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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
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
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
5%, 50%
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
Positive control results:
Expected positive reaction was demonstrated.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
ASC plus was tested in a guinea pig maximisation test according to OECD 406 for its sensitising properties. According to the results of this study ASC plus is not sensitising.

Justification for selection of skin sensitisation endpoint:
reliable Guideline study under GLP, key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No positive responses were noted in any of the Test or Control Group animals of the skin sensitisation test according to OECD 406.

According to the criteria of Regulation (EC) No.: 1272/2008, the substance is not classified as skin or respiratory sensitizer. Also, according to the criteria specified by Directive 67/548/EEC the substance is not classified with regard to sensitisation.