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EC number: 605-301-6 | CAS number: 162691-59-0
Toxicological information
Skin sensitisation
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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Asta-C15-Acetal (C15-Acl)
- IUPAC Name:
- Asta-C15-Acetal (C15-Acl)
- Reference substance name:
- 94/29
- IUPAC Name:
- 94/29
- 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
Constituent 1
Constituent 2
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 chemical
- 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 chemical
- 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.
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