Registration Dossier
Registration Dossier
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EC number: 425-450-9 | CAS number: 294-90-6
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:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test.
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.6
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Migrated from NONS file.
Test material
- Reference substance name:
- -
- EC Number:
- 425-450-9
- EC Name:
- -
- Cas Number:
- 294-90-6
- Molecular formula:
- C8H20N4
- IUPAC Name:
- 1,4,7,10-tetraazacyclododecane
- Test material form:
- not specified
- Details on test material:
- - Substance name: 1,4,7,10-tetraazacyclododecane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
Study design: in vivo (non-LLNA)
Induction
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 20% test substance in 1% aqueous carboxylmethyl cellulose
Challenge
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 5% test substance in 1% aqueous carboxylmethyl cellulose
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 5
- Challenge controls:
- Negative challengue controls
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
- Erythema (24 h) and necrosis (24 and 48 h)after injection.
- Erythema in 2 treated animals (day 10).
Maximum concentration not causing irritating effects in preliminary test: 20 %.
Signs of irritation during induction:
Evidence of sensitisation of each challenge concentration:
No evidence of sensitization.
Other observations:
None
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Migrated information criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not classified as a sensitisation agent.
- Executive summary:
A skin sensitization test was performed according to OECD guideline 406 and 92/69/EWG, B.6 Guideline under GLP conditions.
Himalayan guinea pigs were administered with test substance using CMC as a vehicle (20% test substance in 1% aqueous CMC for test subjects and 5% test substance in 1% aqueous CMC for the challenge group). Readings were performed 24 and 48h after injection.
The results provided evidence that the test substance did not cause any irritating effects hence, the test substance is not classified as a skin sensitizer agent.
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