Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 412-570-1 | CAS number: 119462-56-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- other: subacute
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October-November 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MHW-MITI (1986)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Batch no: 910312 (see CoA attached)
Purity: 88±3% (m/m)
Other: mono-citracon-mono-itaconimide isomer: 6.5±2% (m/m)
Unknown: 5.5±2% (m/m)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- Method of administration: gavage
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 50, 200 mg/kg bw
Basis:
other: nominal in maize oil
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day Male: 5 animals at 10 mg/kg bw/day Male: 5 animals at 50 mg/kg bw/day Male: 10 animals at 200 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day Female: 5 animals at 10 mg/kg bw/day Female: 5 animals at 50 mg/kg bw/day Female: 10 animals at 200 mg/kg bw/day
5 animals/sex of the control and high dose group were treated for 28 days and then kept for a 14-day recovery period. - Control animals:
- yes, concurrent no treatment
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Four male and one female animal from the high dose group
were foud dead or humanely killed. Ante mortem sighns were
rales, gasping and abdominal distension, hunched posture and pilo-erection. The surviving animals of the high dose group showed salivation,
ungroomed appearance and pilo-erection. The mid-dose animals showed salivation and isolated incidences of pilo-erection, hunched posture and
ungroomed fur. Of the low dose group three rats showed salivation.
Laboratory findings: Haematology was unaffected. In the high dose group aspartate asmino-tranferase activity and plasma urea concentration
were slightly higher in the animals killed at day 28. These differences were not observed at the end of the 2-week reversibility period.
Effects in organs: No treatment related macropathological effects observed.
Histopathology: In the rats from the high dose level, hyperkeratosis and acanthosis in the keratinised region of the stomach were seen. Although the findings were still evident in animals 2 weeks after treatment had ceased, their frequency was much reduced.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Clear toxicity including mortality was observed at 200 mg/kg bw, limited clinical signs were observed at 50 mg/kg bw, whereas no significant effects were seen at 10 mg/kg bw. As such the NOAEL is 50 mg/kg bw, and the NOEL 10 mg/kg bw.
Classified as: Not classified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.