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EC number: 204-317-7 | CAS number: 119-36-8
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test conditions are similar to the OECD test guideline. The test conditions and the results are well described. Only one dose level was tested by oral route and no positive control was used. Compliance with GLP was not mentioned.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative genotoxicity of six salicylic acid derivatives in bone marrow cells of mice.
- Author:
- Giri AK, Adhikari N, Khan KA
- Year:
- 1 996
- Bibliographic source:
- Mutation Research, 370, 1-9
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- only one dose level was used
- GLP compliance:
- not specified
- Type of assay:
- mammalian germ cell cytogenetic assay
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 from Sigma Chemical Co. (St, Louis, MO)
No other data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Division of laboratory animals, Central drug research institute, Lucknow
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 30 g
- Assigned to test groups randomly: no data
- Fasting period before study: no data
- Housing: no data
- Diet : ad libitum, standard rodent pellet diet (Gold Mohor, Lipton India Ltd., Chandigarh, India)
- Water : ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 28 +/- 2
- Humidity (%): 60 +/- 5
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: solution of gum acacia in water at 2 %
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data - Details on exposure:
- Salicylic acid was suspended with 2% gum acacia in distilled water and gavaged (350 mg/kg bw) to a group of 5 mice (0.3 ml/mouse). Negative control mice were gavaged only 2 % gum acacia in distilled water.
- Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- once
- Post exposure period:
- 24 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
350 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 male mice per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- None
Examinations
- Tissues and cell types examined:
- Cells from the bone marrow were examined.
- Details of tissue and slide preparation:
- After 22 hr of chemical treatment, the animals were injected with colchicine (2 mg/kg) and 2 hr later they were killed by cervical dislocation. Bone marrow chromosomes were prepared and slides were stained with Giemsa. All the slides were coded and 100 well spread metaphase cells
were scored per animal. Mitotic indices (MI) were calculated from 1000 cells/animal. CA were scored. - Evaluation criteria:
- Statistically significant dose-related increase in the number of CA.
- Statistics:
- Student's t-test was used to compare the results.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- none
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the condition of this test, salicylic acid did not induce a genotoxic effect. - Executive summary:
In an in vivo chromosome aberration assay (Giri et al., 1996), Swiss albino male mice were treated with salicylic acid, suspended with 2% gum acacia in distilled water (0.3 ml/mouse), by gavage at the dose of 350 mg/kg. Five mice were used for treated group along with a negative control. Negative control mice were gavaged with 2% gum acacia in distilled water. No significant increase in CA was observed for salicylic acid when compared with solvent control. A significant increase in MI was observed for salicylic acid. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 475.
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