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EC number: 601-329-8 | CAS number: 114798-26-4
- 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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although the study was conducted according to GLP and well documented methods, " Practical guide 10: How to avoid unnecessary testing on animals", Section 3.3.2 states it is important that the reliability indicator (Klimisch score) reflects the assumptions of similarity. Thus, a score of 1 (reliable without restrictions) should normally not be used for results derived from read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- DuP 753 was administered in single intraperitoneal doses of 25, 50, 100 or 200 mg/kg to groups of 5 male and female albino rats. Control rats received an equivalent volume of the vehicle. Over a two week period, observations for mortality, clinical signs and body weight were made.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- DuP 753
- IUPAC Name:
- DuP 753
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): DuP 753
- Substance type: bulk powder
- Physical state: solid
- Analytical purity: 99.2%
- Lot/batch No.: INE-3340-15
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY
- Age at study initiation: 8 weeks
- Housing: Individually housed in stainless steel wire mesh cages
- Diet (e.g. ad libitum): Certified Agway Prolab RMH 3000 pelleted food ad libitum (except for fasting prior to necropsy)
- Water (e.g. ad libitum): Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 +/- 2°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: 4 October 1988 To: 19 October 1988
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- DuP 753 was prepared once on the designated day of dosing as a solution in Sterile Water for Injection. Doses were administered to the rats by intraperitoneal injection at a volume/body weight of 2 mL/kg. Control animals received an equivalent volume/body weight of the vehicle. Individual doses of DuP 753 were based on a pre-dose body weight measured prior to dosing.
- Doses:
- 0, 25, 50, 100 and 200 mg/kg
- No. of animals per sex per dose:
- 5 male/5 female
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Page of the study report that describes this is missing
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight,gross pathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- other: NOAEL
- Effect level:
- ca. 100 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- other: Maximum Tolerated Dose
- Effect level:
- ca. 100 - < 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There was no mortality associated with the administration of the vehicle or with doses of 25, 50 or 100 mg DuP 753/kg bw. Drug related mortality was observed in rats treated with 200 mg DuP 753/kg bw. Three males and one female died approximately 3 to 5 days post-dose.
- Clinical signs:
- There were no clinical signs noted in the low dose group (25 mg/kg) that were considered to represent a toxicologically adverse effect of treatment. Mild clinical signs related to DuP 753 were noted in the 50 and 100 mg/kg groups and included soft stools, ataxia and perianal staining. Clinical signs observed in rats treated with 200 mg DuP 753/kg consisted of ataxia, decreased motor activity, perianal staining, urogenital staining, dehydration, soft/mucoidal stools, pale ears, rough coat, material around eyes, mouth, paws and/or nose and labored breathing.
- Body weight:
- A treatment related body weight loss was exhibited in the high dose group (100 mg/kg) male and female groups from Study Day 1 to Study Day 2. Thereafter, the surviving high dose rats gained weight at a rate comparable with that of the control group.
- Gross pathology:
- Gross post-mortem findings considered to be related to DuP 753 were noted in the gastrointestinal tract of the 200 mg/kg group and included: abnormal size (distension) of the jejunum and duodenum, thickened wall of the jejunum and cecum and firm consistency of the contents found in the jejunum and ileum.
Applicant's summary and conclusion
- Conclusions:
- Based on the absence of significant dos-related effects and mortality, the single intraperitoneal no-observable-adverse-effect-level (NOAEL) was considered to be 100 mg DuP 753/kg and the single intraperitoneal maximum tolerated dose (MTD) of DuP 753 was considered to be >100 but <200 mg/kg.
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