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EC number: 218-216-0 | CAS number: 2082-79-3
- 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable with guideline, acceptable with restrictions (gravid uterus weight, number of corpora lutea and fetal sex were not examined)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- gravid uterus weight, number of corpora lutea and fetal sex were not examined
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 218-216-0
- EC Name:
- Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 2082-79-3
- Molecular formula:
- C35H62O3
- IUPAC Name:
- octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 240 g
- Housing: 5/cage
- Diet (e.g. ad libitum): standard diet, Nafag No.890
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±0.5
- Humidity (%): 56±5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 2%
- Amount of vehicle (if gavage): 1 ml/100 g bw - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:3
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Frequency of treatment:
- single
- Duration of test:
- GD 6-15
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 500, 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 25 for all test groups, 30 for control group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations: general condition, symptoms, mortality
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: ovaries and uterus (mucosa and contents, including amniotic fluid and placentae), the foetuses were subjected to careful external inspection and the condition of their body orifices was checked. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- 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 per litter (using slicing technique)
- Skeletal examinations: Yes: 2/3 per litter - Statistics:
- t-test was used for comparison between treated and control groups.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Body-weight gain was slightly (non-specific) depressed following the 500 mg/kg bw and 1000 mg/kg bw doses. At the three dose levels, particularly in the intermediate and high-dose group, feed consumption was reduced during the period of treatment. No further signs of intolerability of the compound were noted. The data on the rates of implantation and embryolethality (resorptions) were comparable for all groups.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The average weight of the foetuses was significantly (p<0.01) diminished in the 500 mg/kg bw (-1.7%) and 1000 mg/kg bw (-2.5%) dose group when compared with the control. The mean weight of live fetuses in the control, 150, 500 and 1000 mg/kg bw dose groups were 5.18, 5.16, 5.09 and 5.05 g, respectively. By applying the slicing technique in a few foetuses of the experimental groups minor anomalies were detected which have also occurred in a cumulative of "untreated" controls. Concerning skeletal assessment the only clear-cut deviation from the control group was increase in the number of not yet ossified phalangeal nuclei of the hindlimb following the administration of 1000 mg/kg bw. However, this deviation was not dose-related (Table 1).
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1. Skeletal examinations
Dose groups (mg/kg bw/day) |
No. of skeletons examined |
Phalangeal Nuclei |
|
Fore-limb |
Hind-limb |
||
150 |
193 |
4 (2.1 %) |
52 (26.9%) |
500 |
197 |
6 (3.0%) |
33 (16.8%) |
1000 |
192 |
2 (1.0%) |
74 (38.5%) |
control |
238 |
0 |
36 (15.1%) |
Applicant's summary and conclusion
- Conclusions:
- Based on the results, no teratogenic effects were observed. The NOAEL for teratogenic effects was considered to be >1000 mg/kg bw.
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