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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 July 1996 - 6 July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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)
- molecular weight: 164.24
- Physical state: solid (white powder)
- Analytical purity: 99.2%
- Purity test date: 27.03.1995
- Lot/batch No.: 721
- Expiration date of the lot/batch: 04.1997
- Storage condition of test material: in dark at <15°C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage cunicole de Val de Selle, 80160 Prouzel, FRANCE.
- Weight at study initiation: 2.7 +/- 0.1 kg
- Housing: Individually in polystyrene cages (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm)
- 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): 18 +/- 3 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12h / 12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin was examined 1 hour, 24, 48 and 72 hours after removal of the dressing. If there were persistent cutaneous reactions after 72 hours, the observation was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility.
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
Any residual was wiped off by means of a dry gauze pad.
SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to the grading scale as per OECD test guideline 404 (see below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No cutaneous reactions were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- According to EU regulation (EC) No 1272/2008 (CLP)
- Conclusions:
- No cutaneous reactions were observed after a 4-hour exposure period onto the skin of 3 rabbits. 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 considered as non-irritant to the skin.
- Executive summary:
The potential of the test item 2,2'-AZOBIS(ISOBUTYRONITRILE) to induce skin irritation was evaluated in rabbits according to OECD guideline 404. The study was conducted in compliance with the principles of the Good Laboratory Practice Regulations.
Methods:
The test item was applied for 4 hours to 3 New Zealand White rabbits. A single dose of 500 mg of the test substance was applied to the closely-clipped skin of the flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.
Results:
No cutaneous reactions were observed during the study.
Conclusion:
The test item 2,2' AZOBIS(ISOBUTYRONITRILE) is considered as non-irritant to the skin and is not classified.
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