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EC number: 237-335-9 | CAS number: 13752-51-7
- 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:
- screening for reproductive / developmental toxicity
- Remarks:
- other: Repro/Developmental screen
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[(morpholinothio)thioxomethyl]morpholine
- EC Number:
- 237-335-9
- EC Name:
- 4-[(morpholinothio)thioxomethyl]morpholine
- Cas Number:
- 13752-51-7
- Molecular formula:
- C9H16N2O2S2
- IUPAC Name:
- morpholin-4-yl morpholine-4-carbodithioate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: (P) x wks; (F1) x wks
- Weight at study initiation: (P) Males:292-334 g; Females: 173-223 g; (F1) Males: x-x g; Females: x-x g
- Fasting period before study: none
- Housing:Upon arrival, the animals were housed in groups of five by sex. During the mating period, animals were housed one male to one female percage. Following evidence of successful mating, the males were returned to their original cages. The females were housed individually.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 15%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 May 2004 To: 27 June 2004
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): Once
- Mixing appropriate amounts with (Type of food): PMI 5002 - Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: up to 14 days
- Proof of pregnancy: vaginal plug or sperm in vaginal smear
- After successful mating each pregnant female was caged (how): individually
- Any other deviations from standard protocol: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of OTOS in the dietary admixtures was determined by high performance liquid chromotography (HPLC) using an external standard technique
- Duration of treatment / exposure:
- The test material was administered in the diet throughout maturation, mating, gestation and up to Day 4 post partum
- Frequency of treatment:
- Continuously in the diet
- No. of animals per sex per dose:
- 10 male and 10 female rats per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale:based on available toxicity data.
- Rationale for animal assignment (if not random):randomisation procedure based on stratified bodyweights and the group mean body weights were then determined to ensure similarity between the dose groups.
- Other:
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily during normal working week and once daily on weekends and public holidays
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: During the maturation and mating period the parental generation animals were weighed weekly. Following mating the parental males were weighed weekly until termination. Parental generation females showing evidence of mating were weighed on Days 0,7,14 and 20 post coitum. Parental generation females with a live litter were weighed on Days 1 and 4 post partum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes - Oestrous cyclicity (parental animals):
- not measured
- Sperm parameters (parental animals):
- Parameters examined in all adult males
:
testis weight, epididymis weigh, sperm - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities,
GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.] - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals subject to confirmation of successful mating
- Maternal animals: All surviving animals on Day 5 post partum
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated below were weighed
Epididymides
Testes
The corpora lutea of all ovaries from pregant females were counted and the uterine implantation sites were counted. - Postmortem examinations (offspring):
- SACRIFICE
These animals were subjected to postmortem examinations macroscopic on Day 5 post partum
GROSS NECROPSY
- Gross necropsy consisted of[external and internal examinations including the cervical, thoracic, and abdominal viscera.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 600 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Systemic Toxicity
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 600 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Reproductive Toxicity
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Administration of the test substance to male and female rats throughout maturation, mating, gestation and early lactation phases of reproduction resulted in an initial reduction in food consumption leading to a transient reduction in bodyweight gain at 600 ppm. This is not considered to be an adverse effect as food consumption and bodyweight gain were comprable to controls by the second week of treatment. There were no histopathological changes in the tissues examined. There was no effect on offspring viability, growth and development. The No Observed Adverse Effect Level for adults was 600 ppm. The No Observed Effect Level for offspring was 600 ppm.
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