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EC number: 272-249-5 | CAS number: 68784-47-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 410-660-5
- EC Name:
- -
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Remarks:
- distilled water
- Details on exposure:
- Method of administration or exposure: Gavage
Mass median aerodynamic diameter:
Not applicable - Frequency of treatment:
- Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Male: 28 animals at 0 mg/kg or mg/l
Male: 28 animals at 60 mg/kg or mg/l
Male: 28 animals at 300 mg/kg or mg/l
Male: 28 animals at 1200 mg/kg or mg/l
Female: 28 animals at 0 mg/kg or mg/l
Female: 28 animals at 60 mg/kg or mg/l
Female: 28 animals at 300 mg/kg or mg/l
Female: 28 animals at 1200 mg/kg or mg/l
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related clinical signs observed during the course of the study.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- At 1200 mg/kg 3 animals (2 males, 1 female) died as a result of dosing trauma.
At 300 mg/kg two females were found dead and one female was killed in extremis during the maturation phase of the study.
The deaths were consistent with dosing trauma.
At 30 mg/kg one male was killed in extremis during the mating phase of the study. Diuresis was observed on the day of termination. Post mortem observations included distension with haemorrhagic walls of the urinary bladder. In addition the prostrate was oedematous.
One female was killed in extremis during the lactation phase of the study. The deaths was consistent with dosing trauma.
At 0 mg/kg one male was killed in extremis during the post maturation phase of the study. On the day of termination there was clinical evidence of respiratory distress. Post mortem examination showed a jellified mass within the thorax. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant treatment-related intergroup differences in male or female bodyweight gain.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no significant treatment-related intergroup differences in male or female food consumption or food conversion.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no findings observed for selected males or females, either pretest or during week 10 of the study.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no toxicologically significant intergroup differences in male or female blood haematological values.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There were no toxicologically significant intergroup differences in male or female blood chemistry values.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At 1200 mg/kg there was a treatment-related effect on the stomachs of both males and females. Within the forestomach, subepithelial cell infiltrates, occasionally with associated acanthosis of the limiting ridge was observed. With the glandular stomach there was an increased incidence and severity of agglomeration of secretion and goblet cell hyperplasia.
At 300 and 60 mg/kg there were no treatment-related effects on the stomach.
All the remaining morphological changes were those commonly observed in laboratory maintained rats of this age and strain. - Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- There were no significant treatment-related effects upon male or female mating or conception rates. The majority of pre-coital intervals were within the normal four to five day period. The distribution of pre-coital intervals were comparable for all groups.
Details on results (P0)
There were no significant treatment-related effects on the gestation or parturition indices. The distribution of gestation lengths were comparable for all groups, with the majority of gestation lengths being between twenty-two and twenty-three days.
Necroscopy Findings:
There were no significant treatment-related intergroup differences in the type of incidence of macroscopic anomalies observed for both males and females. The types of anomaly observed were those typically observed for this type of study.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Dose descriptor:
- NOEL
- Effect level:
- > 1 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no significant treatment-related intergroup differences in the type and incidence of clinical signs observed for offspring throughout lactation. The clinical signs were those commonly observed in this type of study.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant treatment-related intergroup differences in both the mean total litter weight or mean individual offspring bodyweight throughout lactation. There were no significant treatment-related intergroup differences in offspring maturation, as denoted by the onset and completion of landmarks of development, throughout lactation.
Details on results (F1)
There were no siginificant treatment-related intergroup differences in the mean total number of offspring born.
Subsequent offspring viability throughout lactation was comparable for all groups including controls. There were no significant intergroup differences in the offspring sex ratios at either days 1 or 21 of lactation.
Offspring Reflexological Assessment:
There were no significant treatment-related intergroup differences in offspring reflexological responses.
Offspring Necroscopy Findings:
There were no significant treatment-related intergroup differences in the incidence and type of observations seen at post mortem examination of offspring from either the imterim and terminal necroscopy. The type of findings are those commonly observed for this study type.
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- At a dose level of 1200 mg TILCOM AT35/kg bodyweight there was a minor histopathological effect upon the stomachs of both males and females. There was no effect on either sex during the in-life phase of the study and no effect on either reproductive performance or offspring growth and survival. The no effect level for adult toxicity was therefore 300 mg TILCOM AT35/kg bodyweight. The no effect level for reproductive performances was in excess of 1200 mg TILCOM AT35/kg bodyweight.
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