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EC number: 289-450-9 | CAS number: 88895-93-6
- 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 (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 26 Apr - 25 May 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Azelaic acid
- EC Number:
- 204-669-1
- EC Name:
- Azelaic acid
- Cas Number:
- 123-99-9
- IUPAC Name:
- azelaic acid
- Details on test material:
- - Name of test material (as cited in study report): Azelaic acid
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: under ambient conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac
- Weight at study initiation: 318 - 347 g
- Acclimation period: 4 days
Animal room environmental measurements showed, the temperature and humidity were maintained between the specified limits for the duration of the study.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Acetone/PEG400
- Concentration / amount:
- Induction application: 0.25 % (intradermal) and 50.0 % (epicutanous)
Challenge application: 50.0 % (epicutanous)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone/PEG400
- Concentration / amount:
- Induction application: 0.25 % (intradermal) and 50.0 % (epicutanous)
Challenge application: 50.0 % (epicutanous)
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
Intradermal injection: Preliminary irritation studies were carried out to determine concentrations of test material suitable for sensitization challenge: Four male guinea pigs weighing between 348-374 g at the start of the study were injected intradermally on the clipped flanks with 0.1 mL aliquots of 2.0, 1.0, 0.5, 0.25, 0.1, 0.05 % (w/v) test material in corn oil. Approximately 24 hours later the reactions were examined for size in millimetres (length and breath), erythema and oedema.
Occluded patch: Four male guinea pigs weighing between 501-514 g were selected. For each guinea pig three eight millimetre diameter filter paper patches were saturated with the following concentrations: 1.0, 5.0, 10.0 % (w/v) of test material in acetone/PEG400 and applied to the shaved and clipped flanks. The patches were left on for 24 hours and assessments carried out approximately 24 and 48 hours after the patches were removed. The study was repeated using an additional four male guinea pigs weighing between 501-608 g to find a suitably irritant concentration for induction application.
MAIN STUDY
Ten guinea pigs (five male and five female) weighing between 318-347 g were randomly selected for the test group and five guinea pigs (males) were selected to be weight matched controls for challenge. All guinea pigs were examined daily and weighed weekly as an indication of general health.
A. INDUCTION EXPOSURE
- No. of exposures: 2
On day 1, at the intradermal induction test animals were treated with 0.25 % test material. Eight days later, the test and control animals were treated with 10.0 % (w/w) sodium dodecyl sulphate in petrolatum by open application over the induction injection sites. Twenty four hours later the test animals were treated with 50.0 % test material by induction application.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
Eleven days after the induction application the test animals and control animals were challenged with 50.0% test material by occluded patch. - Challenge controls:
- 5 males
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Any other information on results incl. tables
There was no evidence of toxicity of the test substance. Daily examination showed all guinea pigs to be in good health and no significant differences in body weights were observed between the test and control guinea pigs.
As a result of the preliminary irritation tests 0.25 % was selected from the preliminary irritation test to be the highest suitably irritant concentration for the intradermal injection induction. It was not possible to establish a sufficiently irritant concentration of the test material for induction application from the preliminary work, therefore the animals were treated on day 8 of the study with 10.0 % sodium dodecyl sulphate in petrolatum by open application over the induction injection sites, followed twenty four hours later by an induction application patch of 50.0 %. 50.0 % was selected as it was the highest non-irritant concentration for the challenge patch.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- There was no evidence of sensitization reactions in any of the ten test guinea pigs challenged with 50.0 % azelaic acid at challenge. The control animals showed no response to the test material. Under the conditions of this study azelaic acid is a non sensitizer.
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