Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 454-800-3 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The acute toxicity (LD50) of the test substance in rats is > 250 - < 500 mg/kg bw in males and > 100 - < 250 mg/kg bw in females after oral administration as well as > 250 - < 750 mg/kg bw in males and
> 100 - < 500 mg/kg bw in females after dermal administration (Bomann, 1989). The acute inhalation toxicity (LC50) is > 1404 mg/m3 air ( maximum technically attainable concentration) for male and female rats (Pauluhn, 1989).
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:
- Jan to Feb 1989
- 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:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Stability under test conditions: The formulation was prepared for immediate use and administration was carried out within 1 hour.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Age at study initiation: 7-8 weeks (males), 10-11 weeks (females)
- Weight at study initiation: 162-180 g (males), 173-184 g (females)
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- Males: 100, 250, 500, 750, 2000 mg/kg bw
Females: 100, 250, 500 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Administration volume: 5 mL/kg
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 1, 4, 8 and 14
- Necropsy of survivors performed: yes - Statistics:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 250 - < 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 250 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Males: After treatment with 100 or 250 mg/kg bw no animals died (0/5). After treatment with 500, 750 or 2000 mg/kg bw all animals died (5/5) within 1 day.
Females: After treatment with 100 mg/kg bw no animals died (0/5). After treatment with 250 or 500 mg/kg bw 4/5 or 5/5 animals died within 5 hours. - Clinical signs:
- other: At 250 mg/kg bw and above male and female animals showed the following clinical signs: Apathy, labored breathing, staggering gait, reduced motility, partly abdominal or lateral position, partially low reflexes, lacrimation, closed palpebral fissures, sali
- Gross pathology:
- In the animals died after administration, the following gross pathological findings were recorded: Lungs blown, partly spotted; spleen pale; liver dark; stomach partly with clear or red fluid; partly in the glandular stomach ulcus-like foci, partly reddened mucous membrane or like corroded looking mucous membranes; intestinal tract filled with clear liquid.
No findings were recorded for the animals killed at the end of the follow-up period. - Other findings:
- none specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
According to OECD TG 401 the acute oral toxicity (LD50) in rats is in the range of 250 - 500 mg/kg bw for males and in the range of 100 - 250 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after single oral administration to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The study is GLP compliant and is of high quality (Klimisch score=1)
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:
- Feb 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Age at study initiation: ca. 2-3 months
- Weight at study initiation: approx. 170-210 g
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: polyethylene glyocol / ethanol 50/50 (v/v)
- Mass median aerodynamic diameter (MMAD):
- >= 1.32 - <= 1.51 µm
- Geometric standard deviation (GSD):
- >= 1.81 - <= 1.98
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- analytical concentrations: 131.8, 896.3, 1404.1 mg/m3 air
- No. of animals per sex per dose:
- control groups: 10
dose groups: 5 - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: clinical signs were examined several times on the day of exposure and at least once daily therafter; body weights were measured before exposure, on days 3 and 7, and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: reflex measurements were made on the first post-exposure day. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 404 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum technically attainable concentration
- Mortality:
- No animals died during exposure and post-observation period up to the maximal technical attainable concentration of 1404 mg/m3.
- Clinical signs:
- other: At 132 mg/m3 and above all rats showed slightly reddened noses on the exposure day. There were no signs of a concentration-dependent pronounced amplification of this effect.
- Body weight:
- Body weight development was normal for both sexes.
- Gross pathology:
- No gross pathological findings were observed.
- Other findings:
- The reflex measurements carried out on the first post-exposure day did not reveal any treatment-related changes.
- Interpretation of results:
- other: no acute hazard potential
- Executive summary:
According to OECD TG 403 the acute inhalation toxicity (LC50) is > 1404 mg/m3 air ( maximum technically attainable concentration) for male and female rats. Thus, the test substance revealed no acute hazard potential under the described experimental conditions after a single 4 -hour inhalation exposure to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study is GLP compliant and is of high quality (Klimisch score=1)
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:
- Jan to Feb 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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: Versuchstierzucht Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males), 14-16 weeks (females)
- Weight at study initiation: 208-237 g (males), 207-228 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: max. 5 cm x 6 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin areas were cleaned with soap and water
- Time after start of exposure: ca. 24 hours after start of exposure - Duration of exposure:
- 24 hours
- Doses:
- Males: 100, 250, 750, 2000 mg/kg bw
Females: 100, 500 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 weighing: day 1, 4, 8 and 14
- Necropsy of survivors performed: yes - Statistics:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 250 - < 750 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 100 - < 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Males: After treatment with 100 or 250 mg/kg bw 0/5 or 1/5 animals died within 2 days. After treatment with 750 or 2000 mg/kg bw all animals died (5/5) within 1 day.
Females: After treatment with 100 mg/kg bw no animals died (0/5). After treatment with 500 mg/kg bw all animals died (5/5) within 1 day. - Clinical signs:
- other: At 250 mg/kg bw and above male and female animals showed the following clinical signs: Apathy, labored breathing and reddened eyelids. In addition, in males after 2000 mg/kg bw reflex reduction and strong blood circulation of hairless body parts were seen
- Gross pathology:
- In the animals died after application, the following gross pathological findings were recorded: Liver dark; spleen pale; lungs blown, partly spotted; glandular stomach reddened, partly ulcus-like foci; occasionally stomach filled with liquid mash.
No findings were recorded for the animals killed at the end of the follow-up period. - Other findings:
- none specified
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
According to OECD TG 402 the acute dermal toxicity (LD50) in rats is in the range of 250 - 750 mg/kg bw for males and in the range of 100 - 500 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after acute dermal administration to rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The study is GLP compliant and is of high quality (Klimisch score=1)
Additional information
According to OECD TG 401 the acute oral toxicity (LD50) in rats is in the range of 250 - 500 mg/kg bw for males and in the range of 100 - 250 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after single oral administration to rats (Bomann, 1989).
According to OECD TG 402 the acute dermal toxicity (LD50) in rats is in the range of 250 - 750 mg/kg bw for males and in the range of 100 - 500 mg/kg bw for females. Thus, the test substance is proved to be moderately toxic under the described experimental conditions after acute dermal administration to rats (Bomann, 1989).
According to OECD TG 403 the acute inhalation toxicity (LC50) is > 1404 mg/m3 air ( maximum technically attainable concentration) for male and female rats. Thus, the test substance revealed no acute hazard potential under the described experimental conditions after a single 4 -hour inhalation exposure to rats (Pauluhn, 1989).
Justification for classification or non-classification
Acute toxicity: oral
Based on the study results on acute oral toxicity the following classification according to Annex I of Regulation (EC) No. 1272/2008 is required: Acute Tox. 3 (H301: Toxic if swallowed).
Acute toxicity: dermal
Based on the study results on acute dermal toxicity the following classification according to Annex I of Regulation (EC) No. 1272/2008 is required: Acute Tox. 3 (H311: Toxic in contact with skin).
Acute toxicity: inhalation
Based on the LC50 > 1404 mg/m3 air (no mortality at the maximum technically attainable concentration) a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)