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EC number: 436-060-3 | CAS number: - FC 84508 PK
- 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
The available data for test substance indicates a low potential for acute oral (LD50 >2000 mg/kg bw) and dermal toxicity (LD50 >2000 mg/kg bw).
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:
- From Aug. 22, 2000 to Nov. 24, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 wk
- Weight at study initiation: 233± 8.5 g (males); 194± 4.2 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Aug. 22, 2000 To: Sep. 05, 2000 - Route of administration:
- oral: gavage
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance was suspended in the Tylose H 4000 G4 PHA (0.5 % in deionized water) and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight- Yes - Statistics:
- not applicable
- Preliminary study:
- No
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: With exception of discolored orange faeces, between 4 h and Day1 after administration, no clinical signs were observed until the end of the study.
- Gross pathology:
- No gross pathology changes observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the acute oral LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1. and OECD guideline 401 in compliance with GLP.
Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in Tylose H 4000 G4 PHA (0.5 % in deionized water), at a dose level of 2000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. With exception of discolored orange feces, between 4 h and Day 1 after administration, no clinical signs were observed until the end of the study. Development of body weight was not impaired, except one female, which suffered a loss of weight between Day 8 and Day 15. No abnormalities were noted at necropsy.
Under the test conditions, the acute oral LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- From Aug. 23, 2000 to Nov. 27, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, SPF breeding colony
- Age at study initiation: 6-10 wk
- Weight at study initiation: 288± 11 g (males); 212± 12 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate, one animal/cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Aug. 23, 2000 To: Sep. 06, 2000 - Type of coverage:
- semiocclusive
- Vehicle:
- other: Tylose H 4000 G4 PHA (0.5 % in deionized water)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal skin of the area (30 cm2)
- Type of wrap if used: Elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of test substance was moistened with 0.5 mL Tylose H 4000 G4 PHA (0.5 % in deionized water).
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL Tylose H 4000 G4 PHA (0.5 % in deionized water). - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: Clinical signs and body weight - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of 2000 mg/kg body weight. The skin of the animals showed no signs of irritation.
- Gross pathology:
- No gross pathological changes were observed
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats
- Executive summary:
A study was conducted to assess the acute dermal toxicity of test substance in Sprague-Dawley CD rats according EU Method B.3. and OECD guideline 402 in compliance with GLP.
Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.5 mL Tylose H 4000 G4 PHA (0.5 % deionised water), at a dose level of 2000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination.
No mortality was observed in the study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period. The skin of the animals showed no signs of irritation.
Three female animals showed disturbance of body weight gain during the first week of the study. Up to the end of the study (Day 15) the body weight gain returned to normal. One male animal suffered a loss of weight between Day 8 and Day 15, the body weight of all animals increased during the observation period.
Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- 2 000 mg/kg bw
Additional information
Oral
A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1. and OECD guideline 401.
Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in Tylose H 4000 G4 PHA (0.5 % in deionized water), at a dose level of 2000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. With exception of discolored orange feces, between 4 h and Day 1 after administration, no clinical signs were observed until the end of the study. Development of body weight was not impaired, except one female, which suffered a loss of weight between Day 8 and Day 15. No abnormalities were noted at necropsy. The acute oral LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats (Dr. Th. Roth, 2000).
Dermal
A study was conducted to assess the acute dermal toxicity of test substance in Sprague-Dawley CD rats according EU Method B.3. and OECD guideline 402.
Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.5 mL Tylose H 4000 G4 PHA (0.5 % deionised water), at a dose level of 2000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination. No mortality was observed in the study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period. The skin of the animals showed no signs of irritation. Three female animals showed disturbance of body weight gain during the first week of the study. Up to the end of the study (Day 15) the body weight gain returned to normal. One male animal suffered a loss of weight between Day 8 and Day 15, the body weight of all animals increased during the observation period. The acute dermal LD50 of the test substance was found to be >2000 mg/kg in Sprague-Dawley CD rats (Dr. Th. Roth, 2000).
Justification for classification or non-classification
The available data for test substance indicates a low potential for acute oral (LD50 >2000 mg/kg bw) and dermal toxicity (LD50 >2000 mg/kg bw) and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
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