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EC number: 244-007-9 | CAS number: 20749-68-2
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guiedline study and GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 8,9,10,11-tetrachloro-12H-phthaloperin-12-one
- EC Number:
- 244-007-9
- EC Name:
- 8,9,10,11-tetrachloro-12H-phthaloperin-12-one
- Cas Number:
- 20749-68-2
- Molecular formula:
- C18H6Cl4N2O
- IUPAC Name:
- 8,9,10,11-tetrachloro-12H-isoindolo[2,1-a]perimidin-12-one
- Test material form:
- other: solid
- Details on test material:
- content: 99.1 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
- Age at study initiation: 5 weeks
- Weight at study initiation: male 173.6 g; female: 145.3 g
- Housing: in groups of 2 or 3
- Diet ad libitum
- Water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): >10 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on exposure:
- male and female rats weere given the test item for 28 days once daily by gavage. The test item was suspended in poyethylene glycole 400
- Details on analytical verification of doses or concentrations:
- The formulation was prepared as needed taking into account the analytically determined stability of 8 days
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
- Duration of test:
- 30 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test item was administered once daily by gavage to male and female Wistar rats in daily doses of 100, 300 and 1000 mg/kg bw/day suspended in polyethylene glycol 400. The administration volume was 5 ml/kg bw. the animals were observed for mortality and clinical signs, determination of hematology and clinical chemistry data. After termination of treatment animals were subjected to gross and histopathological examination
- Statistics:
- Dunnett, U-test, Het-Dunn ( Dunnett exact test heterogeneous test)
Results and discussion
Effect levels
- Dose descriptor:
- other: NOAEL (reproductive organs)
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: The effects seen in male seminal vesicle at 1000 mg/kg bw/day are evaluated unspecific and stress related; an adverse effect is not assumed; females are without pathological findings.
Observed effects
Histopathology revealed minimally or slightly reduced secretion in the seminal vesicles in 3 out of 5 males at 1000 mg/kg which was not
associated with degeneration. Changes in other male genital organs
(testes, epididymides, prostate or coagulation glands) could not be found
up to and including 1000 mg/kg. Thus, reduced secretion is regarded as unspecific and possibly stress—related. An adverse effect is not assumed.
Applicant's summary and conclusion
- Executive summary:
The Macrolex Rot EG was administered once daily by gavage to male and female Wistar rats in daily doses of 100, 300 and 1000 mg/kg bw/day suspended in polyethylene glycol 400. The administration volume was 5 ml/kg bw. The animals were observed for mortality and clinical signs, determination of hematology and clinical chemistry data. After termination of treatment animals were subjected to gross and histopathological examination.
For general toxicity see the respective section for repeated dose toxicity.
At necropsy there was no evidence at any gross finding that had to be attributed to dosing with the test compound.
Histopathology revealed minimally or slightly reduced secretion in the seminal vesicles in 3 out of 5 males at 1000 mg/kg which was not associated with degeneration. Changes in other male genital organs (testes, epididymides, prostate or coagulation glands) could not be found up to and including 1000 mg/kg. Thus, reduced secretion is regarded as unspecific and possibly stress—related. An adverse effect is not assumed. Therefore, an overall NOAEL (reproductive organs) = 1000 mg/kg bw/day was established.
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