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Diss Factsheets
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EC number: 200-712-3 | CAS number: 69-72-7
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test conditions are well described and followed the recognized Maximization procedure.
Data source
Reference
- Reference Type:
- publication
- Title:
- The identification of contact allergens by human assay. III. The maximization test: a procedure for screening and rating contact sensitizers
- Author:
- Kligman AM
- Year:
- 1 966
- Bibliographic source:
- J Investigative Toxicol, 47(5), 393-409
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Maximization test: Volunteers are initially exposed to five sequences of alternaing 24 hour irritant (sodium lauryl sulfate) and 48 hour allergen patches applied to the same site under an occlusive patch (induction exposure). Then, volunteers are exposed to a challenge dose for 48 hours. The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 2-hydroxybenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): salicylic acid
no other data
Constituent 1
Method
- Type of population:
- other: prisoners
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Sex: male
- Age: 18 to 50 years
- Race: 90 % of experimental subjects were black - Clinical history:
- no data
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 20 % (induction); 10 % (challenge)
- Volume applied: 1 ml (induction); 0.4 ml (challenge)
- Testing/scoring schedule: The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days
- Removal of test substance: no
EXAMINATIONS
- Grading/Scoring system: Maximization grading (see Table 1 in field "any other information on materials and methods incl. tables)
- Statistical analysis: no data
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, salicylic acid is not a skin sensitizer.
- Executive summary:
In a human maximization test (Kligman AM, 1966), institutional volunteers (prisoners) were dermally exposed to salicylic acid. A panel of 25 healthy adult subjects (18 -50 years) was used. A concentration of salicylic acid of 20 % and 10 % were applied respectively during the induction phase and the challenge test. None subjects showed sensitization after salicylic acid exposure.Under the conditions of this test, salicylic acid is not a sensitizer.
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