Registration Dossier
Registration Dossier
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EC number: 241-158-2 | CAS number: 17091-31-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01/2008 to 04/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test report was already available.
Test material
- Reference substance name:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- EC Number:
- 241-158-2
- EC Name:
- Bromo(hexahydro-2H-azepin-2-onato-N)magnesium
- Cas Number:
- 17091-31-5
- Molecular formula:
- C6H10BrMgNO
- IUPAC Name:
- magnesium(2+) ion 2-oxoazepan-1-ide bromide
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- azepan-2-one
- Test material form:
- solid: particulate/powder
Constituent 1
additive 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
FORM AS APPLIED IN THE TEST (if different from that of starting material): powder
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L' Arbresle)
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 4 weeks
- Weight at study initiation: 240 to 258 g
- Housing: groups of 2 or 3 animals, in polycarbonate containers
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22
- Humidity (%): 36 to 58
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 8.75%
- Day(s)/duration:
- 20
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 20% and 40%
- Day(s)/duration:
- 1
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 treated animals
5 control animals - Details on study design:
- RANGE FINDING TESTS:
Determination by intradermal injection of the Maximal Non Necrotizing Concentration (MNNC)
Determination by topical application of the Pre-Maximal Non Irritant Concentration (PreMNIC)
Determination by topical application of the Maximal Non Irritant Concentration (MNIC)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3x2
- Test groups: 1 (10 animals)
- Control group: 1 (5 animals
- Site: scapular zone
B. CHALLENGE EXPOSURE
- No. of exposures: 1x2
- Day(s) of challenge: 1
- Exposure period: 1
- Test groups: 1 (15 animals)
- Control group: 0
- Site: dorso-lumbar zone
- Evaluation (hr after challenge): 24 and 48 - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No cutaneous intolerance reaction
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No macroscopic cutaneous reactions attributable to allergy
Any other information on results incl. tables
No macroscopic cutaneous reactions attributable to allergy were recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item.
No cutaneous intolerance reaction was recorded in animals from the negative control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of the results, under these experimental conditions, the test item Bromo(hexahydro-2Hazepin-2-onato-N)magnesium needs not to be classified, in accordance with the criteria for classification of regulation (EC) No. 1272/2008 needs not to be classified.
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