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Diss Factsheets
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EC number: 454-380-1 | CAS number: -
- 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
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 8.7 mg/kg bw/day (nominal)
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 10.8 mg/kg bw/day (nominal)
- Sex:
- female
- Dose descriptor:
- LOAEL
- Effect level:
- 17.8 mg/kg bw/day (nominal)
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 20.8 mg/kg bw/day (nominal)
- Sex:
- female
Results: F1 generation
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 11.1 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 24.2 mg/kg bw/day (nominal)
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Effects attributed to exposure to Technical Grade HEC 5725 Dihydroxypyrimidine were as follows: 300 ppm P-generation Adults: An increased incidence of non patent cervices, increased uterine weight (absolute/relative) correlating with increased incidence of “dilatation” of uterus upon microscopic observation. Recovery P-Males: Statistically and/or non-statistically significant organ weight trends (>10%) in the recovery males considered to be test substance-related occurred in the prostate (decreased in absolute and relative) and testes (decreased in absolute and relative). These trends were considered to be a test substance-related response since these changes were enhanced compared to the changes seen in the main 300 ppm dose group at the end of the treatment period. Recovery P-Females: A slight effect on fertility was observed, relative to controls, although more difficult to dicern due to the small sample size of animals in this recovery group. Since it is believed that the fertility effect is due to some insult on the female, the fact that females were taken off the treated feed on Gestation Day 0 demonstrates that the effect likely occurred prior to this time. Statistically and/or non-statistically significant organ weight trends (>10%) in the recovery females considered to be test substance-related occurred in the thymus (increased in absolute and relative) and adrenals (decreased in absolute and relative). These trends were considered to be a test substance-related response since these changes were enhanced compared to the changes seen in the main 300 ppm dose group at the end of the treatment period. F1 -Offspring: Organ weight effects included increased spleen weight (absolute/relative) in both genders and as with the P-generation adult females, the F1-female offspring exhibited an increased uterine weight (absolute/relative). F1-generation Adults:. Decrease in epididymal and testicular weight correlating with decreased counts for both organs noted at sperm analysis. Nonstatistical microscopy observations included a slight to marked hypospermia of the epididymis and a slight to moderate abnormal spermatozoa of the testis, relative to controls. F2-Offspring: No test substance-related findings were observed. Reproductive Performance (P and F1): Low fertility only observed in the P-generation. Increased cycle length (more persistence of estrous, designated by cornified cells) correlating with a decrease in the number of days to insemination in both the P and F1 females.
150 ppm P-generation Adults: No test substance-related findings were observed. F1 -Offspring: No test substance-related findings were observed. F1-generation Adults: No test substance-related findings were observed. F2-Offspring: No test substance-related findings were observed. Reproductive Performance (P and F1): No test substance-related findings were observed.
50 ppm P-generation Adults: No test substance-related findings were observed. F1 -Offspring: No test substance-related findings were observed. F1-generation Adults: No test substance-related findings were observed. F2-Offspring: No test substance-related findings were observed. Reproductive Performance (P and F1): No test substance-related findings were observed.
Test Substance-Related Effects at LOAEL:
Reproductive Males: Decrease epididymal count (F1) Decrease testicular count (F1) Decreased epididymal and testicular weights (F1) Hypospermia of epididymis (F1) Abnormal spermatozoa in testes (F1) Females: Decreased fertility (P) Increased incidence nonpatent cervices (P) Increased uterine weight (P) Increased incidence of “dilatation” of uterus (P) Increased cycle length (persistence of estrous) (P, F1) Decrease in days to insemination (P, F1)
Offspring Increased spleen weight (F1- m,f) Increased uterine weight (F1-f)
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