Registration Dossier
Registration Dossier
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EC number: 425-450-9 | CAS number: 294-90-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.4.
- GLP compliance:
- yes
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 vitro test system
- Control samples:
- yes, concurrent vehicle
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Distilled Water
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- ( mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Max. duration: 21; Max. value at end of observation period: 4 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: Max duration: 21d; Max. value at end of observation period: 2 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days.
- Other effects:
- One animal died on day 19, but there was no indication of substance relationship.
Applicant's summary and conclusion
- Interpretation of results:
- other: Corrosive
- Remarks:
- Migrated information criteria used for interpretation of results: EU
- Conclusions:
- Test substance, after 72h, was classified as corrosive with not fully reversibility of observed effects.
- Executive summary:
A skin irritation/corrosion test was performed according to OECD guideline 404, and 92/69/EWG, B.4 under GLP conditions.
500mg of test substance were administered to three New Zealand White rabbits in semiocclusive conditions using distilled water as a vehicle. Test substance effects were not fully reversible within 21 days.
Regarding the available data, test substance was classified as corrosive.
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