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EC number: 266-100-3 | CAS number: 66068-84-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- The Teratogenic Effects of the test chemical on the ICR Mice.
- Author:
- RD Lyng
- Year:
- 1 981
- Bibliographic source:
- Indiana Univ-Purdue Univ At Fort Wayne, 31 Mar 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- The Teratogenic Effects of the test chemical on the ICR Mice
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Fuel JP-10 ((3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene)
- Cas Number:
- 2825-82-3
- Molecular formula:
- C10H16
- IUPAC Name:
- Fuel JP-10 ((3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene)
- Details on test material:
- - Name of test material (as cited in study report): Fuel JP-10 ((3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene)
- Molecular formula (if other than submission substance): C10H16
- Molecular weight (if other than submission substance): 136.2364 g/mole
- Substance type: Organic
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on test animals or test system and environmental conditions:
- - Source: Harlan Industries.
- Age at study initiation: (P) x wks; (F1) x wks: not specified
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g: not specified
- Fasting period before study: not specified
- Housing: Animals were housed in plastic cages on wood chip
Bedding. Pregnant females were moved to wire bottomed cages.
- Diet (e.g. ad libitum): Purina Mouse Chow, ad libitum
- Water (e.g. ad libitum): Water , ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24 °C
- Humidity (%):not specified
- Air changes (per hr):not specified
- Photoperiod (hrs dark / hrs light): 12 hour light cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- soya oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:The test chemical diluted with soybean oil at doses of 0, 188, 376, 564 and 752 mg/kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency):not specified
- Mixing appropriate amounts with (Type of food): not specified
- Storage temperature of food:not specified
VEHICLE
- Justification for use and choice of vehicle (if other than water): soybean oil
- Concentration in vehicle: 0, 188, 376, 564 and 752 mg/kg/day
- Amount of vehicle (if gavage): not specified
- Lot/batch no. (if required): not specified
- Purity:not specified - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: Four to five females were kept with each male.
- Length of cohabitation: not specified
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy The day that a vaginal plug was found was designated as day zero of pregnancy. - Duration of treatment / exposure:
- 4 days (6, 7, 8 and 9 of gestation)
- Frequency of treatment:
- Daily
- Duration of test:
- 17 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 188 mg/kg bw/day
- Dose / conc.:
- 376 mg/kg bw/day
- Dose / conc.:
- 564 mg/kg bw/day
- Dose / conc.:
- 752 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 46
0 mg/kg/day: 8 female
188 mg/kg/day: 9 female
376 mg/kg/day: 9 female
564 mg/kg/day: 9 female
752 mg/kg/day: 11 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
Examinations
- Maternal examinations:
- Body weight were examined.
- Ovaries and uterine content:
- Resorptions and Implants were examined.
- Fetal examinations:
- Viable fetuses, Number and position of each fetus, Number of litters and Body weight and Gross pathology, visceral and skeletal abnormalities were examined.
- Statistics:
- Using the methods from Olson and Back (1978) and Wilson and Warkany (1965), the number and position of each fetus was recorded, weighed and examined for abnormalities.
The Students T test was used to test for statistical significance
between mean values and the Fisher exact test was used to test for significant differences in frequency of resorption and skeletal and soft tissue abnormalities using the litter as the experimental unit. - Indices:
- Number and position of each fetus, Number of litters with resorptions and weigh were observed.
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- When treated with 188, 376 and 752 mg/kg bw, increase in body weight gain were observed in the females mice as compared to control and 569 mg/kg bw teated mice.
The increased maternal weight in the 188 and 376 mg/kg is apparently due to increased fetal weight and the increased maternal weight gain in the 752 mg/kg group is due to slightly larger average litter size. - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- No significant effect on mean implants/female were observed as compared to control.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- No effect on frequency of resorptions of treated female mice were observed as compared to control.
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 752 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- early or late resorptions
- maternal abnormalities
- total litter losses by resorption
- other: No effect observed
- Remarks on result:
- other: No toxic effects were observed
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- When treated with 188 and 376 mg/kg bw, increase in mean fetal weights were observed as compared to control and 569 and 752 mg/kg bw treated mice.
The increased fetal weight in the mouse is not easily explained particularly when no such increase occurred in the groups receiving 569 and 752 mg/kg.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- No effect on viability of pups were observed as compared to control.
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- No external abnormalities were observed in any as compared to control.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No Skeletal findings were observed in any as compared to control.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No Soft Tissue were observed in any as compared to control.
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 752 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
- other: No effect observed
- Remarks on result:
- other: No effects on developmental parameters were observed
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 752 mg/kg/day for P and F1 generation when ICR female mice treated with test chemical orally by gavage for 4 days (6, 7, 8 and 9 of gestation).
- Executive summary:
In aTeratogenicity study, ICR female mice were treated with test chemical in the concentration of 0, 188, 376, 569 and 752 mg/kg/day orally by gavage in Soybean oil for 4 days (6, 7, 8 and 9 of gestation). Increase in body weight gain were observed in the females mice at 188, 376 and 752 mg/kg bw as compared to control and 569 mg/kg bw treated mice.The increased maternal weight in the188 and 376 mg/kg is apparently due to increased fetal weight and the increased maternal weight gain in the 752 mg/kg group is due to slightly larger average litter size. Similarly, No significant effect on mean implants/female, mean resorptions/litter and frequency of resorptions of treated female mice were observed as compared to control. In addition, No developmental effect such as viability of pups were observed as compared to control. Increase in mean fetal weights were observed in male and female pups at 188 and 376 mg/kg bw as compared to control and 569 and 752 mg/kg bw treated mice.The increased fetal weight in the mouse is not easily explained particularly when no such increase occurred in the groups receiving 569 and 752 mg/kg. No external abnormalities, Soft Tissue and or Skeletal findings were observed in any pup as compared to control. Therefore, NOAEL was considered to be 752 mg/kg/day for P and F1 generation when ICR female mice treated with test chemical orally by gavage for 4 days (6, 7, 8 and 9 of gestation).
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