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EC number: 404-110-3 | 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
In male and female rats the oral LD50 is > 2000 mg/kg bw. LD50 in male and female rats after dermal exposure was determined to be > 2000 mg/kg bw. No study on acute toxicity after inhalation exposure is available.
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 27 Feb 1989 to 13 Mar 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 401), according to GLP
- 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:
- (Commission Directive 84/449/EEC, adopted 25 April 1984)
- 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: HOECHST AG, Kastengrund, Germany
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation: males: mean 191 +/- 4 g; females: mean 180 +/- 8 g
- Fasting period before study: yes
- Housing: groups of 5 per sex
- Diet (ad libitum): Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not stated, fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 2% starch mucilage
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension
MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg bw - 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: daily; weighing: weekly
- Necropsy of survivors performed: yes - Statistics:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died after application of limit dose
- 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:
- No clinical signs of toxicity were observed.
The faeces of both sexes was discolored black until day 2 of study. - Body weight:
- Body weight gain was within the normal range.
- Gross pathology:
- No macroscopic findings were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 in male and female rats was > 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was examined in Wistar rats (5 per sex) in a study according to OECD guideline 401 and GLP. After gavage application of 2000 mg/kg bw neither deaths nor clinical symptoms occurred.The faeces of both sexes was discolored black until day 2 of study. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Under the conditions of this study, the oral LD50 in male and female rats was > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable LD50 > 2000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- This information is not 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 02 Mar 1989 to 16 Mar 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 402), according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (adopted 24 February 1987)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (Council Directive 84/449/EEC, adopted 25 April 1984)
- 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: HOECHST AG, Kastengrund, Germany
- Age at study initiation: males: approx. 8 weeks; females: approx. 9 weeks
- Weight at study initiation: males: mean 200 +/- 5 g; females: mean: 193 +/- 4 g
- Fasting period before study: no
- Housing: individually
- Diet (ad libitum): Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not stated, fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- (PEG 400 as moistener)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100 %
- Type of wrap if used: aluminium foil, fixed with an elastic plaster bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.4 g
- For solids, paste formed: yes, with polyethylene glycol 400 (ratio: 1 g test item+ 0.8 mL PEG 400) - 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: daily; weighing: weekly
- Necropsy of survivors performed: yes - Statistics:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died after application of limit dose
- 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:
- No clinical signs of toxicity were observed.
During the first five days of the observation period the treated skin surface exhibited a violet colour. - Body weight:
- Body weight gain was within the normal range
- Gross pathology:
- No macroscopic findings were observed
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the dermal LD50 in male and female rats was > 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test item was examined in Wistar rats (5 per sex) in a study according to OECD guideline 402 and GLP. After 24 h application of 2000 mg/kg bw neither deaths nor symptoms occurred till the end of the 14 days observation period. During the first five days of the observation period the treated skin surface exhibited a violet colour. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes. Under the conditions of this study, the dermal LD50 in male and female rats was > 2000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable LD50 > 2000 mg/kg bw
Additional information
Reliable studies exist for both oral and dermal exposure, indicating no toxicity at the limit dose (2000 mg/kg bw) tested in these studies. Oral: A reliable study (RL1, according to guideline and GLP) did not observe mortality or toxic effects at 2000 mg/kg bw in male and female rats (Hoechst, 1989). Therefore the LD50 is > 2000 mg/kg bw. Dermal: A reliable study (RL1, according to guideline and GLP) did not observe mortality or toxic effects at 2000 mg/kg bw in male and female rats (Hoechst, 1989). Therefore the LD50 is > 2000 mg/kg bw.
Inhalation: No study is available
Justification for selection of acute toxicity – oral endpoint
Guideline study (OECD TG 401), according to GLP
Justification for selection of acute toxicity – dermal endpoint
Guideline study (OECD TG 402), according to GLP
Justification for classification or non-classification
No classification on acute oral and dermal toxicity according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC is required as the oral and dermal LD50 is > 2000 mg/kg bw. No information is available for inhalation exposure.
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