Registration Dossier
Registration Dossier
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EC number: 604-603-5 | CAS number: 147769-93-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.11.98 - 15.01.99
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with an OECD guideline
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:
- AGEE 623 Amine
- IUPAC Name:
- AGEE 623 Amine
- Reference substance name:
- 108157-52-4
- Cas Number:
- 108157-52-4
- IUPAC Name:
- 108157-52-4
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): AGEE 623 Amine
- Physical state: dark, liquid
- Analytical purity: 80.6 %
- Composition of test material, percentage of components: batch contains 20% solvent
- Lot/batch No.: T29844
- Expiration date of the lot/batch: December 31, 1999
- Stability under test conditions: stable for at least 2 hours in water and organic solvents
- Storage condition of test material: 4 °C, light protected in the closed container
- Other:
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH
- 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 weeks
- Weight at study initiation: 300-316 g
- Housing: groups of max. 10 in Terluran- cages
- Diet (e.g. ad libitum): Feeding ad libitum, Altromin 3122 maintenance diet for guinea pigs, rich in crude fiber, totally-pathogen-free-TPF.
- Water (e.g. ad libitum): Free access to tap water ( drinking water, municipal residue control, microbiol. controlled periodically).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3° C
- Humidity (%): 55± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12: 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- For the intradermal injection and topical application (induction- first and second
stage) the test item was applied at a 50% concentration. For challenge
application a 10% concentration was chosen ( diluted with Cottonseed Oil).
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- For the intradermal injection and topical application (induction- first and second
stage) the test item was applied at a 50% concentration. For challenge
application a 10% concentration was chosen ( diluted with Cottonseed Oil).
- No. of animals per dose:
- test: 10 females
control: 5 females - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Results
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
The results for the experimental animals at the challenge phase (10% concentration of the test item) were compared with the results for the control animals. None of the 10 animals of the test group showed allergic skin reactions until 72 hours after patch removal as compared to the intraspecific application of Cottonseed Oil and to the animals of the control group. The maximum percentage of animals sensitized was 0 %. Animals of both groups survived throughout the test period. Animals of the test group showed reduced weight gain as compared to historical data and the animals ofthe control group
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this sensitization test it can be stated that
the test item AGEE 623 Amine caused no reactions identified as sensitization.
According to EEC criteria for classification (93/21/EEC) no labelling is necessary
as the sensitization rate was below 30%.
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