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EC number: 424-650-3 | 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
Endpoint summary
Administrative data
Description of key information
OECD guideline, GLP-compliant studies were available for acute oral toxicity and acute dermal toxicity. In both studies the LD50 values exceed the limit dose of 2000mg/kg.
It is not appropriate to include an LD50 value for the chemical safety assessment above as this is determined to be greater than the highest concentration tested.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- March 22, 1996
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Dated 31 July 1992
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier: Charles River Wiga, Germany
Age: 5-6 weeks old upon arrival
identification: earmarked
Caging: five animals per cage (stainless stell cages, fitted with wire-screen floor and front)
Acclimatization: 9 or 13 days
Lighting: 12 hours light/dark cycle
Temperature: 22 +/- 3C
Ventilation: ca. 10 air changes/hr
Diet: standard chow ad libitum
Water: tap water ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- Animals were dosed with a dosing volume of 10 ml/kg bw of a 200 mg/ml suspension of test material in maize oil to obtain the 2000 mg/kg dose level. The exact amount of the test substance to be dosed was calculated for each animal and administered by means of a syringe, by oral gavage. Animals fasted overnight prior to dosing and 4 hours after.
- Doses:
- 2000 mg/kg limit dose
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Animals were observed for mortality 14 days post exposure.
Body weights of each animal were recorded immediately before dosing on day 0 and in the surviving animals on days 3, 7 and 14 of the study.
Animals were sacrificed on day 14 with CO2 and subjected to gross pathology. - Preliminary study:
- No mortality observed in 2 males.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female was found dead on day 3
- Clinical signs:
- other: blepharospasm in two males was observed prior to death, the female showed sluggishness, blepharospasm, dyspnoea and coma
- Gross pathology:
- No treatment related gross alterations was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since only one animal died during the 14 -day observation period, the oral LD50 of the test material is considered to exceed 2000 mg/kg body weight, in both male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- EEC Directive 92/69/EEC, dated 31 July 1992
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Febraury 24, 1992
- 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: Charles River Wiga, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 5-6 weeks
- Weight at study initiation: mean 201
- Housing: stainless steel cages, fitted with wire-screen floor and front
- Diet (e.g. ad libitum): standard rodent diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50-70%
- Air changes (per hr): ca. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 January 1997 To: 4 February 1997 - Type of coverage:
- occlusive
- Vehicle:
- maize oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4 x 5 cm
- % coverage: at least 10% of total body surface
- Type of wrap if used: plastic foil, adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residues removed with water
- Time after start of exposure: ca. 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5ml/kg
VEHICLE
- Maize oil - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- 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: Day 0, 3, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Skin reactions were evaluated by the method of Draize et al (J. Pharamcol. Exp Ther. 82 (1944) 377-390)
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- 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: Signs of toxicity related to dose levels: No treatment related effects were observed. All animals gained weight during the 14-day observation period. Some animals showed a slight dip in body weight on postdosing day 3.
- Gross pathology:
- Effects on organs:
No gross abnormalities were observed. - Other findings:
- Signs of toxicity (local):
Males: slight erythema.
Females: slight to moderate erythema, slight or moderate
encrustations and very slight or slight oedema during the
first week after exposure. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study, the LD50 value was determined to be >2000 mg/kg for the test substance
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
It is not appropriate to include a oral and/or dermal LD50 value for the chemical safety assessment above as this was determined to be greater than the highest concentration tested on both studies.
Justification for classification or non-classification
The LD50 value in the acute oral and dermal studies was >2000 mg/kg and therefore warrants no classifications for these endpoints under the CLP regulation (1272/2008 EC, as amended). No study available to assess inhalation toxicity and therefore not classified based on "data lacking" for this endpoint.
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.
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