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EC number: 202-046-9 | CAS number: 91-17-8
- 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:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of 60 chemicals in a preliminary developmental toxicity test
- Author:
- Hardin BD, Schuler RL, Burg JR, Booth GM, Hazelden KP, MacKenzie KM, Piccirillo VJ, Smith KN.
- Year:
- 1 987
- Bibliographic source:
- Teratogenesis, Carcinogenesis, Mutagenesis 7, 29-48
Materials and methods
- Principles of method if other than guideline:
- Reproduction toxicity test.
Pregnant mice were dosed during mid-pregnancy and were then allowed to deliver litters. Litter size, birth weight, and neonatal growth and survival to postnatal day 3 were recorded as indices of potential developmental toxicity - GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Decahydronaphthalene
- EC Number:
- 202-046-9
- EC Name:
- Decahydronaphthalene
- Cas Number:
- 91-17-8
- Molecular formula:
- C10H18
- IUPAC Name:
- decahydronaphthalene
- Details on test material:
- Decahydronaphthalene, no data on purity or isomer ratio
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species/ Strain: mice, CD-1
- Source: Charles River Breeding Laboratories
- Age: 6-8 weeks
- Food (ad libitum): BP Nutrition Rat Mouse Breeder Diet No. 3, Purina Certified Rodent Chow
No. 5002, Wayne Lab-Blox, or Zeigler Brothers NIH-07 diet
- Water (ad libitum)
- Housing: during dose-range finding group housed (five per cage) throughout treatment, and observation periods, during main study singly housed in solid-bottom boxes. Nesting material (Bed-O-Cobs, Sani-chip, San-i-cel, or sterilized white wood shavings) was changed once weekly, but no bedding change was made later than gd 17 to avoid disturbing mice near parturition.
ENVIRONMENTAL CONDITIONS:
-12 hrs dark/ light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- - gavage, dosing volume of 5 ml/kg body weight
- vehicle: corn oil
- control group with concurrent vehicle
- during dose-range finding: five dose levels using ten virgin female mice per group. Treatments were administered once daily for 8 consecutive days, with a dosing volume determined on the basis of body weights on the first treatment day.
- during main study: 2700 mg/ kg/ day, Treatments in the reproductive phase were administered once daily on gd 6-13, with a dosing volume determined on the basis of pretreatment body weights on gd 6. Experimental blocks consisted of 2-6 chemically treated groups with a concurrent vehicle control. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- no data, time-mated mice were to be shipped on gd 0-2
- Duration of treatment / exposure:
- during dose-range finding: once daily for 8 consecutive days, during main study: administered once daily on gd 6-13,
- Frequency of treatment:
- once daily
- Duration of test:
- until gd 22 in the main study
Doses / concentrations
- Dose / conc.:
- 2 700 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 48
- Control animals:
- other: yes, controls recived corn oil
- Details on study design:
- - All experiments were conducted in two phases: an initial dose-finding study, followed by a reproductive phase which employed a single dose level for the main study. In both pases, treatments were administered by gavage using as dosing volume of 5 ml/kg bw.
- For dose-finding, test item was tested at five dose levels using ten virgin female mice per group. Mice were observed twice daily during treatment, and once daily for 8 days following treatments. Body weights were recorded on the first and last (eighth) day of treatment, and on days 4 and 8 post-treatment. Signs of toxicity were recorded, and dead mice were necropsied to exclude dosing error, eg, instillation into the lungs or perforation of the esophagus, as a cause of death.
- Dose selection rationale: For the reproductive phase (main study), the LDI0 predicted on the basis of dose-finding results was the single dose used.
- Rationale for animal assignment (if not random):
- Other: Treatments in the reproductive phase were administered once daily on gd 6-13, with a dosing volume determined on the basis of pretreatment body weights on gd 6.
Experimental blocks consisted of 2-6 chemically treated groups with a concurrent vehicle control. Mice were observed twice daily during treatment, and once daily on gd 14-17. Body weights were again recorded on gd 17. At the daily observation, signs
of toxicity were recorded. Dead mice were necropsied to exclude dosing error as a cause of death. Beginning on gd 18, mice were observed twice daily for signs of parturition. When delivery was judged to be complete (postnatal day !), the number
of live pups was recorded, and live pups were weighed together as a litter, then returned to the dam. Neither live nor dead pups were systematically examined for malformations.
Two days later (postnatal day 3), live pups were again counted and weighed as a litter, and maternal body weights were recorded. Dams and litters were then discarded. Females that failed to deliver a litter by the presumed gd 22 were killed and uteri were examined.
If there was no gross evidence of a failed pregnancy, uteri were placed in 10% ammonium or sodium sulfide to reveal implantation sites as evidence of early termination of pregnancy.
Examinations
- Maternal examinations:
- Mortality, body weight change, viable litters
- Fetal examinations:
- liveborn per litter, percentage survival, birth weight, weight gain on postnatal day 3
- Statistics:
- Data reported by individual testing laboratories were coded into the Parklawn Computer System. and printouts were reviewed by the contractors to verify the accuracy of the data. The Statistical Analysis System (SAS Institute Inc., Cary. NC) was then used to analyze results of each experimental block. Body weights on gd 6 were analyzed by 2-tail ANOVA to verify that there were no group differences in initial body weight. Mortality (excluding death attributed to dosing error) was contrasted between pregnant and nonpregnant mice by 2-tail Fisher's exact test. Nonpregnant mice, as determined by uterine examination. were excluded from all subsequent analyses. The proponion of pregnant survivors that delivered a viablelitter (at least one liveborn pup) was compared with the concurrent vehicle control by I-tail Fishers exact test. For mice that delivered a viable litter, maternal body weight
change from gd 6 to postnatal day (pd) 3, the number of liveborn pups per litter, percent neonatal survival to pd 3, average pup weight at birth and average pupweight gain by pd 3 were analyzed by pairwise multiple comparisons of control and treated groups using a 2-tail Mann-Whitney U-test. - Historical control data:
- no information
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 7 of 48 pregant mice treated were reported dead
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 7.5 ± 2.6 g significantly higher than control: 6.1 +/-3.7 g (not toxicologically relevant, within limits of historical controls)
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes.
Remark: mortality, body weight gain
Details on maternal toxic effects:
7 of 48 pregant mice treated were reported dead
maternal body weight gain was 7.5 +/- 2.6 g, significantly higher than control: 6.1 +/-3.7 g (not toxicologically relevant, within limits of historical controls)
viable litters: 23/ 24
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 2 700 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- < 2 700 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 700 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- live born/ litter: 9.9 +/- 2.3 (control: 9.4 +/- 2.7)
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- birth weight: 1.6 +/- 0.1 g; weight gain: 1.0 +/- 0.2 g
- Changes in postnatal survival:
- no effects observed
- Description (incidence and severity):
- percentage survival: 100
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 700 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse developmental effects were noted.
- Executive summary:
Pregnant mice were dosed during mid-pregnancy (gestation days 6 -13) with decahydronaphthalene by gavage at a dose level of 2700 mg/kg bw/d and were then allowed to deliver litters. Litter size, birth weight, and neonatal growth and survival to postnatal day 3 were recorded as indices of potential developmental toxicity. Seven of 48 treated dams were reported dead, body weight gain was statistically significant increased as compared to control that received corn oil but within the variation of controls. There were no adverse effects on neonatal parameters, number of liveborn per litter, survival and body weight gain to post natal day 3.
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