Registration Dossier
Registration Dossier
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EC number: 203-505-6 | CAS number: 107-58-4
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitization to patch test acrylates.
- Author:
- Kanerva, L., Estlander, T. & Jolanki R.
- Year:
- 1 988
- Bibliographic source:
- Contact Derm., 18, 10-15
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch-Test
- Principles of method if other than guideline:
- Patch-Test was conducted to determine the skin sensitisation effects of test chemical on humans.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The patch test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- N-tert-butylacrylamide
- EC Number:
- 203-505-6
- EC Name:
- N-tert-butylacrylamide
- Cas Number:
- 107-58-4
- Molecular formula:
- C7H13NO
- IUPAC Name:
- N-tert-butylacrylamide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: N-tert-Butylacrylamide
- Molecular formula: C7-H13-N-O
- Molecular weight: 127.1857g/mol
- Smiles notation: CC(C)(C)NC(=O)C=C
- InChl: 1S/C7H13NO/c1-5-6(9)8-7(2,3)4/h5H,1H2,2-4H3,(H,8,9)
- Substance type: organic
- Physical state: solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Source: Department of Dermatology, Institute of Occupational Health, Finland
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 5 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Day(s)/duration:
- 5 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 22
- Details on study design:
- - No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 22 patients
- Control group: not specified
- Site: on the back
- Frequency of applications: 1
- Duration: 5 days
- Concentrations: 1%
- Evaluation: the test site was read on patch removal and after 24, 48, 72 and 96-120 hours.
OTHER: the test chemical was applied on the back with a non-occlusive porous tape (Scanpor Surgical Tape) or when the back is full of patch test, thighs were used. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 22
- Clinical observations:
- one patient showed slight to moderate irritation from this compound
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Conclusions:
- None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.
- Executive summary:
The sensitization potential of test chemical was assessed in 22 patients by patch testing. The patients were treated with 1% of test chemical in petrolatum for 24 hours under occlusive condition.
The test chemical was applied on the back with a non-occlusive porous tape (Scanpor Surgical Tape) or when the back is full of patch test, thighs were used. The test site was read on patch removal and after 24, 48, 72 and 96-120 hours.
None of the patients experienced sensitization to test chemical although one patient showed slight to moderate irritation from this compound. Hence the test chemical can be considered as not sensitizing to the skin.
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