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EC number: 236-740-8 | CAS number: 13472-08-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- pre-GLP study. GPMT performed similar to current scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test was conducted before LLNA method was adopted
Test material
- Reference substance name:
- 2,2'-azobis[2-methylbutyronitrile]
- EC Number:
- 236-740-8
- EC Name:
- 2,2'-azobis[2-methylbutyronitrile]
- Cas Number:
- 13472-08-7
- Molecular formula:
- C10H16N4
- IUPAC Name:
- 2,2'-diazene-1,2-diylbis(2-methylbutanenitrile)
- Details on test material:
- - Purity: 96%
Constituent 1
- Specific details on test material used for the study:
- Purite: 100%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: contol animals average weight - 508 g; test animals average weight - 518 g
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS: not reported
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: See Remark
- Remarks:
- Dimethyl phthalate (DMP)
- Concentration / amount:
- 8% and 80% in DMP
- Day(s)/duration:
- 4 weeks
Challenge
- Route:
- other: epicutaneous
- Vehicle:
- other: see Remark
- Remarks:
- Dimethyl phthalate (DMP)
- Concentration / amount:
- 8% and 80% in DMP
- Day(s)/duration:
- 24 and 48 hrs
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: No sensitisation was observed at 10, 21, 42, or 83% (w/v) when tested in 3 guinea pigs per concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 4 weeks
- Test groups: 1, 80% and an 8% suspension of the test material in the primary irritation test on same animal
- Control group: yes, no treatment
- Site: sacral intradermal injection
- Frequency of applications: 1 each week beginning 2 days after the test for primary irritation
- Duration: 4 weeks
- Concentrations: 0.1 ml of a 1.0% suspension in DMP,
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 days
- Exposure period: 24 hours and 48 hours
- Test groups: 1, 80% and an 8% suspension of the test material on same animal
- Control group: yes, At the same time 10 unexposed guinea pigs (controls) of the same age received identical topical applications.
- Site: shaved, intact shoulder skin.
- Concentrations: 0.05 ml of an 80% and an 8% suspension of test material in DMP
- Evaluation (hr after challenge): 24 hours and 48 hours - Challenge controls:
- At the same time 10 unexposed guinea pigs (controls) of the same age received identical topical applications (0.05 ml of an 80% and an 8% suspension of test material in DMP).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- all
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- all
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The test substance caused no irritation on shaved intact skin of 10 guinea pigs at 24 or 48 hours in both the primary irritation test and in the sensitization challenge. None of the test guinea pigs showed a sensitization response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not sensitizing
- Conclusions:
- Not sensitising
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). - Executive summary:
The primary irritation test was conducted on 10 unexposed guinea pigs by applying and lightly rubbing in 0.05 mL of an 80% and an 8% suspension of the test material in DMP on shaved, intact shoulder skin. The induction phase began 2 days after the primary irritation test and continued for 4 weeks, one injection each week. After a 13-day rest period, the test guinea pigs were challenged for sensitization by applying and lightly rubbing in 0.05 mL of an 80% and an 8% suspension of test material in DMP on shaved, intact shoulder skin. The test substance caused no irritation on shaved intact skin of 10 guinea pigs at 24 or 48 hours. None of the test guinea pigs showed a sensitization response.
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