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Diss Factsheets
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EC number: 440-870-2 | CAS number: 1013-88-3
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- -
- EC Number:
- 440-870-2
- EC Name:
- -
- Cas Number:
- 1013-88-3
- Molecular formula:
- C13 H11 N
- IUPAC Name:
- C,C-Diphenylmethyleneimine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 150 - 300 g (+/- 20%)
- Fasting period before study: at least 16 hours before administration, but water was available ad libitum
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland) ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark / 6.00 am - 6.00 pm light)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4 g/100 ml and 40 g/100 ml
- Justification for choice of vehicle: the test substance is sensitive to hydrolysis
MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition, no pronounced acute oral toxicity was expected. Therefore a dose of 2000 mg/kg bw has been chosen for the first step with 3 male animals. - Doses:
- 2000 mg/kg bw and 200 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 200 mg/kg bw : 14 days, 2000 mg/kg bw : 14 days for males , 15 days for females
- Frequency of observations and weighing: individual body weights were determined shortly before application, weekly thereafter and at the end of the study. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes (withdrawel of food at least 16 hours before killing with CO2)
- Other examinations performed: clinical signs and symptoms were recorded several times on the day of administration and at least once each workday
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- See table 1. No mortality was observed at 200 mg/kg. 2/6 animals died at 2000 mg/kg (2/3 females 0/3 males). There is however no hint for a real sex difference.
- Clinical signs:
- Impaired or poor general state, dyspnoea, apathay, staggering, salivation, exsiccosis, red clammy snout and eyelid and red smeared fur in the anogenital area noted in male or female animals of the 2000 and 200 mg/kg dose group. The surviving animals appeared normal within 6 days after application.
- Body weight:
- The expected body weigt gain has been observed in the course of the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table. 1: Mortality
3 days | 4 days | 14 days | |
200 mg/kg (male) | 0/3 | 0/3 | 0/3 |
200 mg/kg (female) | 0/3 | 0/3 | 0/3 |
2000 mg/kg (male) | 0/3 | 0/3 | 0/3 |
2000 mg/kg (female) | 1/3 | 2/3 | 2/3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (ora, rat) > 2000 mg/kg bw.
- Executive summary:
The study was performed to assess the range of mortality following oral administration of the test substance, applied as an emulsion in olive oil DAB 10 to Wistar rats.
The study procedure was based on the EEC guideline and modified according to the Acute Toxic Class method. To each group of 6 fasted animals (3 males and 3 females) a single oral dose of test material preparation in olive oil DAB 10 at dose levels of 200 and 2000 mg/kg bw was given.
Signs of toxicity noted in male or female animals of the 2000 and 200 mg/kg dose group comprised impaired or poor general state, dyspnoea, apathy, staggering, salvination, exsiccosis, red clammy snout and eyelid and red smeared fur in the anogenital area. These symptoms are considered to be unspecific. The surviving animals appeared normal within 6 days after application. The expected body weight gain has been observed in the course of the study. 2/6 animals died at 2000 mg/kg (2/3 females 0/3 males). There is, however, no hint for a real sex difference. Necropsy of one animal that died was agonal congestion. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
The oral LD50 (male/female) was determined to be > 2000 mg/kg bw.
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