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EC number: 700-397-7 | CAS number: 847488-62-4
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated 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:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
- EC Number:
- 413-750-2
- EC Name:
- A mixture of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
- IUPAC Name:
- 413-750-2
- Reference substance name:
- reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
- IUPAC Name:
- reaction mass of: esters of C14-C15 branched alcohols with 3,5-di-t-butyl-4-hydroxyphenyl propionic acid; C15 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate; C13 branched and linear alkyl 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoate
- Test material form:
- not specified
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 70 days
- Frequency of treatment:
- Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week - Details on study schedule:
- Number of litters per dose/conc.: at ≥ 24 mg/kg or mg/L
- No. of animals per sex per dose:
- Male: 30 animals at 0 mg/kg or mg/L
Male: 30 animals at 10 mg/kg or mg/L
Male: 30 animals at 50 mg/kg or mg/L
Male: 30 animals at 1000 mg/kg or mg/L
Female: 30 animals at 0 mg/kg or mg/L
Female: 30 animals at 10 mg/kg or mg/L
Female: 30 animals at 50 mg/kg or mg/L
Female: 30 animals at 1000 mg/kg or mg/L
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Gestation and birth data.
The length of parturition was slightly longer at 1000 mg/day; in addition difficult parturition was found in one 1000 mg/kg/day treated female. An increase in early resorptions and a higher number of still born with a related lower number of live births was found at 1000 mg/kg/day. No other effects were seen at this and a lower doses.
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
A lower body weight gain and mean daily food consumption was observed at 50 and 1000 mg/kg/day, more evident at 1000 mg/kg/day.
Effects on fetus (Ft generation): One malformed fetus was observed at 1000 mg/kg/day, and it was considered incidental, since it was a pluri-malformed fetus with malformations that sometimes occur in controls. No other effects were seen at this and at lower doses. The higher number of early resorptions and of still born and, the related decrease in live born observed at 1000 mg/kg/day, was interpreted as a consequence of non specific toxicity in parents (lower body weight gain and mean daily food consumption) rather than a specific effect on reproduction. No specific labelling is therefore required.
Applicant's summary and conclusion
- Conclusions:
- The NOEL for the F0 parents is 10 mg/kg/day and for the F1 generation progeny 50 mg/kg/day. No specific labelling is therefore required.
- Executive summary:
The toxicity to reporduction of the structural analogue has been determined in a GLP study with rats according to OECD Guideline No. 415 (one-generation reproduction toxicity study;oral gavage exposure at doses of 0, 10, 50 and 1000 mg/kg bw/d). In this study the effects of the substance on the reproductive performance of male and female rats and on the subsequent development of the F1 generation were assessed
and information on possible teratogenic activity was obtained. A lower body weight gain and mean daily food consumption was observed at 50 and 1000 mg/kg/day, more evident at 1000 mg/kg/day. One malformed fetus was observed at 1000 mg/kg/day, and it was considered incidental, since it was a pluri-malformed fetus with malformations that sometimes occur in controls. No other effects were seen at this and at lower doses. The higher number of early resorptions and of still born and, the related decrease in live born observed at 1000 mg/kg/day, was interpreted as a consequence of non specific toxicity in parents ( lower body weight gain and mean daily food consumption) rather than a specific effect on reproduction. No specific labelling is therefore required. The NOEL for the F0 parents is 10 mg/kg/day and for the F1 generation progeny 50 mg/kg/day.
Since EC 700-397-7 is a near analogue to the test substance (EC 413-750-2), the experimental data from this substance were used in a read-across approach.
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