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EC number: 218-216-0 | CAS number: 2082-79-3
- 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
LD50 Oral gavage (rat) > 5000 mg/kg bw (similar to OECD 401, Ciba-Geigy 1981)
LD50 Inhalation (rat) > 1.81 mg/L (aerosol with 45% particles of less than 3 µm in diameter, similar to OECD 403, Ciba-Geigy 1978)
LD50 Dermal (rat) > 2000 mg/kg bw (OECD 402, GLP, Ciba-Geigy 1992)
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:
- November 18, 1981 - December 2, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restriction (limited reporting: purity of the test substance not reported)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited reporting
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-8 weeks
- Mean weight at study initiation: males ca. 181±4.5 g, females ca. 165±10.6 g
- Fasting period before study: yes, overnight
- Housing: 5 per cage
- Diet (e.g. ad libitum): rat food (NAFAG No. 890, NAFAG, Gossau)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE (polyethyleneglycol 400)
- Amount of vehicle (if gavage): 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
- Frequency of observations and weighing: Immediately after administration, clinical signs were observed at hourly intervals till 5 hrs and daily thereafter. Body-weights were recorded immediately prior to dosing (control weights) and at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- no mortalities were observed
- Clinical signs:
- other: Slight sedation and exophthalmos were observed till 5 h post administration. Exophthalmos was also observed from days 8-12 post administration. Slight dyspnoea was observed till day 13 post administration. Slight to moderate ruffled fur was observed till
- Gross pathology:
- No compound related gross organ changes were observed.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days was found to be greater than 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline, acceptable with restrictions (Body weight was not determined after 7 days observation, only after 14 days)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Body weight was not determined after 7 days observation, only after 14 days. Not all particles within respirable range of rats.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Breeding unit
- Weight at study initiation: 227-244 g
- Diet (e.g. ad libitum): rat food, NAFAG, Gogsau SG
- Water (e.g. ad libitum): drinking water
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 50±5
- Photoperiod (hrs dark / hrs light): 14/10 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: For inhalation the rats were kept in separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the aerosol.
- System of generating particulates/aerosols: The aerosol was generated by injecting the solid test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm. at a rate of 20 L/min.
- Method of particle size determination: The size distribution of the particles was measured with a Cascade Impactor with Selectron filters of 25 mm diameter and with a pore size of 0.2 µm at an air flow rate of 17.5 L/min.
- Temperature, humidity in air chamber: 27-28 °C, 19-21 %
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration and the particle size distribution of the aerosol in the vicinity of the animals were monitored at 1 hour intervals throughout the aerosol exposure. The concentration was determined gravimetrically.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 7-12% of the test atmosphere were >7 µm, 38-45 % were 1-3 µm, 32-45 % were 3-7 µm, and 4-15 % were 0-1 µm - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 500, 1025 and 1811 mg/m3 (0.5, 1.025 and 1.811 mg/L)
No higher concentrations possible. - No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Physical condition and incidence of death were monitored throughout an observation period of 14 days. Body weight only before treatment and at 14 days.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.81 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 45% less than 3 µm; no higher concentrations were possible.
- Mortality:
- no mortalities occurred
- Clinical signs:
- other: Exophthalmos, ruffled fur and ventral body position were observed.
- Body weight:
- Animals gained normal body weight.
- Gross pathology:
- No substance related gross organ changes were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 800 mg/m³ air
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:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Remarks:
- CIBA-GEIGY Limited, Short-term Toxicology
- 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
- Mean weight at study initiation: males 261±10.0 g (247-274 g), females 231±13.7 g (211-244 g)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau)
- Water (e.g. ad libitum): drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- TEST SITE
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 24 h
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 g (corresponding approximately to 4 ml)
- Concentration (if solution): 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 - Duration of exposure:
- 24 h
- 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
- Frequency of observations and weighing: mortality was observed twice daily and once on weekends. Signs and symptoms were observed daily. Body weight was determined immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortalities were observed
- Clinical signs:
- other: Piloerection and hunched posture were seen, being common symptoms in acute dermal tests. The animals recovered within 2 days.
- Gross pathology:
- At autopsy, a scurfy ear was noticed in one male. No deviations from normal morphology were found in the remaining animals.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Based on the results, the test substance does not require any classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral exposure route:
In the key study (CIBA-GEIGY, 1981) performed similar to OECD guideline 401, a group of 10 rats (males and females) were orally administered with a single dose of 5000 mg/kg bw and observed for 14 days. No mortalities were observed. Clinical signs included slight sedation, dyspnoea, exophthalmos, ruffled fur and curved body position. All signs were reversible within 14 days of observation period. LD50 for male and female rats was reported to be > 5000 mg/kg bw. The results were supported by two other studies (JR GEIGY 1964), where a group of 10 rats (males and females) were orally administered with 2 or 3 application of test substance (equivalent to 10000 and 15000 mg/kg bw) at intervals of 5 h and observed for 8 days. No mortalities were observed. Signs like drowsiness and dullness were observed.
In another study (CIBA-GEIGY, 1962), rats were given the following doses by stomach tube: 1000, 2150, and 4640 mg/kg bw. Two rats, one male and one female, were used at each level. After seven days the 4640 mg/kg bw level was expanded to 10 animals. All surviving animals were kept for a 14-day observation period. There were no deaths at the two lower levels and only two out of 10 animals died at 4640 mg/kg bw dose level. One death occurred at one hour and the other nine days after dosing. Signs of toxicity consisted of unsteadiness, decreased activity and a sleepy appearance immediately after dosing. All animals appeared normal at 24 hours.
Taking the presented data into consideration (the results of former 3 studies were used for assessment), the test material is considered practically nontoxic to the rat by oral route of administration.
Inhalation exposure route:
In the key study performed similar to the guideline 403, rats were exposed to the test substance aerosols at analytical concentrations of 0.5, 1.025 and 1.811 mg/L for 4 hours (CIBA-GEIGY, 1978). The particle size distribution of the aerosol was as follows: 7-12% were >7 µm, 38-45 % were 1-3 µm, 32-45 % were 3-7 µm, and 4-15 % were 0-1 µm in diameter. No mortalities occurred and clinical sigs included exophthalmos, ruffled fur and ventral body position, and the LC50 for male/female was determined to be > 1.811 mg/l. The results were supported by another study (CIBA-GEIGY, 1973) where a group of rats (9 males and 9 females) were once exposed for 4 h to the test substance aerosols at concentrations of 0.667 mg/l and observed for 7 days. No mortalities occurred and clinical sigs included dyspnoea, trismus, lateral position and slight apathy.
Dermal exposure route:
The key study is a limit dose test with rats performed according to guideline with GLP (CIBA-GEIGY, 1992). Twenty-four hours of dermal exposure to 2000 mg/kg bw under semi-occlusive conditions resulted in no mortalities. The signs included piloerection and hunched posture was seen, being common symptoms in acute dermal tests. The animals recovered within 2 days. These results were supported by another study (CIBA-GEIGY 1962) where rabbits were exposed to 200, 632, and 2000 mg/kg bw under occlusive conditions for 24 h. No mortalities or signs of toxicity were observed during 14 days observation period.
Justification for selection of acute toxicity – oral endpoint
most recent study report
Justification for selection of acute toxicity – inhalation endpoint
most recent study report
Justification for selection of acute toxicity – dermal endpoint
GLP-compliant guideline study
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral, dermal and inhalation toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral, dermal and inhalation toxicity under Regulation (EC) No. 1272/2008.
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