Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-08-22 until 2000-10-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study according to OECD 406

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): ASC plus
- Substance type: powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: 0604
- Expiration date of the lot/batch: 12/2001
- Stability under test conditions: no data
- Storage condition of test material: room temperature

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: Hasrlan Winkelmann GmbH
- Weight at study initiation: males: 339 - 431 g, females 334 - 362 g
- Housing: in groups of 5
- Diet (e.g. ad libitum): ad libitum, Harlan Teklad FD2 Guinea Pig Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 days pilot study, 9 days main study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 16 times per hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
5%, 50%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%, 50%
No. of animals per dose:
5 male, 5 female
Details on study design:
RANGE FINDING TESTS:
1 male and 1 female guinea pig, intradermal injection of 0.1 ml of a 5 % formulation in water with Freund's complete adjuvans and
1 male and 1 female guinea pig, dermal application of 0.5 g of a 50% formulation in vaseline.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h
- Test groups: one male and one female
- Control group: 3 male and 2 female animals
- Site: back
- Frequency of applications: single
- Duration: 48 h
- Concentrations: 0.5% and 5%

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: day 14 after the last induction
- Exposure period: 24 h
- Test groups: one male and one female
- Control group: 3 male and 2 female animals
- Site: back
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hs
Challenge controls:
positive control study from 2000-07-11 to 2000-08-04
Positive control substance(s):
yes

Results and discussion

Positive control results:
Expected positive reaction was demonstrated.

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5 g of a 50% formulation in vaseline.
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 g of a 50% formulation in vaseline.. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
ASC plus is not sensitising
Executive summary:

ASC plus was tested in a guinea pig maximisation test according to OECD 406 for its sensitising properties. In 2 pilot studies with one male and one female animal in each study the effects of an intradermal injection of 0.1 ml of a 5% formulation in water with Freund's complete adjuvans and the effect of a dermal application of 0.5 g of a formulation in vaseline were tested.

48 hours after the end of the application no effects were seen in comparison to the pure vehicle.

In the main study with 5 male and 5 female animals a first induction was started with the intradermal injection of 0.1 ml of a 5 % formulation in water with Freund's complete adjuvans.

The second induction was done 7 days later by an occlusive dermal application of 0.5 g of a formulation in vaseline.

14 days after the end of the 2nd induction the challenge was done by an occlusive dermal application of a 50 % formulation in vaseline for 24 hours. The effect was controlled 24 and 48 hours after the end of the application.

The animals of the treatment group recieved also applications of vehicle only at another part of the back. 3 male and 2 female guinea pigs of a control group recieved vehicle only.

With the treatment groups no effects were seen at any time point during the study.

After treatment with pure vaseline a light reddening of the skin was observed at the time point 24 hours after the end of the challenge.

The positive control was done by a seperate study in the time from 2000-07-11 to 2000 -08 -04.

According to the results of this study ASC plus is not sensitising.