Registration Dossier
Registration Dossier
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EC number: 606-883-4 | CAS number: 219921-94-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- EC Number:
- 606-883-4
- Cas Number:
- 219921-94-5
- Molecular formula:
- C16-H26-N2 x C7-H11-N-O5
- IUPAC Name:
- (S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): AGEE 623 Glutaminate; L-Glutamic acid, N-acetyl-, compd. with (S)-alpha-(2-methylpropyl)-2-(1-piperidinyl-)benzenemethanamine
- Physical state: white solid
- Analytical purity: measured peak over area: 100% (4% of (R)-(-)-enantiomer); HPLC
- Lot/batch No.: T29725
- Expiration date of the lot/batch: 31 december 1999
- Storage condition of test material: room temperature, light protected in the closed container
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: approx. 4-5 week
- Weight at study initiation: 301-312 g
- Housing: barrier maintained (semi-barrier) in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum, Altromin 3122 diet
- Water (e.g. ad libitum): ad libitum, tap water
- Sex: female
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): at least 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 : 12 hours, light 6.30 - 18.30
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- For the topical applications (induction- second stage and challenge) the test item was applied at a 100% concentration.
For the intradermal injection first stage a 20% concentration was chosen.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- For the topical applications (induction- second stage and challenge) the test item was applied at a 100% concentration.
For the intradermal injection first stage a 20% concentration was chosen.
- No. of animals per dose:
- 10 test animals; 5 control animals per test
- Details on study design:
- RANGE FINDING TESTS: For the justification of dose levels a preliminary test was performed. Three animals were topically treated with the test item. No signs of irritation were recorded after a contact period of 24h. Therefore the maximum concentration was chosen for the topical induction and the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections per animal for intra-dermal induction test, 1 patch per animal for dermal induction test.
- Exposure period: 48h (epicutaneous)
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: day 20 after first induction test
- Exposure period: 24 hours
- Test groups: 1 group, 10 animals per group
- Control group: 1 group, 5 animals per group
- Evaluation (hr after challenge): 24h, 48h and 72h after exposure - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
Any other information on results incl. tables
Frequency of Sensitization in Comparison to Control Animals
| E0 | E1 | E2 | E3 | E4 | O0 | O1 | O2 | O3 | O4 | % | |
| T24 | 10 | -- | -- | -- | -- | 10 | -- | -- | -- | -- | 0 |
| T48 | 10 | -- | -- | -- | -- | 10 | -- | -- | -- | -- | 0 |
| T72 | 10 | -- | -- | -- | -- | 10 | -- | -- | -- | -- | 0 |
| C24 | 5 | -- | -- | -- | -- | 5 | -- | -- | -- | -- | |
| C48 | 5 | -- | -- | -- | -- | 5 | -- | -- | -- | -- | |
| C72 | 5 | -- | -- | -- | -- | 5 | -- | -- | -- | -- |
E=Erythema; O=Oedema; 0 -4=Grade (Classification System Magnusson and Kligman); T=Test group; C=control group
24, 48, 72 hours after end of challenge treatment
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The sensitization rate after application of AGEE 623 Glutaminate was 0%. Under the test conditions described below the test item showed no sensitizing properties. No other signs of toxicity were observed. All animals showed normal food intake and weight gain.
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