Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD 406 and EEC Directive 92/69, B.6. Study cinducted under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
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:
- Housing: together in Makrolon, type IV cages
- Diet (e.g. ad libitum): Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet) ad libitum
- Water (e.g. ad libitum): 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: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and percutaneous
Vehicle:
other: olive oil DAB 10
Concentration / amount:
- intradermal induction: 5%
- percutaneous induction: unchanged test substance
- challenge: unchanged test substance
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: olive oil DAB 10
Concentration / amount:
- intradermal induction: 5%
- percutaneous induction: unchanged test substance
- challenge: unchanged test substance
No. of animals per dose:
10 (control) or 20 (test).
Details on study design:
Induction
Intradermal induction:
- 6 intradermal injections in groups of two per animal

Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant withaut test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 : 1
B) middle row: 2 injections each of 0.1 ml of the test substance formulation
C) back row: 2 injections each of 0.1 ml Freund's adjuvant 1 0.9% aqueous NaCl-solution (1 : 1) with test substance

Injections for control groups 1 and 2:
- The animais were given the same injections (A, B, C) but without test substance, only with the formulating agent.

Site of application:
- shoulder

Readings:
- 24 h after the beginning of application

Assessment of the skin findings:
- analogous to the pretest

Percutaneous induction:
- Percutaneous induction was carried out one week after intradermal induction

Amount applied:
2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linenpatches 6 x 4 cm from Russka and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG). The filter paper strip was soaked in the test substance. Thus, the animais were exposed to about 0.3 g of the test substance.

- The control groups were not treated, since the test substance was applied unchanged and thus no solvent was used.

Duration of exposure:
- 48 hours

Site of application:
- shoulder, same area as in the case of the previous intradermal application

Readings:
- 48 h after the beginning of application

Assessment of skin findings:
- analogous to the pretest

Challenge
Test concentration: non-irritant concentration

Challenge 21 days after intradermal induction

Amount applied:
2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm from Russka, test patch 5 x 5 cm of Idealbinde from pfälzische Verbandstoff-Fabrik, and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG9 . The test filter paper strip was soaked in the test substance; thus the Animais were exposed to about 0.15 g of the test substance.

Challenge:
- treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated)

Duration of exposure:
- 24 hours

Site of application:
- intact flank

Readings:
- 24 and 48 h after the removal of the patch

Assessment of skin findings:
- analogous to the pretest
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
unchanged test substance
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: unchanged test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
unchanged test substance
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: unchanged test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
unchanged test substance
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: unchanged test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
unchanged test substance
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: unchanged test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of the study under the test conditions chosen, it was concluded that Asta-C15-Acetal (C15-Acl) does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test. Thus, no classification is warranted according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.