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Diss Factsheets
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EC number: 446-640-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- not relevant
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on exposure:
- In this assessment of the effect of ucb L059, a CNS agent, on the
fertility and general reproductive performance of the rat, dosages of O
(Control), 70, 350 and 1800 mg/kg were administered once per day by
gavage. Thirty parent males per group were dosed for 9 weeks prior to
pairing and through to termination. Thirty females per group were
dosed for 2 weeks prior to pairing and through to termination either on
Day 20 of pregnancy or after rearing their young to weaning.
On Day 21 post partum, 12 male and 12 female offspring per group were
selected to form the basis of an F1 generation in which general and
behavioral development, and reproductive capacity were assessed.
Apart from possible exposure in utero and/or through the mothers’ milk,
F1 generation animals received n—o direct treatment. - Details on mating procedure:
- During the mating
female in plastic
At the end of the
UCB 389/911362
period, rats were housed on the basis of one male to one
breeding cages (North Kent Plastics, RM-2 type).
mating period the males were rehoused with their former
cagemates in metal cages (Bowman@) and the females were housed in
individual breeding cages (North Kent Plastics, RM-2 type) prior to
sacrifice of selected animals on Day 20 of pregnancy or for the birth and
rearing of young of remaining females. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- see ADDENDUM 7 testreport
- Duration of treatment / exposure:
- dosages of O
(Control), 70, 350 and 1800 mg/kg were administered once per day by
gavage. Thirty parent males per group were dosed for 9 weeks prior to
pairing and through to termination. Thirty females per group were
dosed for 2 weeks prior to pairing and through to termination either on
Day 20 of pregnancy or after rearing their young to weaning.
On Day 21 post partum, 12 male and 12 female offspring per group were
selected to form the basis of an F1 generation in which general and
behavioral development, and reproductive capacity were assessed.
Apart from possible exposure in utero and/or through the mothers’ milk,
F1 generation animals received n—o direct treatment. - Frequency of treatment:
- Parent males per group were dosed for 9 weeks prior to pairing and through to termination
Females per group were dosed for 2 weeks prior to pairing and through to termination
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 70 mg/kg bw/day
- Dose / conc.:
- 350 mg/kg bw/day
- Dose / conc.:
- 1 800 mg/kg bw/day
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
- yes, plain diet
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
adult animals was unaffected by treatment at dosages up to 1800 mg/kg/day
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 800 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- dermal irritation
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- water consumption and compound intake
- ophthalmological examination
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- neuropathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- effects on the offspring were apparent at 350 and 1800 mg/kg/day. The no
effect level for the general and behavioral development of their offspring
was 70 mg/kg/day.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver, kidney
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Kidney
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver, kidney
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver, kidney
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver, kidney
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 75 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 75 mg/kg bw/day (nominal)
- Organ:
- kidney
- liver
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- yes
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 70 mg/kg bw/day
- Treatment related:
- yes
Applicant's summary and conclusion
- Conclusions:
- It is concluded that, whilst the mating performance and fertility of F0 adult animals was unaffected by treatment at dosages up to 1800 mg/kg/day,
effects on their offspring were apparent at 350 and 1800 mg/kg/day. The no effect level for the general and behavioral development of their offspring
was 70 mg/kg/day. - Executive summary:
This report describes an experiment performed to assess the effect of
ucb L059, a CNS agent, on fertility and general reproductive performance of
the rat and on post natal development and reproductive capacity of the F1
offspring when administered by gavage to FO males and females.
Dosages of O (Control), 70, 350 and 1800 mg/kg/day were chosen based on the
results of a one year oral toxicity study in the rat using these dosages
(UCB/227). In this study (UCB/227) no effect was seen on bodyweight or food
intake, there were post-dose clinical signs of salivation and “paddling” of
forepaws and lethargy at 1800 and 350 mg/kg/day only. The liver and kidneys
were identified as target organs with rats given 70 mg/kg/day being
essentially unaffected. The oral route was chosen by the Sponsor, this
being the intended route of human exposure.
A single batch of ucb L059 was used for this study (designated 901; received
in these laboratories 8 August 1990, 28 November 1990 and 13 March 1991;
purity 99.9%, with an expiry date of June 1995). The test material was
supplied as a white crystalline powder which was stored at room temperature
in the dark. A certificate of analysis is presented as Addendum 6. Samples
of dose solutions were taken on three occasions for analysis of achieved
concentration. Results of these analyses performed by the Sponsor are
presented as Addendum 7.
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.
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