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EC number: 252-346-9 | CAS number: 35074-77-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-06-29 to 1978-10-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: None GLP but equivalent to guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: WILSON, J.G., in: Teratology, Principles and Techniques; J.G. Wilson and J. Warkany eds., The University of Chicago Press, Chicago and London, 1965, pp. 265-277.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DAWSON, A.B., Stain Tech. 1 (1926), 123-124.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SALEWSKI, E.., Arch. exp. Path. Pharmak. 247 (1964), 367-368.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 252-346-9
- EC Name:
- Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 35074-77-2
- Molecular formula:
- C40H62O6
- IUPAC Name:
- 6-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}hexyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Female albino rats (Tif: RAIf (SPF)) obtained from a closed breeding colony
- Age at study initiation: 2 months
- Weight at study initiation: ca. 190 g
- Housing: Throughout the experiment the successfully mated females were kept in groups of 5 in Macrolon cages in an air-conditioned room.
- Diet: ad libitum, Nafag No. 890
- Water: ad libitum, tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- VEHICLE
- Amount of vehicle: 2 % solution from own stocks - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Before test start the female rats were mated overnight with males of proven fertility in a ratio of 1 male : 3 females. The day on which spermatozoa were found in the vaginal smear or a vaginal plug has occurred was designated as "Day 0" of pregnancy.
- Duration of treatment / exposure:
- Day 6 to day 15 of pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 750 and 2000 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25 female animals per dose
- Control animals:
- yes
- Details on study design:
- In order to determine the dose levels for the main study, a preliminary experiment was carried out on 10 fertilized albino rats at the dose of 2500 mg/kg, given orally by intubation from day 6 until day 15 of pregnancy, inclusive. The dams of this high dose group reacted to treatment by a marked decrease in body-weight gain and food consumption. So far as the progeny were concerned, a reduction in foetal average weight was noted.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily examination
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily examination
BODY WEIGHT: Yes
- Time schedule: daily examination
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined at a dose-related fashion.
- Time schedule: examinations on days 6, 11, 16 and 21
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: ovaries, uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: 1/3 live foetuses
- Skeletal examinations: Yes: 2/3 live foetuses
- Head examinations: No - Statistics:
- The Chi-square test was used together with the Yates correction to compare the sex ratios of the litters with the vehicle controls.
- Indices:
- No indices were determined.
- Historical control data:
- Yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Throughout the period of treatment food intake was reduced in the three dose groups. At the 750 mg/kg bw/d dose and the 2000 mg/kg bw/d dose the body weight gain was diminished, in addition.
The implantation rates were comparable for all groups. In one dam of the 750 and 2000 mg/kg bw/d dose group each haemorrhagic degeneration of implantation sites (deciduomata) was noted. One dam with deciduomata was observed among the rats of the cumulative control.
The rates of foetalethality (resorptions) were comparable for all groups.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The sex ratios of the foetuses were not significantly altered when compared with the vehicle control. At the highest dosing group the average weight of the foetuses was slightly but significantly diminished. The gross examination of the foetuses revealed one omphalocele in one foetus of the highest dosing group and the control group each. This type of malformation was also found in 2 out of 3533 foetuses of the historical control data.
No pathological changes of viscera were found in the experimental groups, including the vehicle control. Some anomalies were noted, however, in the historical control.
Regarding the skeletal assessment, the only clearcut deviation from the vehicle control is assumed to manifest in an increased number of not yet ossified phalangeal nuclei at the 2000 mg/kg bw/d dose. Some skeletal anomalies were observed in the historical control.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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