Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-132-3 | CAS number: 78-67-1
- 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:
- key study
- Study period:
- 12 July 1996 - 05 August 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD 406)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study performed before the implementation of the REACH regulation.
Test material
- Reference substance name:
- 2,2'-dimethyl-2,2'-azodipropiononitrile
- EC Number:
- 201-132-3
- EC Name:
- 2,2'-dimethyl-2,2'-azodipropiononitrile
- Cas Number:
- 78-67-1
- Molecular formula:
- C8H12N4
- IUPAC Name:
- 2,2'-dimethyl-2,2'-azodipropiononitrile
- Details on test material:
- - Name of test material (as cited in study report): 2,2'-AZOBIS(ISOBUTYRONITRILE)
- Physical state: white powder
- Analytical purity: 99.2%
- Purity test date: 03/27/95
- Lot/batch No.: 721
- Expiration date of the lot/batch: 04/1997
- Storage condition of test material: in dark and at temperature of +4°C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d'Elevage Lebeau, 78950 Gambais, France.
- age at study initiation: 3 months
- Weight at study initiation: 324 +/- 23 g for males and 342 +/- 20 g for females
- Housing: individually in suspended wire-mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Administration by intradermal route: The concentration chosen was 0.1% (w/w).
- Application by cutaneous route: The concentration chosen for the topical application of the induction phase and for the challenge application was
100%.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- - Administration by intradermal route: The concentration chosen was 0.1% (w/w).
- Application by cutaneous route: The concentration chosen for the topical application of the induction phase and for the challenge application was
100%.
- No. of animals per dose:
- - Control group: 5 males and 5 females.
- Treated group: 10 males and 10 females.
- Details on study design:
- RANGE FINDING TESTS:
A preliminary test was conducted in order to determine the concentrations to be tested in the main study:
- By intradermal route, the maximal concentration which could pass through a needle was 0.1% (w/w). This concentration was well-tolerated and
induced 24, 48 hours and 6 days after the injection only a slight irritation.
- By cutaneous route, the undiluted test substance was applied for 24 hours under occlusive dressing to both flanks of one male and one female rabbit. No cutaneous reactions were observed 24 and 48 hours after removal of the dressing indicating that the concentration of 100% was
well-tolerated.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections:
On Day 1, the treated group received three pairs of intradermal injections of 0.1 ml in the shoulder region which was cleared of hair so that one of each pair lies on each side of the midline.
Injection 1 was a 50:50 mixture (v/v) FCA/ physiological saline
Injection 2 was the test substance at 0.1% (w/w) in paraffin oil
Injection 3 was a 50:50 mixture (w/v) of 1 and 2
On Day 1, the control group received three pairs of intradermal injections of 0.1 ml in the same sites as in the treated animals.
Injection 1 was a 50:50 mixture (v/v) FCA/ physiological saline
Injection 2 was paraffin oil
Injection 3 was a 50:50 mixture (w/v) of 1 and 2
Cutaneous Applications:
On Day 7, the test areas of the treated and control groups were clipped. As the substance was not a skin irritant, the animals were treated with 0.5 ml of 10% sodium lauryl sulfate in vaseline, in order to create a local irritation.
On Day 8, the treated group received 500 mg of the undiluted test substance which was held in contact with the test area by an occlusive dressing for 48 hours.
On day 8, the control group received 0.5 ml of paraffin oil in a similar manner.
B. CHALLENGE EXPOSURE
On day 22, the animals from both groups received an application of 500 mg of the test substance undiluted to the posterior right flank and 0.5 ml of the vehicle to the posterior left flank. The patches were held in contact by an occlusive dressing for 24 hours.
24 hours after removing the patch, the skin reaction was observed and recorded according to the Magnusson and Kligman grading scale (see below). Approximately 24 hours after this observation a second observation (72 hours) was made and once again recorded. - Challenge controls:
- no data
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro chlorobenzene.
Results and discussion
- Positive control results:
- 2,4-dinitro chlorobenzene at a concentration of 1% (w/w) induced positive skin sensitization reactions in 75% of the guinea pigs (ie 15 animals out of 20).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1% + 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1% + 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% + 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1% + 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.1% + 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.1% + 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1% + 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.1% + 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No cutaneous reactions were observed. According to the criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of laws, regulations and administrative provisions relative to the classification, packaging and labelling of dangerous substances, the test item is not considered as a skin sensitizer .
- Executive summary:
The potential of the test item 2,2'-AZOBIS(ISOBUTYRONITRILE) to induce skin sensitization was evaluated in guinea-pigs according to the maximization method of Magnusson and Kligman described in OECD guideline 406. The study was conducted in compliance with the principles of the Good Laboratory Practice Regulations.
Methods:
30 guinea-pigs were allocated to two groups: a control group1 (5 males and 5 females) and a treated group 2 (10 males and 10 females). On day 1, intradermal injections of Freund's complete adjuvant mixed with the test substance (treated group) or the vehicle (control group) were performed in the dorsal region between the shoulders. On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline (10% w/w) in order to induce local irritation. On day 8, this same test site was treated by topical application of the test substance (treated group) or the vehicle (control group) and was covered by an occlusive dressing for 48 hours. On day 22, after a rest period of 12 days, all animals of the treated and control groups were challenged by a topical application of the test substance to the right flank . The left flank served as a control and received the vehicle only. Test substance and vehicle were maintained under an occlusive dressing for 24 hours. Skin reactions were evaluated approximately 24 and 48 hours later.
The test substance concentrations for induction were 0.1% (w/w) in paraffin oil and 100% for intradermal injections and topical application respectively. For the challenge application ,the test substance was undiluted for all groups.
The sensitivity of the guinea-pigs in the experimental conditions were checked in a study with positive sensitizer : 2,4 -dinitro chlorobenzene. During induction period, the positive sensitizer was applied at 0.1% (day 1) and 1% (day 8) concentrations. At cutaneous challenge application, 1%(w/w) was tested on the right flank.
Results:
No clinical signs and no treatment-related deaths were noted during the study. No cutaneous reactions were observed after the challenge application. The guinea-pigs used in a control study, showed a satisfactory sensitization response in 75% animals using the positive sensitizer.
Conclusion:
According to the maximisation method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance 2,2'-AZOBIS(ISOBUTYRONITRILE) were observed in guinea-pigs.
According to the criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item 2,2'-AZOBIS(ISOBUTYRONITRILE) is not classified as a sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.