaluation (hr after challenge): Right side was depilated after 24 hours, evaluation after 2 hours, 24 and 48 hours
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 mL
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: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5 mL
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: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 mL
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: 0.5 mL. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 mL
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: 0.5 mL. 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: EU
Conclusions:
The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. No sensitizing potential was found under the test conditions.
Executive summary:

The skin sensitizing potential of the test item was tested in the Buehler Test, using 20 % of the test substance in peanut oil. A sensitization study was conducted using white Pirbright guinea pigs weighing approx. 250 gm at the start of the study. Animals were housed 2/cage in macrolon plastic cages. Bedding was from pure spuce-, fir- or pine-wood, dried and disdusted. Fluorescent lighting was on 12 hr daily, temperature was 21 C, and relative humidity, 45 to 55%. Food and water was provided ad libitum. After an acclimatization period of 7 days, animals were divided into two groups of 20 female animals (test group) and 10 female animals (control group). Prior to treatment, the left shoulder of each animal was clipped with a small animal clipper (about 8 x 5 cm). 0.5 mL of the test substance was applied undiluted to a 2 x 2 cm gauze pad. The patches were placed on the clipped left shoulder of each animal of the test group and secured with a wrapping of Elastoplast. Then the animals were immobilized in restrainers for 6 hours. After that time the patches were taken off. The procedure was repeated at the same side once weekly during the next two weeks for a total of three 6 hr exposures. After the last induction exposure, the animals were left untreated for 2 weeks before primary challenge. The animals previously exposed during the induction period as well as the previously untreated control animals were treated following the same patching procedure as for induction but the patches were applied to the freshly clipped right side that has not been treated before. 24 hours after the primary challenge all animals were depilated on the right side. The test sites were graded 6, 24 and 48 hours after the depilation by comparing the treated test animals with the animals of the control group. Any signs of erythema and other lesions were recorded. No skin sensitizing potential was observed during the study.