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EC number: 220-135-0 | CAS number: 2638-94-0
- 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:
- 17 February 1999 - 2 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- At the time the test was performed, no guideline was in force. The test was performed in accordance with the standard method at the time.
- Principles of method if other than guideline:
- The method followed was that described in KIMBER I, HILTON J and WEISENBERGER C (1989) The murine local lymph node assay for identification of contact allergens: a preliminary evaluation of in situ measurement of lymphocyte proliferation Contact Dermatitis 21 215-220 and BASKETTER DA. and SCHOLES E.W. (1992) Comparison of the local lymph node assay with the guinea-pig maximisation test for the detection of a range of contact allergens. Food and Chemical Toxicology 30, 65-69.
- GLP compliance:
- yes
- Remarks:
- expiry date of the test item is not indicated
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4,4'-azobis[4-cyanovaleric] acid
- EC Number:
- 220-135-0
- EC Name:
- 4,4'-azobis[4-cyanovaleric] acid
- Cas Number:
- 2638-94-0
- Molecular formula:
- C12H16N4O4
- IUPAC Name:
- 4,4'-azobis[4-cyanovaleric] acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature in the dark and at 4 °C in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Oxon, England
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 16.5 - 20 g
- Housing: in groups of four mice in plastic cages
- Diet: standard laboratory rodent diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 -21.5
- Humidity (%): 57 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50, 25 and 10%w/v
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
The mice were allocated without conscious bias to cages within the treatment groups.
- Name of test method: Determination of incorporated 3H-methyl thymidine
- Criteria used to consider a positive response:
The test substance is regarded as a sensitiser if at least one concentration of the chemical results in a three-fold greater increase in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance was prepared in AOO (4:1 acetone/olive oil) at the required concentrations freshly on each day of dosing. Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 ul of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days. The test substance was applied to the dorsal surface of each ear using an automatic micropipette. The test substance was spread over the entire dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Responses to the positive control substances hexyl cinnamic aldehyde (HCA) and 2-Mercaptobenzothiazole (MBT), in contemporaneous studies demonstrate the reliability and sensitivity of this assay to detect skin sensitisers in this laboratory.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 50%
Any other information on results incl. tables
CELLULAR PROLIFERATION DATA
- For the 10 % test substance group the DPM count was 4975. For the 25 % test substance group the DPM count was 5952. For the 50 % test substance group the mean DPM count was 4984. THE DPM count of the control was 4485.
DETAILS ON STIMULATION INDEX CALCULATION
- Stimulation index = test/control ratio = the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes
- The test/control ratio of 3 or more was not recorded for any of the concentrations tested. The test item was not considered to have the potential to cause skin sensitisation.
EC3 CALCULATION
- An EC3 value of the test item was not calculated.
CLINICAL OBSERVATIONS:
- No signs of ill health or toxicity were observed.
BODY WEIGHTS
- Bodyweight increases were recorded for all groups of mice over the period of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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