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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-750-2 | CAS number: 171090-93-0 ANOX 1315; ANOX BF; DURAD AX 38
- 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:
- experimental study planned
- Study period:
- Upon receipt of ECHA confirmation.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, C13-15-branched and linear alkyl esters
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
No GLP studies for this endpoint are currently available.
- Available non-GLP studies
No non-GLP studies for this endpoint are currently available.
- Historical human data
To the best of the registrants knowledge, no historical human data associated with this endpoint is available.
- (Q)SAR
There are no available QSAR techniques that can adequately model the endpoint.
- In vitro methods
There are no available in vitro techniques that can adequately model the endpoint.
- Weight of evidence
Available evidence from toxicity studies demonstrates that the substance is of negligible concern for this endpoint. An OECD 415 study investigating morphological, physical and behavioral development of the F1 generation beside to have information on a possible teratogenic activity of the test article. The substance was given by oral route to male rats during the pre-mating and mating periods and to female rats during the pre-mating, mating, gestation and lactation periods and did not induce any apparent toxic effects on male animals. The females of the 50 and of the 1000 mg/kg/day had a lower body weight gain and a lower mean daily food consumption. At 1000 mg/kg/day where maternal toxicity was present, an increase of early resorptions and of still birth was also found. No effects on postnatal survival and development of the F1 live pups were noted at any dose. However, as there is no specific study data to address and confirm this endpoint, additional investigations are required.
- Grouping and read-across
Not applicable; there are no similar substances for grouping and read across purposes.
- Substance-tailored exposure driven testing [if applicable]
The substance is used as a stabilising agent in a variety of applications. As there are consumer and professional user applications, exposure cannot be precluded.
- Approaches in addition to above [if applicable]
Not applicable.
- Other reasons [if applicable]
Not applicable.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
There is no specific study data to address and confirm this endpoint, additional investigations are required.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
8.7. The studies do not need to be conducted if:
– the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented; or
– the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented; or
– the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure.
If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr Cat 1 or 2 and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.
It is considered that fertility assessment is adequately addressed via the exising OECD 415 study; however no further information is available to examine developmental effects. A basic assessment should be suitable for risk investigation of this endpoint, hence an OECD 414 is proposed.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- As per current guideline; rat.
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
Test animals
- Species:
- rat
- Strain:
- not specified
Results and discussion
Applicant's summary and conclusion
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.