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Diss Factsheets
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EC number: 907-658-6 | CAS number: -
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to OECD guideline. No data on GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Limit test:
- no
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:
- (1S,2S,4S) 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
- Details on test material:
- Purity >97 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFE
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bush Boake Allen Ltd., London
- Weight at study initiation: 100-120 g (male) and 90-105 g (female)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1ºC
- Humidity (%): 50-60%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 ml total dose/kg/day - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks ( 0, 15, 90 or 270 mg/kg bw/day)
2 to 6 weeks (0, 90 or 270 mg/kg bw/day)v - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 15, 90 or 270 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 15 male and 15 female: 0, 15, 90 or 270 mg/kg bw/day
5 male and 5 female: 0, 90 or 270 mg/kg bw/day - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after sacrifice
URINALYSIS: Yes
- Time schedule for collection of urine: collected during the final week and week 6 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- (No deaths and no abnormalities in behaviour or appearance occurred during the study)
- Mortality:
- no mortality observed
- Description (incidence):
- (No deaths and no abnormalities in behaviour or appearance occurred during the study)
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- (no significant differences between test and control animals)
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- (no significant differences between test and control animals)
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- (no significant differences between test and control animals)
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- (Only in males treated with the highers dose increase of mean water consumption was observed)
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- (no differences between the test and control groups )
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- (The females treated with IBA gave results similar to those of female controls throughout. In males there were no differences between control and IBA-treated rats at week 2 but at week 6 cell excretion was increased in rats receiving 270 mg/kg bw/day )
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- (there was increase of weight of some organs.)
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- (Histological changes associated with IBA treatment were confined to treatment at the 270 mg/kg bw/day level.)
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOEL for Iosbornyl acetate (13 weeks ) was 15 mg/kg bw/day.
- Executive summary:
Repeated dose toxicitystudy (oral route) of Isobornyl acetate was performed according to OECD guideline 408. The substance was dissolved in corn oil and administered daily to rats by stomach tube in doses: 0 (control), 15, 90 or 270 mg/kg body weight/day during 13 weeks. There were no differences between treated and control animals in the rate of body-weight gain, the food intake or the results of haematological investigations. In male rats given 270 mg/kg bw/day there was a decrease in renal concentrating ability, an increase in water intake, exfoliation of renal tubular cells, increased kidney weight and vacuolation of the renal tubular cells. Signs of nephrotoxicity were also seen with daily doses of 90 mg/kg bw/day.
Vacuolation of the epithelium of the intrahepatic bile-duct and increase in liver weights were found at 270 mg/kg bw/day. The caecum were also enlarged at this dosage level.
The no-effect level found was at 15 mg/kg bw/day.
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