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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
Endpoint summary
Administrative data
Description of key information
Oral: Multiple studies are available with a LD50 value of >2000 mg/kg in a weight of evidence approach.
Dermal: An acute dermal toxicity study with rabbit (Goldenthal, 1974) which run on analog substance Benzoic acid (65-85-0) is available which is key study. The LD50 was >2000 mg/kg bodyweight.
Inhalation: An acute inhalation toxicity study with rat (Goldenthal, 1974) which run on analog substance Benzoic acid (65-85-0) is available which is key study. The LC50 was >12200 mg/m3.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary, no guideline and no GLP.
- Justification for type of information:
- Please see Read Across Justification document in Section 13.2 of IUCLID
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Study predates approved guidelines.
Five male and 5 female rats of the Spartan strain was used in this test. The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of 12200 mg/m3 test substance. - GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Spartan
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: from 226 to 244 grams
- Fasting period before study: not indicated
- Housing: Animals were housed by sex in groups of 5 in metal cages above the dropping.
- Diet (e.g. ad libitum): Purina Laboratory Chow
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): no data
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Wright Dust Feeder
- Exposure chamber volume: 59.1 liter
- Method of holding animals in test chamber: closed chamber with seperated 4 units of 2 or 3 rats each
- Source and rate of air: Dried and filtered air was passed through the mechanism and directly into the exposure chamber.
- Method of conditioning air: Airflow was regulated by means of a flowmeter.
- System of generating particulates/aerosols: Wright Dust Feeder
- Method of particle size determination: not performed - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- approximately 12200 mg/m3 (The physical properties of the test material preclude the administration of the test compound at higher atmospheric concentrations.)
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 hr, 24 hr and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- none stated
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 12 200 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There were no deaths following a single inhalation dose of the test substance at 12200 mg/m3 air.
- Clinical signs:
- other: Increased motor activity and slight erythema were observed during the 4 hour exposure period. After 4 hours exposure, 1 rat exhibited salivation. After 24 hours and after 14 days all animals appeared normal.
- Body weight:
- Normal body weight gain was observed.
- Gross pathology:
- No information provided.
- Other findings:
- No information provided.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LC50 was considered to be >12,200 mg/m3 air. The test substance would not be considered a highly toxic material by the inhalation route of administration.
- Executive summary:
Five male and 5 female rats of the Spartan strain was used in this test. The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of 12200 mg/m3 test substance.
The LC50 was considered to be >12,200 mg/m3 air. The test substance would not be considered a highly toxic material by the inhalation route of administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 12 200 mg/m³ air
- Quality of whole database:
- 2 (reliable with restrictions)
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited study summary, no GLP, deviations compared to OECD 402
- Justification for type of information:
- See Read Across Justification document in Section 13.2 of IUCLID
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2311 - 2812 grams
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
No additional data
ENVIRONMENTAL CONDITIONS
No information provided - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the back
- % coverage:
- Type of wrap if used: gauze bandages and Saran Wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): undiluted
- For solids, paste formed: no
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 male and 2 female per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed:
- Other examinations performed: body weight,organ weights - Statistics:
- None stated
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: No information provided
- Gross pathology:
- No information provided
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.
- Executive summary:
4 rabbits were dermally exposed (semi-occlusive) for 24 hours to the test substance (2000 mg/kg). Observation for mortality during 24 hours.
The LD50 was considered to be >2,000 mg/kg bw. The test substance would not be considered a toxic substance by the dermal route of administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
Additional information
Oral: 6 studies are referenced in the dossier. These are as follows:
1) Rat LD50 = 2100 mg/kg (Deuel, 1953)
2) Rat LD50 = 3450 mg/kg (Weil, 1953)
3) Rat LD50 = 4070 mg.kg (Smyth, 1948)
4) Rat LD50 = 3140 mg/kg (Loeser, 1977)
5) Rat LD50 = 1714 mg/kg (Hager, 1942)
6) Rat LD50 > 5000 mg/kg (Fabrizio, 1974)
All of the studies showed defencies in the reporting of the test protocol and methods used. Two studies were rated with Klimisch 2 (Weil, 1953 and Fabrizio, 1974), both showing LD50 values > 2000 mg/kg bw. Only the study by Hager (1942) gave a lower LD50. The result of this study is, however, assessed based on data that are only available in secondary references. Therefore it is concluded that the oral LD50 is > 2000 mg/kg bw.
Dermal: No studies on acute dermal toxicity with the test substance are available, but an acute dermal toxicity study with rabbit (Goldenthal, 1974) run on the stuctural analog substance Benzoic acid (65-85-0) is available.
This study showed some deviations from the guideline, but was considered sufficient to determine that the LD50 was >2000 mg/kg bodyweight. Therefore the LD50 for the test substance is concluded to be >2000 mg/kg bw.
Inhalation:
No studies on acute inhalation toxicity with the test substance are available, but an acute inhalation toxicity study with rats (Goldenthal, 1974) exposed to the structural analog benzoic acid dust is available. This study showed slight deviations from the guideline, but was considered sufficient to determine that the LC50 was >12200 mg/m3 (maximum concentration technically possible). Therefore the LC50 for the test substance is set at > 12200 mg/m3
Justification for selection of acute toxicity – inhalation endpoint
Only one read-across study from benzoic acid is available.
Justification for selection of acute toxicity – dermal endpoint
Only one read-across study from benzoic acid is available.
Justification for classification or non-classification
Oral LD50 = >2,000 mg/kg (weight of evidence)
Dermal LD50 = >2,000 mg/kg (actual value read across >2,000 mg/kg)
Inhalation LD50 = >5,000 mg/m3 (actual value read across >12,200 mg/m³)
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is not classified for the acute toxicity endpoint.
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