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EC number: 204-727-6 | CAS number: 125-12-2
- 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:
- April 22th to May 28th 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- EC Number:
- 204-727-6
- EC Name:
- Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Cas Number:
- 125-12-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): Isobornylacetat-Extra
- Physical state: liquid
- Analytical purity: 93.5 – 95.0 % Isobornylacetat
- Impurities (identity and concentrations): other terpene esters and camphene
- Composition of test material, percentage of components:
94.6 % Isobornylacetat
2.8 % Isofenchylacetat
0.8 % Pseudobornylacetat
0.5 % Fenchylacetat
0.4 % Isoborneol
0.1 % Camphen
- Lot/batch No.: 249/90
- Storage condition of test material: dark, at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoe: WISKf (SPF71)
- Age at study initiation:65-70 days
- Weight at study initiation: 191 + / - 6 g
- Housing: individually in plastic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days prior the test
- Sex: female
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 ° C
- Humidity (%): 49-53%
- Air changes (per hr): 16-20/h
- Photoperiod (hrs dark / hrs light): 12 light hours a day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: the substance was dissolved fresh daily in a concentration of 200 g/l in sesame oil. The applied fluid volume was in all animals 5 ml/kg body weight.
VEHICLE
- Amount of vehicle (if gavage): 5 ml/kg bw dose - Details on mating procedure:
- - Proof of pregnancy: sperm in vaginal smear referred to as day 1 of pregnancy
- Duration of treatment / exposure:
- days 7 to 16 of gravity
- Frequency of treatment:
- once daily, administered within three hours
- Duration of test:
- Sacrifice at day 21 of gravity
- No. of animals per sex per dose:
- 20 mated females: test group
21 mated females: control group - Control animals:
- yes
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: once a week and a day after the last application
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: uterus, ovaries
OTHER:
Macroscopic examination and weighing of the organs: heart, liver, kidneys and spleen - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Skeletal examinations: Yes: half per litter
- Body cross-sections for Wilson, photography: half per litter - Statistics:
- Comparisons between body weights and organ weights in the test and control group were performed with a classical analysis of variance (MANOVA); to evaluate the relative feed intake, a analysis of variance according to Puri & Sen (1985).
Corpora lutea and implantations were performed with the Mantel-Haenszel x2 test (Mantel & Haenszel, 1959), as well as live and dead fetuses and resorptions. Other parameters according to an analysis of variance.
The body cross-sectional study of fetuses and skeletal findings were studied with the Fisher Exact test.
- Historical control data:
- To compare the data with historical controls, normal ranges were calculated for groups.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- 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
All findings did not differ from those of control group out of the spontaneous rate.
Applicant's summary and conclusion
- Conclusions:
- No maternal toxic effects, no embryonic/fetal toxic effects and no teratogenic effect at oral doses of 1000 mg/kg bw/day in rats.
- Executive summary:
Isobornylacetate-extra was tested in a limit test of a group of 20 female Wistar rats from 7 to 16 day of gravity, administered once daily in a dose of 1000 mg / kg bw. As a control, was an equally large group of control animals that received the vehicle without substance addition.On 21 days of gestation were killed the mother animals and examined. Fetuses were morphologically observed for developmental disorders. The morphological examination of fetuses revealed no evidence for embryotoxic and teratogenic effects of the substance. The findings are assigned to the spontaneous rate. Neither maternal nor embryonic/fetal toxicity was found at oral doses of 1000 mg/kg bw/day IBA in rats.An indication of teratogenic effect could not be noticed.
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