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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 August 2014 to 08 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): adca
- Molecular formula (if other than submission substance): C2H4N4O2
- Molecular weight (if other than submission substance): 116.08
- Physical state: Yellow powder
- Analytical purity: min 99%
- Lot/batch No.: 3L48J
- Expiration date of the lot/batch: 31 December 2014
- Storage condition of test material: Room temperature in the dark
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Reputable commercial supplier
- Age at study initiation: ca 11 weeks
- Weight at study initiation:
- Housing: Animals were group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilised sawdust as bedding material. Paper and shelters were supplied as cage-enrichment.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40-70%
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): a 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: 13 August 2014 To: 08 September 2014
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 0 (control), 10, 25 and 50% w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:The vehicle was selected on the basis of maximizing the solubility using the test substance data provided by the sponsor and trial formulation results performed at WIL Research Europe
- Irritation: Measured but no irritation occured
- Lymph node proliferation response: Not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node proliferation
- Criteria used to consider a positive response: Stimulation Index (SI)
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance formulations (w/w) were prepared within 4 hours prior to each dosing. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
The dorsal surface of both ears was topically treated (25 µL/ear) with the test substance concentration, at approximately the same time on each day. The concentrations were stirred with a magnetic stirrer immediately prior to dosing.
The control animals were treated in the same way as the experimental animals, except that the vehicle was administered instead of the test substance. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values for each group calculated and SI values calculated. No statistical analysis performed.
Results and discussion
- Positive control results:
- The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at this laboratory is an appropriate model for testing for contact hypersensitivity
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10%
- Cellular proliferation data / Observations:
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 1101, 1119 and 1012 DPM, respectively. The mean DPM/animal value for the vehicle control group was 907 DPM.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since there was no indication that the test substance elicited a SI = 3 when tested up to 50%, ADCA was not considered to be a skin sensitizer.
- Executive summary:
ADCA was not considered to be a skin sensitizer.
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