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EC number: 253-256-2 | CAS number: 36888-99-0
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Aug 2012 - 27 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 421
- Deviations:
- yes
- Remarks:
- 20 animals per sex were used
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.3550, July 2000
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
- Limit test:
- yes
Test material
- Reference substance name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- EC Number:
- 253-256-2
- EC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
- Cas Number:
- 36888-99-0
- Molecular formula:
- C16H9N5O6
- IUPAC Name:
- 5,5'-(1H-isoindole-1,3(2H)-diylidene)dipyrimidine-2,4,6(1H,3H,5H)-trione
- Test material form:
- solid: nanoform
- Details on test material:
- purity: >99%
- Purity test date: (analytical report No.: 08L00151)
- Lot/batch No.: 081012P040
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: (P) 1 - 11 wks
- Housing: individually in Makrolon type M III cages, except during mating and postnatal days 0 - 4
- Diet: ground Kliba maintenance diet mouse-rat “GLP”, meal, supplied by Provimi Kliba SA, Kaiseraugst, Switzerland; ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Paliotol Gelb K 2142 was applied as a suspension. To prepare this suspension, the appropriate amount of test substance was weighed out depending on the desired concentration. Then, deionized water was filled up to the desired volume, subsequently released with a high speed homogenizer. During administration of the test substance, preparations were kept homogeneous by stirring with a magnetic stirrer.
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analyses of the test substance preparations were carried out as a separate study at the test facility Competence Center Analytics of BASF SE, 67056 Ludwigshafen, Germany, under the responsibility of a Study Director of this test facility. The study was carried out in compliance with the Principles of Good Laboratory Practice.
The stability of the test substance in deionized water for a period of 5 days at room temperature was proven before the start of the study.
Homogeneity analyses of the test substance preparations were performed in samples of the highest and lowest concentrations at the start of the administration period. These samples also served for concentration control. - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: up to two weeks
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 40 to 55 days
- Frequency of treatment:
- daily, 7 days/week
- Duration of test:
- males: 2 weeks premating and during mating
females: 2 weeks premating, during mating, gestation and 4 days lactation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: limit test with 1000 mg/kg bw was done based on unexpected total implantation loss at that dose in another OECD 421 study (80R0323/08X008)
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day during work days and once on weekends
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule: twice a day during work days and once on weekends
BODY WEIGHT: Yes
- Time schedule for examinations: males: on the first day of dosing and weekly thereafter; females: on the first day of dosing and once weekly during the premating period, on days 0, 7, 14 and 20 of gestation and during lactation on the same day as litters (days 0 and 4 postnatal)
FOOD CONSUMPTION:
- Time schedule: weekly during premating, during gestation and lactation periods on days 0, 7, 14 and 20 (gestation) and 0 and 4 (lactation), no food consumption was determined for males during mating and postmating periods and for females without positive evidence of sperm and without litter
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on lactation day 4
- Organs examined: all gross lesions, ovaries, uterus and oviducts - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes - Fetal examinations:
- - External examinations: Yes: all per litte
- Soft tissue examinations: Yes: all per litter - Statistics:
- For the hypothesis of equal means student's t-test (two-sided) was performed. For the hypothesis of equal proportions Fisher's exact test (one-sided) was applied. For the hypothesis of equal medians one-sided Wilcoxon test was performed. Results were found to be significant at p<0.05.
- Indices:
- Live birth index (%) = (number of liveborn pups at birth/total number of pups born) x 100
Post implanatation loss (%) = (number of implantations - number of pups delivered/number of implantations) x 100
Viability index (%) = (number of live pups on day 4 after birth/number of live pups on the day of birth) x 100
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
Neither parental mortality nor clinical signs were observed during the study.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
No substance related embryotoxic/teratogenic effects were observed until lactation day 4. Slight effects on viability index (96.5% in control and 99.6% in 1000 mg/kg bw/day group) were deemed to be incidental and the rates of liveborn and stillborn pups were evenly distributed about both groups.
Effect levels (fetuses)
- Remarks on result:
- not measured/tested
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
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.