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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 810-021-4 | CAS number: 111304-31-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed in accordance with OECD Gideline No. 423.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- 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:
- yes
Test material
- Reference substance name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- EC Number:
- 810-021-4
- Cas Number:
- 111304-31-5
- Molecular formula:
- C12H11NO5
- IUPAC Name:
- methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate
- Test material form:
- solid: crystalline
- Details on test material:
- Name: Niliden (Nifedipine Intermediate 11)
CAS: 111304-31-5
Batch No.: ND-78
Description: A white to pale yellow crystalline substance
Date of analysis: 10 2014
Expiry date: 10 2015
Storage: in the refrigerator (2-8 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Experimental animals
Species and strain: Crl: (WI)BR rats
Source: Toxi Coop ZRT. Cserkesz u. 90. 103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The wistar rats as a rodent is one of the standard species of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 9 weeks old in first and second step
Body weight range
at starting (first step): 212-215 g
Body weight range
at starting (first step): 207-209 g
Acclimatization time: 12 days in first step, 13 days in second step
Husbandry
Animal health: Only healthy animals were used for the study.
Health status was certified by the study director.
Room: 5/I (E building)
Housing: Group caging (3 animals/cage)
Cage type: Type II polypropylene/polycarbonate.
Bedding: Laboratory bedding
Light: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 10-15 air exchanges/hour by central air condition system
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methyl cellulose solution (1 %)
- Details on oral exposure:
- The test item with a suitable chemical purity, analytical certificate of the product was supplied by the Sponsor.
All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw.
The test item was applied in a concentration of 200 mg/mL. Formulations were prepared just before the administration and were stirred continuously during the treatment. - Doses:
- Starting dose was selected on the basis of the available information of the test item.
The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. - No. of animals per sex per dose:
- Three female rats in the first step at 2000 mg/kg bw dose level, further three female rats in the second step at 2000 mg/kg bw dose level again.
- Control animals:
- no
- Details on study design:
- -Dosages: Starting dose was selected on the basis of the available information of the test item.
-Procedure: A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was witheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
-Duration of the experimental period: 12 days in first step and 13 days in second step of acclimatization, treatment's day, 14 days post-treatment observation period including the treatment day, necropsy on Day 15.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- In group 1 treated with 2000 mg/kg dose clinical sign of reaction comprised of decreased activity (4 cases out of 57 observations), abnormal gait (4/57), incoordination (3/57), blood around the eyes (2/57), decreased righting reflex (5/57), decreased grip- and limb tone (5/57), decreased abdominal tone (2/57), decreased plantary reflex (2/57), blood around the nose (2/57) and piloerection (3/57). Decreased activity (score -2;-3), abnormal gait (score +2,+3) decreased righting reflex (score -2,-3,-4), decreased grip- and limb tone (score -1,-2,-3,-4) decreased body tone (score -1;-2,-3) and piloerection (score +1) occured all animals. Incoordination (score +2,+3), blood around the eyes (score +2,+3), decreased plantary reflex (score -1, -2) and blood around the nose (score +2,+3) were observed in two animals (No.3342, 3350)
These symptoms were observed between Day 1 and Day 2.
In group 2 treated with 2000 mg/kg dose clinical sign of reaction comprised of incoordination (1 cases out of 57 observations), decreased righting reflex (4/57), decreased grip- and limb tone (4/57), decreased body tone (4/57), decreased plantary reflex (4/57) and blood around the eyes (1/57). Decreased righting reflex (-1,-2), decreased grip- and limb tone (score -1,-2,), decreased body tone (score -1,-2) and decreased plantary reflex (score -1,-2) occured in two animals (No.:3394, 3396). Incoordination (score +2) and blood around the eyes (score +2) were observed in animal No.: 3394.
These symptoms were observed between Day 1 and Day 3. Animal No.: 3378 was free of symptoms during the observation period. - Body weight:
- The mean body weight of the animals corresponded to their species and age throughout the study.
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute toxic class method (OECD Guideline 423.) was carried out involving a stepwise procedure with the use of 2000 mg/kg bw dose. The test item is ranked into classes of Globally Harmonized Classification System as GHS category 5 since the LD50 (mg/ kg bw) is above 2000.
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.