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EC number: 305-170-2 | CAS number: 94349-52-7
- 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
Based on the findings with the acute toxic class method, an LD50 of > 350 and < 1400 mg/kg bw was determined for male and female Wistar rats (recalculated based on dye content in registered substance (74% w/w) versus tested material (52% w/w)).
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:
- 2000-05-18 to 2000-07-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Deutschland, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 - 12 weeks, female animals approx. 13 - 18 weeks
- Weight at study initiation: males: 178 - 183 g; females: 171 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: ad libitum (Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland)
- Water: ad libitum (tap water)
- Acclimation period: for at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5 and 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium.
CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, some acute oral toxicity was expected. Therefore, a starting dose of 500 mg/kg body weight has been chosen in the first step with 3 male animals. As none of those animals died, 2000 mg/kg body weight were administered to 3 male animals in a second step. Because all animals died at the second step, 500 mg/kg body weight have been tested in a third step with 3 female animals. Because 2 animals survived the third step the study was terminated. - Doses:
- 200, 500 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 17 days
- Frequency of observations and weighing: observations were done at least once each workday; weighing was performed at the start of the study, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 350 - < 1 400 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: recalculated based on dye content of registered substance (74% w/w) versus tested material (52% w/w)
- Mortality:
- All animals of. the 2000 mg/kg dose group died until study day 8. One female animal of the 500 mg/kg dose group died on study day 2.
- Clinical signs:
- other: Male animals: Signs of toxicity noted in the 2000 mg/kg dose group comprised impaired and poor general state, dyspnoea, gasping, apathy, abdominal position, staggering, paresis, tremor, piloerection, smeared fur, diarrhea, reduced feces, exsiccosis, viole
- Gross pathology:
- Necropsy findings of the animal that died at 500 mg/kg comprised moderate dilation of stomach, small intestine and large intestine as well as blue and/or red discoloration of the stomach content. In the animals that died at 2000 mg/kg blue and or red discoloration of intestinal tract content and same organs and tissues was observed. No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 350 mg/kg bw
- Quality of whole database:
- Acceptable and well documented study.
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
In an acute oral toxicity study according to OECD guideline 423 and EU method B.1 tris, single doses of 2000 and 500 mg/kg body weight of test material preparations in doubly distilled water were given to 3 test groups of fasted animals (2000 mg/kg in 3 males, 500 mg/kg in 3 males and 3 females) by gavage in a sequential manner (BASF AG, 2001).
All animals of the 2000 mg/kg dose group died until study day 8. One female animal of the 500 mg/kg dose group died on study day 2. Signs of toxicity noted in the 2000 mg/kg dose group comprised impaired and poor general state, dyspnoea, gasping, apathy, abdominal position, staggering, paresis, tremor, piloerection, smeared fur, diarrhea, reduced feces, exsiccosis, violet discoloured feces and urine. Findings were observed until study day 8.
Signs of toxicity noted in the 500 mg/kg dose group comprised impaired and poor general state, red clammy snout, dyspnoea, gasping, squatting posture, apathy, staggering, tremor, piloerection, smeared fur, red brown discoloured urine. Findings were observed until study day 17.
The mean body weights of the male animals of the 500 mg/kg test group decreased during the first post exposure observation week but increased during the second week.
The mean body weights of the surviving female animals of the 500 mg/kg test group decreased during the first two post exposure observation weeks but increased during the third week.
Necropsy findings of the animal that died at 500 mg/kg comprised moderate dilation of stomach, small intestine and large intestine as well as blue and/or red discoloration of the stomach content. In the animals that died at 2000 mg/kg blue and or red discoloration of intestinal tract content and some organs and tissues was observed.
No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period. Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 500 mg/kg and less than 2000 mg/kg body weight for male and female rats based on the active ingredient. With regard to the actual test item composition the median lethal dose was recalculated to greater than 350 mg/kg and less than 1400 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
GLP and guideline compliant study report
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance needs to be classified and labelled as acute tox. cat. 4, H302 "Harmful if swallowed." under Regulation (EC) No 1272/2008, as amended for the sixth time in Directive EC 605/2014.
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