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Diss Factsheets
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EC number: 208-534-8 | CAS number: 532-32-1
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non standard method, limited report
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
- Type of study / information:
- Asthma, rhinitis and urticaria can be provoked by the test substance and the occurrence of asthma induced by the test substance has been reported.
- Endpoint addressed:
- other: respiratory sensitisation after oral challenge
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Fourteen asthma patients with a history of exacerbations occurring after ingestion of orange drinks containing the test substance were given provocation tests by drinking solution of the test substance in water.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- Molecular formula:
- C7H6O2.Na
- IUPAC Name:
- sodium benzoate
- Reference substance name:
- Benzoic acid, sodium salt
- IUPAC Name:
- Benzoic acid, sodium salt
- Details on test material:
- No data given
Constituent 1
Constituent 2
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- The pre-treatment forced-expiratory volume in 1 sec (FEV1) was measured, using a vitalograph spirometer, at least three times at 5 min intervals or unit such time as values differed by not more than 10%. The test substance was dissolved in 250 mL water, equivalent to a large glassful, and sipped to completion over a period of 1 to 2 min. This method of ingestion is the normal way of taking an orange drink, and was preferred to administration by capsule, since, in addition to absorption by the gut, it allows for the possibility of absorption by the oral mucosa, which is a route that must be considered as possible methodological weakness arising from the impossibility of preparing placebo solutions.
The test substance was given in sequential doses of 20 mg, 80 mg and 300 mg in 250 mL water at 40 min intervals. The FEV1 was measured following ingestion of each dose of the test substance at 10 min intervals for 30 min. A decrease in FEV1 of 12% or more below the pretreatment level was recorded as a positive response. - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: ingestion
TYPE OF EXPOSURE MEASUREMENT: The pre-treatment forced-expiratory volume in 1 sec (FEV1) was measured.
EXPOSURE LEVELS: The test substance was given in sequential doses of 20 mg, 80 mg and 300 mg at 40 min intervals.
EXPOSURE PERIOD: 30 min
POSTEXPOSURE PERIOD: 10 min
DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
Results and discussion
- Results:
- Four of the ten patients who reacted to provocation tests were sensitive to the test substance. Although the mean intervals between challenge and maximal depression of FEV1 was 20 min for the test substance, the onset of symptoms and earliest measurable changes usually occurred 10-20 min after the test substance.
Any other information on results incl. tables
The doses of the test substance at which falls in FEV1 occurred, the magnitued of fall in FEV1 and the interval between ingestion and the maximal fall in FEV1 is shown.
Additive |
Case No. |
Dose (mg)* |
Max. FEV1 fall (%) |
Times of max. FEV1 fall (min) |
The test substance |
1 |
120 |
25 |
30 |
2 |
120 |
23 |
20 |
|
4 |
120 |
33 |
20 |
|
7 |
20 |
26 |
10 |
|
mean |
95 |
27 |
20 |
* The smallest dose of the test substance to which the patients responded.
Applicant's summary and conclusion
- Conclusions:
- Four of the ten patients who reacted to provocation tests were sensitive to the test substance, as was measured as a fall in FEV1. The test substance sensitive patients were predominantly middle-aged and the proportion with intrinsic asthma was higher.
- Executive summary:
Fourteen asthma patients with a history of exacerbations occurring after ingestion of orange drinks were given provocation tests by drinking solution of the test substance in water at 20, 80 and 300 mg/250 mL.
Four of the ten patients who reacted to provocation tests were sensitive to the test substance, as was measured as a fall in FEV1. The test substance sensitive patients were predominantly middle-aged and the proportion with intrinsic asthma was higher.
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