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Diss Factsheets
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EC number: 700-953-9 | 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
LD50 oral rat: >2000 mg/Kg bw
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:
- 20 March 2015-21 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted following the OECD Guideline No. 423 and it was subjected to periodic inspections by the Quality Assurance Unit in compliance with the OECD Principles of Good Laboratory Practice (OECD 1998). tudy conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: Bred and reared at INTOX PVT. LTD.
Age at treatment: 9 to 10 weeks
The experimental animal room was supplied with fresh and filtered air, with 10 to 15 air changes per hour. The room was air conditioned with temperature between 19 to 25 °C, relative humidity 30 to 70% and illumination cycle set to 12 hours light and 12 hours dark. Animals were housed in room number AR-31, in the experimental animal facility of INTOX PVT. LTD., maintained under appropriate barriers. Animals were housed in sterilised solid bottom polypropylene cages with stainless steel grill tops facilities for food and water bottle, and with bedding of clean and sterilised paddy husk. Cages were suspended on movable stainless steel racks. Three animals of same dose group were housed in one cage. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Oral route is a route of accidental exposure in humans.
- Doses:
- 300 to 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 females for 300 mg/kg bw
6 females for 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- all animals were observed for signs of toxicity and death, periodically during the first 24 hours with special attention given during the first 4 hours (i.e. at 10 minutes, 30 minutes, 1 hour, 2 and 4 hours following dosing) and thereafter they were observed once a day for 14 days.
The body weights were individually recorded at day 0, day 1, day 7 and aon day 15.
All animals in the study were subjected to a complete necropsy and the gross pathological changes were recorded. - Statistics:
- No statistical analysis was performed because of the small sample size and absence of controls.
- Preliminary study:
- not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Acid Brown 432 did not cause any mortality following treatment on the day of dosing and also throughout the observation period of 14 days following dosing.
- Clinical signs:
- other: Acid Brown 432 did not induce any abnormal clinical signs
- Gross pathology:
- No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the test
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, all animals receiving the highest dose of 2000 mg/kg bodyweight showed no signs of toxicity.
- Executive summary:
This study was performed to assess the acute toxicity of the test article, Acid Brown 432 by single oral gavage administration to Wistar rats and to classify according to the criteria for classification of Regulation 1272/2008/EC. Mortality, clinical signs and bodyweight changes were monitored throughout the study. All animals were examined macroscopically.
According to the test guideline, three fasted female rats were used for each step. The starting dose of 300 mg/kg bw was selected. Three additinal rats were also fed with the same dose and any sign of toxicity and mortality were observed. The third step was a limit dose of 2000 mg/kg bw. None of the doses caused signs of toxicity or mortality.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 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
Only one study is available on the substance. It doesn't show any toxicity at doses of 2000 mg/Kg bw for oral route.
Justification for classification or non-classification
The limit value that can trigger to classification is 2000 mg/Kg bw both for oral and dermal route.
No classification for acute toxicity oral is warranted under Regulation 1272/2008.
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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