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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-09-16 to 1996-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- subchronic exposure
- Principles of method if other than guideline:
- NTP mouse peripheral blood micronucleus test protocol
MacGregor, J. T., Wehr, C. M., Henika, P. R., Shelby, M. D.(1990) Fund. Appl. Toxicol. 14, 513. - GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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, purity > 99 %
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: Taconic Laboratory Animals and Services, Germantown (NY, USA)
- Age: 6 weeks at study initiation
- Weight at study initiation: males mean 21.9 g, females mean 19.6 g
- Number of animals: 10 males + 10 females per exposure concentration
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- Vehicle: clean air
- Details on exposure:
- ADMINISTRATION:
- Concentration in vehicle: established within 12 minutes, monitored every 24 minutes At 72 +- 3 °F (22.2 °C) the ppm concentrations
correspond to: 143, 285, 570, 1141, 2282 mg/m3
- Frequency of treatment: 6 hours (+ 12 minutes concentration buildup)/day, 5 days/week
- Control groups and treatment: concurrent vehicle
EXAMINATIONS:
CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: observed twice daily
- Mortality: observed twice daily
- Clinical findings: weekly
- Body weight: initially + weekly + end of study
- Hematology: Blood sampling at end of study. Determination of hematocrit; packed red cell volume; hemoglobin; erthrocyte, reticulocyte, nucleated erythrocyte, and platelet counts; mean cell volume; mean cell hemoglobin; mean cell hemoglobin concentration; and leukocyte count and
differentials.
- Biochemistry: None
- Urinalysis: Sampling during week 12. Determination of creatinine, glucose, glucose/creatinine ratio, protein, protein/creatinine ratio, alkaline
phosphatase, alkaline phosphatase/creatinine ratio, alkaline aminotransferase, aspartate aminotransferase, aspartate aminotransferase/creatinine ratio, lactate dehydrogenase, lactate dehydrogenase/creatinine ratio, gamma-glutamyltransferase, gamma-glutamyltransferase/creatinine ratio, N-acetyl-beta-D-glucosaminidase, N-acetyl-beta- D-glucosaminidase/creatinine ratio, volume, and specific gravity.
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Weights: heart, right kidney, liver, lung, right testis, thymus
- Macroscopic: yes, no details reported
- Microscopic: 0 and 400 ppm animals: gross lesions, adrenal gland, bone with marrow, brain, clitoral gland, esophagus, gall bladder, heart, large
intestine (cecum, colon, rectum), small intestine (duodenum, jejunum, ileum), kidney, larynx, liver, lung, lymph nodes (mandibular, mesenteric,
bronchial, and mediastinal), mammary gland (females only), nose, ovary, pancreas, parathyroid gland, pituitary gland, preputial gland, prostate
gland, salivary gland, skin, spleen, stomach (forestomach and glandular), testis with epididymis and seminal vesicle, thymus, thyroid gland,
trachea, urinary bladder, and uterus.
- Sampling times and number of samples: end of 3-month toxicity study, peripheral blood samples 2000 NCEs (normochromatic erythrocytes)
per animal were analysed for micronuclei in up to 10 animals per exposure group. 1000 erythrocytes were counted to determine the percentage
of polychromatic (immature) erythrocytes (PCEs) among the total erythrocyte population.
- Criteria for evaluating results:
(1) one-tailed Cochran-Armitage trend test, followed by pairwise comparisons between each exposed group and the control, for determination
of concentration-response relationship
(2) adjustment in case of excess binomial variation (binomial dispersion test)
(3a) P <= 0.025 in trend test OR
(3b) single group with P <= 0.025/number of exposed groups
(4) expert judgment by scientific staff
- Criteria for selection of M.T.D.: Low mortality and low impairment of body weight development in preceding two-week study - Duration of treatment / exposure:
- 14 weeks; 1 additional day before end of study
- Frequency of treatment:
- 6 hours (+ 12 minutes concentration buildup)/day, 5 days/week
- Post exposure period:
- Post-exposure period: none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
25, 50, 100, 200, 400 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
Examinations
- Evaluation criteria:
- In the micronucleus test, an individual trial is considered positive if the trend test P value is less than or equal to 0.025 or
if the P value for any single exposed group is less than or equal to 0.025 divided by the number of exposed groups.
A final call of positive for micronucleus induction is preferably based on reproducibly positive trials. - Statistics:
- The frequency of micronucleated cells among NCEs was analyzed by a statistical software package that tested for increasing trend over exposure groups with a one-tailed Cochran- Armitage trend test, followed by pairwise comparisons between each exposed group and the chamber control group
(ILS, 1990). In the presence of excess binomial variation, as detected by a binomial dispersion test, the binomial variance of the Cochran-Armitage test was adjusted upward in proportion to the excess variation.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Additional information on results:
- MORTALITY: All mice survived to the end of the study.
CLINICAL SIGNS: There were no clinical findings related to exposure.
NECROPSY FINDINGS: see subchronic toxicity study
BODY WEIGHT CHANGES: see subchronic toxicity study
GENOTOXIC EFFECTS:
- males: small but statistically significant (P=0.001) increase in frequency of micronucleated NCEs with exposure concentration
- female: no induction of micronuclei (P=0.917)
- both: slight increase over exposure range in percentage of PCEs, however, all values were within the normal range
NOAEL (NOEL) (C) / LOAEL (LOEL) (C): see subchronic toxicity study
Any other information on results incl. tables
EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO:
--------------------------------------------------------
Treatment Mice scored Sex % Micron. in PCE PCEs (%)
--------------------------------------------------------
0 ppm 10 m 5.5 +/- 1.6 1.8
25 ppm 10 m 4.5 +/- 1.6 1.8
50 ppm 10 m 10.0 +/- 1.5 2.0
100 ppm 10 m 10.0 +/- 2.2 1.9
200 ppm 10 m 12.5 +/- 2.0 1.9
400 ppm 9 m 13.3 +/- 2.0 2.6
--------------------------------------------------------
0 ppm 9 f 6.7 +/- 2.0 1.6
25 ppm 10 f 5.0 +/- 1.1 1.8
50 ppm 10 f 7.0 +/- 1.9 1.6
100 ppm 10 f 3.5 +/- 1.3 1.5
200 ppm 10 f 3.0 +/- 0.8 2.0
400 ppm 10 f 4.0 +/- 1.2 2.0
--------------------------------------------------------
GENOTOXIC EFFECTS:
- males: small but statistically significant (P=0.001) increase in frequency of micronucleated NCEs with exposure concentration
- female: no induction of micronuclei (P=0.917)
- both: slight increase over exposure range in percentage of PCEs, however, all values were within the normal range
NOAEL (NOEL) (C) / LOAEL (LOEL) (C): see subchronic toxicity study
Applicant's summary and conclusion
- Conclusions:
- No effects were noted in females, a slight statistically significant increase in micronucleated normochromatic erythrocytes was observed in males but the values were within the normal range.
- Executive summary:
As part of the repeated dose study, following inhalation exposure to decahydronaphthalene for 5 days per week, 4 hours per day for a period of 3 months blood smears from 10 male and ten female mice were obtained. Dose levels were 0, 25, 50, 100, 200, 400. A slight but statistically significant increase in micronucleated normochromatic erythrocytes was observed in males ppm. However the values were within the normal range. No effects were noted in female mice.
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