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EC number: 276-896-4 | CAS number: 72828-93-4
- 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
In a GLP guideline study from 1990, the LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings. However, since the dye content was only 48% and the content of active ingredient too low to exclude a classification according to CLP criteria, a second study from 1974 (equivalent to guideline study) was taken into account for a weight-of-evidence approach: under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). Based on both results, the substance is not classifiable according to CLP criteria.
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:
- weight of evidence
- Study period:
- Oct 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Male rats were administered the test substance by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.
- GLP compliance:
- not specified
- 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:
- Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 150-200 g
Temperature and relative humidity: 22 +/- 1.5°C and 60 +/- 5%, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Dose volume applied: 20 mL/kg bw
- Doses:
- 3000, 3500, 4000, 4500, 5000, 6300 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Statistics:
- Probit analysis
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 068 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 3 735 - < 4 418
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 115 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 0/10 at 3000 mg/kg bw, 3/10 at 3500 mg/kg bw, 5/10 at 4000 mg/kg bw, 7/10 at 4500 mg/kg bw, 8/10 at 5000 mg/kg bw, 10/10 at 6300 mg/kg bw
- Clinical signs:
- Sedation, breathing difficulties, seizures
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 13 - 27 Feb 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- "Richtlinie 84/449/EWG (Amtsblatt der Europäischen Gemeinschaften Nr. L 251 vom 19.09.1984, S.93)"
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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:
- Breeder: Winckelmann, Borchen
Acclimatization period: at least 5 d
Age: 8-10 weeks old
Body weight: 174-192 g
Temperature and relative humidity: 22 +/- 2°C and 55 +/- 5%, respectively
Light period: 12h light/12h dark
Diet and water: Altromin 1324 and tap water, ad libitum
Fasting period before study: 16 - 4 h - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was diluted into water and administered at a constant rate (10 mL/kg bw) by gavage
- 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 and weighing: pior to, 1 week after and 2 weeks after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- according to Spärman & Kärber
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 960 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Male: 0/5; female: 1/5 (on day 2)
- Clinical signs:
- Male: none; female: bad general condition, sedation, prone position in 1/5 animals (ca. 8 h after application)
- Body weight:
- No treatment related effects
- Gross pathology:
- Male: no effects; female: gastric mucosa elapsed and all organs in the abdominal cavity blue stained in 1/5 animals
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 115 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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