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Diss Factsheets
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EC number: 952-692-7 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Thiobis Propanoic Acid Derivatives
The category covers thiiodipropionates that are symmetrically esterified by two linear aliphatic groups ranging in size from C10 to C24
The justification for the category is based on the expectation that the close structural similarity should result in properties that are either similar or follow a pattern that correlates with changes in the molecular weights of the compounds. The category members are high-molecular weight dithiopropionate esters that differ only in the chain length of the dialkyl ester functions and are expected to follow a regular pattern for all endpoints.
Based on the structures and molecularweights of the category members, as well as available data on category members, The predictive methods and extrapolation and interpolation of data within the category are acceptable. Data provided by other sources also demonstrate that these compounds generally have mammalian toxicities that are similar (e.g., acute oral LD 50, acute irritation thresholds, and genotoxicities) or follow a pattern that parallels changes in molecular weight (e.g., repeated-dose NOAEL).
The category is adequately supported based on chemical structure and available data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Didodecyl 3,3'-thiodipropionate
- EC Number:
- 204-614-1
- EC Name:
- Didodecyl 3,3'-thiodipropionate
- Cas Number:
- 123-28-4
- Molecular formula:
- C30H58O4S
- IUPAC Name:
- didodecyl 3,3'-sulfanediyldipropanoate
- Details on test material:
- - Name of test material (as cited in study report): IRGANOX PS 800
- Physical state: solid
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data, virgin
- Weight at study initiation: average 217 g
- Fasting period before study: no data
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water (fresh): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but no further details given
- Humidity (%): controlled, but no further details given
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Females were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation.
- Duration of treatment / exposure:
- Beginning on Day 6 and continuing daily through Day 15 of gestation.
- Frequency of treatment:
- daily
- Duration of test:
During pregnancy until day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 16 mg/kg bw/day (nominal)
- Dose / conc.:
- 74 mg/kg bw/day (nominal)
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20-21, depending on the dose group
- Control animals:
- yes, sham-exposed
- Details on study design:
250 mg/kg of aspirin was used as a postive control.
Attention was called to the fact that this is the seventeenth of a series of reports performed for the US FDA. Eventually, a total of at least 42 compounds were planned to be tested in 21 pairs; each pair being run concurrently against one sham-treated control and one positive control group. Because
of the inherent variability of biological data of the type dealt with. Here, the accumulation and pooling of sequential sets of control values would greatly enhance the statistical value of the findings and the ultimate reliability of the test results.
Examinations
- Maternal examinations:
- Body weights were recorded on Days 0, 6, 11, 15, and 20 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.
- Ovaries and uterine content:
- On Day 20 all dams were subjected to caesarean section under surgical anesthesia, and the numbers of implantation site and resorption sites were recorded. The urogenital tract of each dam was examined in detail for anatomical normality. The number of live and dead fetuses were recorded
- Fetal examinations:
The body weights of the live pups were recorded.
All foetuses were examined grossly for the presence of extemal congenital abnormalities. One-third of the foetuses of each litter underwent detailed visceral examinations employing 10x magnification. The remaining two-thirds were cleared in potassiiam hydroxide (KOH), stained with alizarin red dye and examined for skeletal defects.- Statistics:
- not performed.
- Historical control data:
- not available at the time of the report.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Details on results:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The method part states that clinical signs were assessed, but no further details were given in the results part.
No mortalitiy occured and the body weight development was not affected.
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The method part states that clinical signs were assessed, but no further details were given in the results part.
No mortalitiy occured and the body weight development was not affected.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Key result
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 1600 mg/kg (body weight) of the test
material to pregnant rats for 20 consecutive days had no clearly discernible
effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in
the sham-treated controls - Executive summary:
The administration of up to 1600 mg/kg (body weight) of the test
material to pregnant rats for 20 consecutive days had no clearly discernible
effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in
the sham-treated controls
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