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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 July 1996 - 12 July 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- 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
- Reference substance name:
- 2,2'-AZOBIS(ISOBUTYRONITRILE) (AZDN)
- IUPAC Name:
- 2,2'-AZOBIS(ISOBUTYRONITRILE) (AZDN)
- Reference substance name:
- 2,2'-dimethyl-2,2'-azodipropionitrile
- IUPAC Name:
- 2,2'-dimethyl-2,2'-azodipropionitrile
- Details on test material:
- - Name of test material (as cited in study report): 2,2'-AZOBIS(ISOBUTYRONITRILE) (AZDN)
- Molecular weight (if other than submission substance): 164.24
- Physical state: Solid (white powder)
- Analytical purity: 99.2 %
- Purity test date: 27.03.0995
- Lot/batch No.: 721
- Expiration date of the lot/batch: April 1997
- Storage condition of test material: In dark, at room temperature and at +4 °C from June 1996
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage cunicole de Val de Selle, 80160 Prouzel, FRANCE
- Weight at study initiation: 2.8 +/- 0.1 kg
- Age at study initiation : no data
- Housing: no data
- 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 -70 %
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye which remained untreated served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- The lower and upper eyelids were held together for about one second to avoid any loss of test substance. The eyes were not rinsed after administration of the test substance.
- Observation period (in vivo):
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance. If there was persistent ocular irritation after 72 hours, the observation period is extended to a maximum of 21 days (until day 22) in order to determine the progress of the lesions and their reversibility.
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were not rinsed after administration of the test substance.
SCORING SYSTEM: Ocular irritation was evaluated for each animal according to the grading scale of OECD test guideline 405
TOOL USED TO ASSESS SCORE: To determine the presence or absence of corneal opacification, one or two drops of 0.5 % sodium fluorescein solution was instilled into the eye before the 24-hour reading.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24-72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48-72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (1 animal)
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48-72 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- (area)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48-72 hours
- Irritant / corrosive response data:
- At the 1-hour reading, slight conjunctival reactions were observed in all animals: very slight or slight chemosis (grade 1 or 2) and very slight conjunctival redness (grade 1) were noted. These conjunctival reactions persisted up to day 2 (1 animal) and 3 (2 animals).
A very slight iritis (grade 1) was observed in one animal on day 1: it persisted for 24 hours.
At the 24-hour reading, a very slight corneal opacity (grade 1) was observed in two animals: it persisted for 24 hours in one of them.
The mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.0 and 1 for chemosis; 0.3, 0.7 and 0.7 for redness of the conjunctiva; 0.0, 0.0 and 0.3 for iris lesions and 0.3, 0.0 and 0.7 for corneal opacity.
Any other information on results incl. tables
Individual ocular examination and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal :
Rabbit number |
Region of eye |
Description of ocular reactions |
Scores |
Mean irritation score |
|||
1h D1 |
24h D2 |
48h D3 |
72h D4 |
||||
01 |
Conjunctivae
Iris
Corneal opacity |
- Chemosis - Redness
- Intensity
|
2 1
0
0
|
1 1
0
1
|
0 0
0
0
|
0 0
0
0
|
0.3 0.3
0
0.3
|
02 |
Conjunctivae
Iris
Corneal opacity |
- Chemosis - Redness
- Intensity |
1 1
0
0
|
0 1
0
0
|
0 1
0
0
|
0 0
0
0
|
0 0.7
0
0
|
03 |
Conjunctivae
Iris
Corneal opacity |
- Chemosis - Redness
- Intensity |
2 1
1
0
|
2 1
1
1
|
1 1
0
1
|
0 0
0
0
|
1 0.7
0.3
0.7
|
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information (but not classified) Criteria used for interpretation of results: other: According to EU regulation (EC) No 1272/2008 (CLP) and EU Directive 67/584/EEC
- Conclusions:
- Very slight and transient ocular reactions were observed after administration of the test item into the eye of 3 rabbits. According to the criteria laid down in Council Directive 67/548/EEC, AZDN is considered as non-irritant for the eye.
- Executive summary:
The potential of the test item 2,2'-AZOBIS(ISOBUTYRONITRILE) to induce eye irritation was evaluated in rabbits according to OECD guideline 405. The study was conducted in compliance with the principles of the Good Laboratory Practice Regulations.
Methods:
As no irritant effects were anticipated, a single dose of 100 mg of the test substance was introduced into the left conjunctival sac of three New Zealand White rabbits. The right eye served as a control. The test substance was used in its original form. The eyes were not rinsed after administration of the test substance.
The mean values of the scores recorded for each animal after 24, 48 and 72 hours were calculated.
Results:
At the 1-hour reading, slight conjunctival reactions were observed in all animals: very slight or slight chemosis (grade 1 or 2) and very slight conjunctival redness (grade 1) were noted. These conjunctival reactions persisted up to day 2 (1 animal) and 3 (2 animals).
A very slight iritis (grade 1) was observed in one animal on day 1: it persisted for 24 hours. At the 24-hour reading, a very slight corneal opacity (grade 1) was observed in two animals: it persisted for 24 hours in one of them.
The mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0 and 1 for chemosis, 0.3, 0.7 and 0.7 for redness of the conjunctivae, 0, 0 and 0.3 for iris lesions and 0.3, 0 and 0.7 for corneal opacity.
Conclusions:
According to the criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item 2,2'-AZOBIS(ISOBUTYRONITRILE) is considered as non-irritant for the eye and is not classified.
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