Registration Dossier
Registration Dossier
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EC number: 230-819-0 | CAS number: 7328-91-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method: other: nach Magnusson, B. und Kligman, A.M.: J. Invest. Dermatol. 52, 268-276
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Older study available.
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diamine
- EC Number:
- 230-819-0
- EC Name:
- 2,2-dimethylpropane-1,3-diamine
- Cas Number:
- 7328-91-8
- Molecular formula:
- C5H14N2
- IUPAC Name:
- 2,2-dimethylpropane-1,3-diamine
- Test material form:
- liquid
- Details on test material:
- Neopentandiamin
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: Lippische Versuchstierzucht Hagemann GmbH &Co. KG, Extertal
- Weight at study initiation: 345 - 455 g
- Housing: 6 animlas per cage
- Diet (e.g. ad libitum): Ssniff GK 4 mm, Standarddiät für Kaninchen und Meerschweinchen
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 10%
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5%
- No. of animals per dose:
- 6
- Details on study design:
- Induction:
Day 0: intradermal injection (3 paris of injections)
1. 2 x 0.1 ml an aqueous mixture of Freud´s complete adjuvant (FCA)
2. 2 x 0.1 ml test substance preparation (10%)
3. 2 x 0.1 ml test substance preparation (10%) and FCA
Day 7: percutane application
with 10% test substance preparation
Day 19: 1. Challange: ca. 0.15 g of test substance preparation (5%) on filter-paper under a sealed dressing
Day 28. 2. Challange: ca. 0.15 g of test substance preparation (5%) on filter-paper under a sealed dressing
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance is a skin sensitiser.
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