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EC number: 204-650-8 | CAS number: 123-77-3
- 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:
- 22 April - 06 May 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with official test guidelines (US Rederal Register) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- C,C'-azodi(formamide)
- EC Number:
- 204-650-8
- EC Name:
- C,C'-azodi(formamide)
- Cas Number:
- 123-77-3
- Molecular formula:
- C2H4N4O2
- IUPAC Name:
- diazene-1,2-dicarboxamide
- Details on test material:
- - Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: 100%
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: ambient temperature in the dark
- Other:
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, ENGLAND
- Age at study initiation: 8 to 15 weeks
- Weight at study initiation: 1.9 to 3.3 kg
- Housing:individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: acclimation reported but time period not specified.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 48 mg (the weight occupying a volume of 0.1ml) placed in the lower everted lid of one eye of each animal. - Duration of treatment / exposure:
- The eyelids were gently held together for one second before releasing.
- Observation period (in vivo):
- 1 hour, and 1, 2, 3, 4, and 7 days after instillation.
Observation of the eyes was aided by the use of a handheld torch. - Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacreous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris) Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2*
Diffuse, beefy red 3*
Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half-closed 3*
Swelling with lids more than half-closed 4*
*Interpreted as a positive effect
TOOL USED TO ASSESS SCORE: hand torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 1h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 1h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 48h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals gave a "positive" response. No corneal damage or iridial inflammation were observed. Mild conjunctival irritation was observed in four of the animals, in one animal at the one hour reading only. The reactions in the other three animals had resolved two days after instillation of the test substance. The remaining two animals showed no response to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of Unifoam AZ SO-NL into the rabbit eye did not elicit a positve response in any of the six treated animals according to T.S.C.A. test criteria.
- Executive summary:
An eye irritation test was performed to determine the potential of the test substance Unifoam AZ SO-NL to cause irritation in the eye (HLS 1988, OCI67/88638D). The study was conducted in accordance with US EPA test guidelines, and in compliance with GLP.
48 mg (the weight equialent to 0.1 mL) of the test substance was instilled into one eye of each of six New Zealand White rabbits. The untreated eye in each rabbit was used as a reference by which to compare the treated eye. Examinations of the eyes were made 1 hour and 1, 2, 3, 4, and 7 days after instillation. Observation of the eyes was aided by the use of a handheld torch.
None of the animals gave a "positive" response. No corneal damage or iridial inflammation were observed. Mild conjunctival irritation was observed in four of the animals, in one animal at the one hour reading only. The reactions in the other three animals had resolved two days after instillation of the test substance. The remaining two animals showed no response to treatment.
Instillation of Unifoam AZ SO-NL into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria.
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