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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline 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:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
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 oral exposure:
- The test item was administered 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 5ml/kg bw.
- 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 day
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5 per sex 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
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Inspection of Animals for Morbidity and Mortality twice daily
General Clinical Observations (in cage) daily
Detailed Clinical Observations including
Open Field Observation (OFO) weekly
Determination of:
Body Weight(s) daily
Food Consumption weekly
Water Consumption weekly
Clinical Pathology:
---Hematology; day 29, 30
Differential blood count, erythrocyte morphology, erythrocyte count, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, hemoglobin concentration, hematocrit, leukocyte count, reticulocyte count, thrombocyte count, thromboplastin time (Hepato-Quick).
----Clinical Chemistry; day 29, 30
Alanine aminotransferase, alkaline phosphatase, albumin, total bilirubin, cholesterol, creatinine, total protein, urea, glucose, potassium, sodium, gall acids.
Functional Observation Battery: day 23, 24
Motor/Locomotor Activity: day 23, 24 - Sacrifice and pathology:
- Necropsy: day 29, 30
determination of organ weight and calculation of relative organ weight:
Brain, heart, liver, spleen, kidneys (both), thymus, adrenal glands (both), epididymides (both), testes (both), prostate, seminal vesicles (with coagulation glands), ovaries/oviducts (both) and uterus/cervix.
gross and histopathological examination
all weighed organs and additionally
caecum, colon, duodenumeyes, femur with bone marrow, joint, ileum, jejunum, larynx, lungs, lymph nodes mandibular mesemteric iliacale, optic nerves, pancreas, Peyer's patches, rectum, siatic nerve - Statistics:
- Dunnett, U-test, Het-Dunn ( Dunnett exact test heterogeneous test)
Results and discussion
Results of examinations
- Details on results:
- ---Mortality
Survival was not affected in all dose groups
---Clinical findings
No findings in detailed clinical observations were observed
In-cage observations revealed changes in feces color (reddish particles) in males and females of the 300 mg/kg bw. dose group starting on day 3 and in the 1000 mg/kg bw dose group starting on day 2 up to termination.
---Body weight development
Body weights were not affected by the treatment with Macrolex Rot EG at doses up to 1000 mg/kg bw
---Hematology
Red and white blood parameters including blood coagulation were not toxicologically relevantly changed up to 1000 mg/kg bw..
---Clinical Chemistry
Clinical chemistry revealed a decrease of alkaline phosphatase (APh) in dosed females starting at 100 mg/kg bw. and being statistically significant at 300 and 1000 mg/kg bw. A decrease in APh is not considered as toxicologically relevant. All other parameters including electrolytes were in the normal range
---Organ weights
No toxicological relevant changes in absolute and relative organ weights could be observed.
---Gross and histopathological evaluation
At necropsy, there was no evidence of 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 bw. 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 bw. Thus, reduced secretion is regarded as unspecific and possibly stress-related. An adverse effect is not assumed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No relevant adverse effects could be observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Macrolex Rot EG was administered by gavage to 5 male and 5 female Wistar rats per dose group indayily doses of 0, 100, 300, 1000 mg/kg bw/day suspended in polyethylene glycole 400 (vehicle) for a period of 28 days. The study was concucted in compliance with OECD TG 407 under GLP conditions.
Survival was not affected by treatment with Macrolex Rot EG and no clinical signs were observed. The observed decreased alkaline phosphatase in females was not considered relevant because neither all other clinical chemistry data nor hematology gave evidence for treatment related effects up to 1000 mg/kg bw. Starting at the mid dose of 300 mg/kg bw,. all animals of both sexes showed changes in feces color (reddish particles), which is a consequence of the strong red color of the test item and thus is not considered as adverse effect. Histopathology revealed minimally to slightly reduced secretion in the seminal vesicles in 3 out of 5 males at 1000 mg/kg bw which was not associated with degeneration of seminal vesicles. Changes in other male genital organs (testes, epididymides, prostate or coagulation glands) could not be found up to and including 1000 mg/kg bw.. Therefore, reduced secretion is regarded as unspecific and possibly stress-related. An adverse effect is not assumed. Female reproductive organs were not affected up to 1000 mg/kg bw/day.
In conclusion, under the conditions described above, the no-adverse-effect-level (NOAEL) for male and female rats after 4 -week daily oral treatment by gavage with Macrolex Rot EG is 1000 mg/kg bw/day.
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