Registration Dossier
Registration Dossier
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EC number: 219-440-1 | CAS number: 2437-25-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- 2,2'Azobis(2-Methylpropionitrile) - SIDS Initial Assessment Report
- Author:
- OECD SIDS -United Nations Environmental Programme (UNEP)
- Year:
- 1 999
- Bibliographic source:
- 2,2'Azobis(2-Methylpropionitrile) - SIDS Initial Assessment Report; OECD SIDS; SIDS Initial Assessment Report For 9th SIAM (France, June 29-July 1, 1999)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 406 and EC Guideline 92/69/E.E.C., B6.
- Principles of method if other than guideline:
- The Guinea pig maximisation test was conducted on Dunkin-Hartley guinea pigs for chemical 2,2'-Azobis(isobutyronitrile) (CAS No: 78-67-1) to assess its skin sensitization potential in accordance with OECD Guideline No. 406 and EC Guideline 92/69/E.E.C., B6.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2,2'-Azobis(isobutyronitrile)
- Cas Number:
- 78-67-1
- Molecular formula:
- C8H12N4
- IUPAC Name:
- 2,2'-Azobis(isobutyronitrile)
- Test material form:
- solid
- Details on test material:
- - Name of test material: 2,2’-Azobis(2-methylpropionitrile)
- Molecular formula: C8H12N4
- Molecular weight: 164.2108 g/mol
- Substance type: Organic
- Physical state: solid
-Smiles: CC(C)(N=NC(C)(C)C#N)C#N
-InChI: 1S/C8H12N4/c1-7(2,5-9)11-12-8(3,4)6-10/h1-4H3/b12-11+
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 2,2’-Azobis(2-methylpropionitrile)
- Molecular formula: C8H12N4
- Molecular weight: 164.2108 g/mol
- Substance type: Organic
- Physical state: solid
-Smiles: CC(C)(N=NC(C)(C)C#N)C#N
-InChI: 1S/C8H12N4/c1-7(2,5-9)11-12-8(3,4)6-10/h1-4H3/b12-11+
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 % in paraffin oil or the vehicle
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Unchanged or paraffin oil (vehicle)
- Concentration / amount:
- 100% (500 mg) or the vehicle
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Unchanged or paraffin oil (vehicle)
- Concentration / amount:
- 100% (500 mg) and the vehicle
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- No data available
- Details on study design:
- MAIN STUDY
A. I.INDUCTION EXPOSURE: INTRADERMAL
- No. of exposures: 1
- Exposure period: 7 days
- Test groups: no data
- Control group: no data
- Site: in the dorsal region between the shoulders
- Frequency of applications: no data
- Duration: 7 days
- Concentrations: 0.1 % in paraffin oil or the vehicle
A. INDUCTION EXPOSURE: dermal
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: no data
- Control group: no data
- Site: same site
- Frequency of applications: no data
- Duration: 48 hours
- Concentrations: 100% (500 mg) or the vehicle
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 12 days
- Exposure period: 24 hours
- Test groups: no data
- Control group: no data
- Site: the right and the left flank
- Concentrations: 100% (500 mg) and the vehicle
- Evaluation (hr after challenge): approximately 24 and 48 hours after challenge application
OTHER: the application was held for 24 hours with an occlusive, hypoallergenic dressing during topical application. - Challenge controls:
- No data available
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (500 mg) and the vehicle
- No. with + reactions:
- 0
- Clinical observations:
- No known skin sensitizing effects were observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test material 2,2'-Azobis(isobutyronitrile) (CAS No: 78-67-1) was considered to be not sensitizing to the skin of Dunkin-Hartley guinea pigs in a maximization test performed in accordance with OECD Guideline No. 406 and EC Guideline 92/69/E.E.C., B6.
- Executive summary:
The Guinea pig maximisation test was conducted on Dunkin-Hartley guinea pigs for chemical 2,2'-Azobis(isobutyronitrile) (CAS No: 78-67-1) to assess its skin sensitization potential in accordance with OECD Guideline No. 406 and EC Guideline 92/69/E.E.C., B6.
In the induction, each guinea pigs received 0.1 % in paraffin oil or the vehicle was injected intradermaly in the dorsal region between the shoulders on day 1. On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline in order to induce local irritation. On day 8, topical application of undiluted substance (500 mg) or the vehicle to this same site was performed with an occlusive dressing for 48 hours.
Animals were challenged after rest period of 12 days, by a topical application of undiluted substance (500 mg) and the vehicle to the right and the left flank, respectively. This application was held for 24 hours with an occlusive, hypoallergenic dressing. Skin reaction was evaluated approximately 24 and 48 hours after challenge application.
Since none of the treated guinea pigs showed any sign of skin sensitization reaction, the chemical2,2'-Azobis(isobutyronitrile) (CAS No: 78-67-1) was considered to be not sensitizing to the skin of Dunkin-Hartley guinea pigs.
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