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EC number: 279-505-5 | CAS number: 80584-91-4
- 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 LD50 in rats > 5000 mg/kg body weight.
Dermal LD50 value > 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5.3.80 - 19.3.80
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. No analytical purity given.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (adopted 1981)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RAI f. (SPF) (Ra 25)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: imported from Basle
- Age at study initiation: 5-6 weeks
- Average weight at study initiation: 113 g (males), 102 g (females)
- Fasting before study begin: 18 hours
- Housing: single housing
- Diet: A commercial autoclavable pelleted diet (Labsure CRM rat and mouse nuts), ad libitum.
- Water: Water filtered at 0.45 micron, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle: 20 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations: deaths and clinical symptoms were recorded (at least once daily).
- Necropsy of survivors performed: yes (at the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia) - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and no clinical signs were observed.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were seen at terminal autopsy.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The oral LD50 in rats was determined to be greater than 5000 mg/kg body weight.
- Executive summary:
In an oral acute toxicity study pre-dating GLP, five rats per sex were dosed with 5000 mg/kg of the test article in 0.5% CMC by gavage. Following a 14 day observation period all animals were sacrificed and a gross necropsy was performed. No mortality and no clinical signs were observed. No abnormalities were seen at terminal autopsy. As a result, the oral LD50 in rats was determined to be greater than 5000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable with restrictions.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- A study via inhalation route is not appropriate because inhalation of the substance by humans is unlikely.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2, 1995 - April 4, 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. No data on purity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (adopted 1987)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Short-term Toxicology, CIBA-GEIGY Limited, 4332 Stein / Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 218-228 g
- Housing: individual housing in Macrolon cages, type 3
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2000 mg/kg bw; 4 mL/kg bw
- Concentration: 500 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
- Clinical signs and symptoms: daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred and no clinical signs were observed.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No signs of acute dermal toxicity were observed in this study.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The dermal LD50 value of the test article in rats was to determined to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute dermal toxicity of the test substance was assessed in a GLP-compliant study following OECD guideline 402. The test article was administered to five rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. No signs of acute dermal toxicity were observed in this study. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of the test substance in rats was established to exceed 2000 mg/kg body weight.
Reference
Table 1: Mean body weight of male and female rats at day 0, 7, and 14.
|
Mean body weight (g) ± sd |
Day 0 male |
222 ± 3.9 |
Day 0 female |
225 ± 2.3 |
Day 7 male |
265 ± 3.5 |
Day 7 female |
234 ± 7.3 |
Day 14 male |
309 ± 10.6 |
Day 14 female |
243 ± 9.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable with restrictions
Additional information
Relevant key study for the assessment.
The oral LD50 in rats was determined to be greater than 5000 mg/kg body weight.
Justification for selection of acute toxicity – dermal endpoint
key study. Dermal LD50 value > 2000 mg/kg body weight
Justification for classification or non-classification
According to the criteria of Regulation (EC) No.: 1272/2008, the substance is not classified as acute toxic.
No signal word, hazard pictogram(s) or hazard statement(s) are required.
Also, according to the criteria specified by Directive 67/548/EEC the substance is not classified with regard to acute toxicity. No symbol or risk phrase is required.
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