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EC number: 690-654-9 | CAS number: 106310-19-4
- 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
Acute oral toxicity:
A single oral administration of the test substance by gavage to male and female rats at 200 mg/kg bw and 2000 mg/kg bw was tolerated without mortalities. Transient clinical signs were observed at doses of 200 mg/kg bw and above. There was no effect on body weight gain. The gross pathology investigations performed at the end of the follow-up period did not afford any findings indicative for a specific test compound effect. The LD50 was determined to be > 2000 mg/kg bw in both sexes.
Acute inhalation toxicity:
The acute inhalation toxicity of the aerolized test item, tested in a GLP-compliant study according to OECD TG 403, is high in rats of both sexes. Lethalities occurred on the day of exposure and, less frequently, during the first observation day. A gender-specific difference in susceptibility to intoxication by inhalation was not be ascertained. The death of the animals was regarded to be causally related to the respiratory tract irritation. The silmultaneous occurence of bradypnea and hypothermia are consistent with an assessment that the substance also induces sensory irritation to the respiratory tract. The LC50 for both sexes combined was calculated to be 348 mg/m³ (4h)./m³.
Acute dermal toxicity:
A single dermal administration of the test substance to male and female rats at the limit-dose 1310 mg/kg (due to local irritation) was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 1310 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:
- June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted: 24 February, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- as amended by Directive 92/69/EEC (31 July, 1992)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Homegeneity and stability was confirmed by analytical examination and assured at room temperature for a period at least 2 hours..
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation: The applied formulation was well mixed by shaken and by pumping the syringe several times before removal of the dosage. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 173-191 g (males), 176 -191 g (females)
- Fasting period before study: ca. 16 hours before and 2 hours after treatment
- Housing: 5 animals/cage (polycarbonat cages type III)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° +- 1.5° C
- Humidity (%): 40-70%
- air exchange rate: at least10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- once 5 ml/kg bw
- Doses:
- 200 mg/kg bw and 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
- Necropsy of survivors performed: yes (gross pathology examination)
- behavior and appearance: several times on the day of treatment and at least once a day thereafter
- body weights: before administration and on day 4 and 8 after administration and afterwards the weekly and all animals that died or were sacrificed. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 200 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: apathy, spastc duct, difficulties with respiration soft faeces dose mg/kg / number with symptom / duration time males 200/ 5/ 2 d – 4d 2000/ 5/ 4h – 2d females 200/ 0/ 2000/ 5/ 4h – 2d
- Gross pathology:
- No findings indicative for a specific test compound effect.
- Executive summary:
A single oral administration of the test substance by gavage to male and female rats at 200 mg/kg bw and 2000 mg/kg bw was tolerated without mortalities. Transient clinical signs were observed at doses of 200 mg/kg bw and above. There was no effect on body weight gain. The gross pathology investigations performed at the end of the follow-up period did not afford any findings indicative for a specific test compound effect. The LD50 was determined to be > 2000 mg/kg bw in both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- only one study available
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:
- August 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann, Borchen, Germany
- Strain: Hsd Win:Wu (SPF-Cpb)
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° +- 2° C
- Humidity (%): approx. 60%
- air exchange rate: at least10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: conditioned compressed air
- Mass median aerodynamic diameter (MMAD):
- 1.4 µm
- Geometric standard deviation (GSD):
- 1.8
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Remarks on duration:
- the post exposure period of observation was a minimum of 2 weeks
- Concentrations:
- Actual Conc.: 0, 356, 401, 555, 1023 mg/m³
Garvimetric Con.: 0, 377, 440, 583, 1077 mg/m³ - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: a minimum of 2 weeks
- Frequency of observations and weighing: clinical signs several times on the day of exposure and twice daily thereafter and before exposure , on day 3, and 7, and weekly thereafter.
- Rectal temperatures: directly after cessation of exposure
- Necropsy of survivors performed: yes
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 348 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- see Table 1: Summary of acute inhalation toxicity
- Clinical signs:
- other: All groups: bradypnoea, laboured breathing, irregular bretahing pattern, reduced motility, nose/muzzle with red incrustations.
- Body weight:
- Significant depressions in body weight gain from all groups on post-exposure day 3 and all groups recovered by day 7.
- Gross pathology:
- Animals sacrified at the end of the observation period: Lungs from individual animals: pinpoint dark red zones, individual dark red zone, slightly collapsed, pale.
- Other findings:
- rectal temperature: All groups that had statistically representative populations of survivors showed significant decrements in rectal temperature from values of controls.
- Executive summary:
The acute inhalation toxicity of the aerolized test item, tested in a GLP-compliant study according to OECD TG 403, is high in rats of both sexes. Lethalities occurred on the day of exposure and, less frequently, during the first observation day. A gender-specific difference in susceptibility to intoxication by inhalation was not be ascertained. The death of the animals was regarded to be causally related to the respiratory tract irritation. The silmultaneous occurence of bradypnea and hypothermia are consistent with an assessment that the substance also induces sensory irritation to the respiratory tract. The LC50 for both sexes combined was calculated to be 348 mg/m³ (4h)./m³.
Reference
Table 1: Summary of acute inhalation toxicity
Group | Sex | Analytical Concentration (mg/m³) | Result | Onset and Duration of Signs | Onset of Lethalities |
1 | male | 0 | 0/0/0 | ||
2 | male | 356 | 0/5/5 | 4h -3d | |
3 | male | 401 | 3/5/5 | 4h -3d | 1d |
4 | male | 555 | 5/1/5 | 4h -3d | 0d - 1d |
5 | male | 1023 | 5/0/5 | 0d | |
1 | female | 0 | 0/0/5 | ||
2 | female | 356 | 0/5/5 | 4h -6d | |
3 | female | 401 | 0/5/5 | 4h -11d | |
4 | female | 555 | 4/4/5 | 5h-9d | 0d - 1d |
5 | female | 1023 | 5/0/5 | 0d |
Values given in the Result column are:
1st = number of dead animals
2nd = number of animals with signs after cessation of exposure
3rd = number of animals exposed
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 348 mg/m³ air
- Quality of whole database:
- only one study available.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- July - August 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 252-261 g (males), 236 -250 g (females)
- Housing: conventionally in polycarbonate cages and during the test period individually.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° +- 1.5° C
- Humidity (%): 40-70%
- air exchange rate: at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- other: the sample is combined with cellulose and mixed to a paste
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30.3 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with soap and water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.9 - 11.28 mg/cm² (males); 10.2 - 10.81 mg/cm² (females)
- Duration of exposure:
- 24 h
- Doses:
- 1310 mg/kg bw (2000 mg/kg bw mixed with cellulose) is the MTD due to local irritation.
- 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: at least once a day (clinical observation); before administration, on day 4 and 8 after administration and then weekly
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 310 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 1310 mg/kg bw is the limit dose level due to local irritation
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: no systemic effect
- Gross pathology:
- The pathological examination at the end of the study showed no change, which refer to a test-substance-specific effect.
- Other findings:
- Local findings:
distinct effects of irritation - Executive summary:
A single dermal administration of the test substance to male and female rats at the limit-dose 1310 mg/kg (due to local irritation) was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 1310 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 1 310 mg/kg bw
- Quality of whole database:
- only one study available
Additional information
Justification for classification or non-classification
Based on the study results for acute oral toxicity no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
Based on the study results for acute oral toxicity also no classification for acute dermal toxicity according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.
With regard to the dermal LD50 -value > 1310 mg/kg bw, which was already determined in 1993, the substance would be allocated to Category 4 according to the numeric criteria. Skin corrosivity prevented an accurate result for classification purposes because with regard to animal welfare reason it was impossible to apply 2000 mg/kg bw. From today´s perspective, according to REACH Regulation column 2 of Section 8.5.3 of Annex VIII the waiving of acute dermal toxicity testing is allowed if the substance does not meet the criteria for classification for acute oral toxicity (see above). No further testing nor classification for acute dermal toxicity is required.
Based on the study results for acute inhahaltion toxicity a classification in Category 2 (H330: Fatal if inhaled) according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted
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