Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 274-157-0 | CAS number: 69851-61-2
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- Dominant Lethal assay
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks on result:
- other: No evidence of dominant lethal effect was observed in the progeny of male mice treated with test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was conducted to evaluate the cytotoxic or mutagenic effects on male germinal cells produced by test substance.
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]
- EC Number:
- 274-157-0
- EC Name:
- N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]
- Cas Number:
- 69851-61-2
- Molecular formula:
- C37H58N2O4
- IUPAC Name:
- N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanamide]
- Details on test material:
- - Purity: Not reported
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Tif: MAG f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals were obtained from closed breeding colony
- Age at study initiation: Female: 2 months; Males: 2 1/2 to 6 months
- Diet: Standard diet (NAFAG No .890)
- Water: Tap water ad litium
ENVIRONMENTAL CONDITIONS
- Temperature : 21 ± 1°C
- Humidity: 60 ± 5%
- Photoperiod (hrs dark / hrs light): 14 hours dark and 10 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: CMC (carboxymethyl cellulose)
- Amount of vehicle: 0.2 mL/10 g of body weight - Duration of treatment / exposure:
- Single exposure
- Post exposure period:
- Each group consisted of 20 males, each of which was placed in a cage with 2 untreated females immediately after treatment. At the end of 1 week, the females were removed and replaced by another group of 2 females. The procedure was continued for six consecutive weeks. The females were daily examined for successful mating indicated by the occurrence of a vaginal plug. The day that the vaginal plug was observed was designated as "day 0" of gestation. The whole time of six "mating periods" comprises all the stages of the maturation of the germ cell from the A-spermatogonia to the mature spermatozoon.
- Males were observed first week after administration of test substance for general condition and symptomatology.
- Autopsy of females was done and progeny were examined.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 other: mg/kg
- Dose / conc.:
- 3 000 other: mg/kg
- No. of animals per sex per dose:
- 20 males/group
- Control animals:
- yes, concurrent vehicle
Examinations
- Statistics:
- - Student's t test or Mann-Whitney u-test is used to compare the total no of implanatations indicating possible pre-implantation losses
- X²-test or fischer's exact test is used to compare total number of mated and pregnant dams or embryonic deaths.
- Experimental data, particularly on the number of implantations and early embryonic deaths were compared with spontaneous data of a cummulative of treated controls observed over a longer period of time (autopsy on day 18 of pregnancy).
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks on result:
- other: No evidence of dominant lethal effect was observed in the progeny of male mice treated with test substance.
- Additional information on results:
- The females mated to males which had been treated with the test substance did not differ significantly from the females mated to control, neither in mating ratio nor in the number of implantations and embryonic deaths (resorptions).
Applicant's summary and conclusion
- Conclusions:
- No evidence of dominant lethal effects were observed in progeny of male mice tretaed with test substance.
- Executive summary:
The test was conducted to evaluate the cytotoxic or mutagenic effects on male germinal cells produced by test substance The test substance was administered orally by intubation in single doses to male albino mice which were then mated to untreated females from the same strain over a period of six weeks. At the end of each week the females were replaced by new ones. Doses of 1000 and 3000 mg/kg were given. The test was done to evaluate any cytotoxic or mutagenic effects on the male germinal cells as expressed by the loss of pre-implantation zygotes as well as by the rate of deaths of post-implantation stages of embryonic development.
The results showed that the females mated to males which had been treated with the test substance did not differ significantly from the females mated to control, neither in mating ratio nor in the number of implantations and embryonic deaths (resorptions). No evidence of dominant lethal effect was observed in the progeny of male mice treated with test substance.
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.