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EC number: 212-661-4 | CAS number: 840-65-3
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- no
- Principles of method if other than guideline:
- NDC was administered as a particulate aerosol by inhalation at target concentrations of 0, 1.0, 5.0, and 10.0 mg/m3 to four groups of 10 male and 10 female Sprague-Dawley rats each. The rats were exposed 6 hours per day, 5 days per week for four weeks.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl naphthalene-2,6-dicarboxylate
- EC Number:
- 212-661-4
- EC Name:
- Dimethyl naphthalene-2,6-dicarboxylate
- Cas Number:
- 840-65-3
- Molecular formula:
- C14H12O4
- IUPAC Name:
- 2,6-dimethyl naphthalene-2,6-dicarboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI
- Age at study initiation: approximately 6 weeks of age
- Housing: The rats were individually housed in stainless steel cages measuring 15.5 x 17.0 x 15.8 cm during the 4-week quarantine period. The rats were confined in inhalation cages measuring 13.0 x 20.0 x 27.5 cm during the exposure phase. The cages were suspended over excrement pans. The pans were fitted with deotized cage boards, except during the exposure.
- Diet (e.g. ad libitum): Purina Rodent Chow 5001 supplied from a reverse-osmosis (RO) purifier by an automatic watering system was provided ad Iibitum, except during the inhalation exposures.
- Water (e.g. ad libitum): Water supplied from a reverse-osmosis (RO) purifier by an automatic watering system was provided ad Iibitum, except during the inhalation exposures.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 22°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for 12 hours followed by 12 hours of darkness.
IN-LIFE DATES: From: 24 May 1988 To: 22 June 1988
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: MMAD (mean of 4 samples): Low Exposure: 5.54 ± 0.174; Medium Exposure: 5.05 ± 0.488; High Exposure: 5.56 ± 0.495
Min/Max: Low Exposure (5.28/5.66) ; Medium Exposure (4.57/5.73); High Exposure (5.11/6.19) - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: The generator was a dry materials feeder (Model 310, AccuRate, Whitewater, WI).
- Air flow rate: Chamber airflow in the 2-m3 chambers varied between 300 and 370 L/min, depending on the designated exposure concentration.
- Method of particle size determination: The particle size of the aerosols in each exposure chamber was determined weekly using an Andersen Cascade Impactor.
- Treatment of exhaust air: The chamber exhaust air was drawn through a filtering system before being discharged to the outside environment.
TEST ATMOSPHERE
- Brief description of analytical method used: Test article aerosol concentrations were determined both gravimetrically and spectrophotometrically.
Test article exposure concentrations were also monitored weekly using a Perkin-Elmer Lambda 5 UVIVIS Spectrophotometer operated at 334.0 nm. Sampling filters were extracted with 6 ml of HPLC/Spectro Grade Methanol and the optical density of the extract determined.
- Samples taken from breathing zone: yes
VEHICLE (if applicable)
- Concentration of test material in vehicle: 1.0, 5.0 and 10.0 mg/m3
No additional data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dimethyl-2,6-Naphthalene Dicarboxylate aerosol concentrations were determined both gravimetrically and spectrophotometrically. Samples were collected by drawing a given volume of test atmosphere (i.e. approximately 100-200, 250-350 and 800-1000 liters for the high, medium, and low concentration chambers, respectively, and 800-1000 liters for the filtered air control chamber) across an open-faced filter.
Dimethyl-2,6-Naphthalene Dicarboxylate exposure concentrations were also monitored weekly using a Perkin-Elmer Lambda 5 UVIVIS Spectrophotometer operated at 334.0 nm. Sampling filters were extracted with 6 mL of HPLC/Spectro Grade Methanol and the optical density of the extract determined. - Duration of treatment / exposure:
- The duration of the exposures was 6 hours per day, 5 days per week, for a total of 20 exposures within a 28-day period.
- Frequency of treatment:
- 6 hours per day, 5 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.0, 5.0 and 10.0 mg/m3
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
099, 4.65 and 10.02 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 rat/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- None stated
- Positive control:
- None stated
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The rats were observed once daily for morbidity and mortality during the quarantine period. Following treatment initiation, all rats were observed at least once daily, 7 days/week.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: A complete physical examination was performed once prior to study initiation. Clinical observations were performed daily on weekdays during the exposure phase of the study.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were measured at the initiation of the study, weekly during the exposure phase of the study, and at the termination of the study immediately prior to sacrifice.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
CLINICAL CHEMISTRY: Yes
- Animals fasted: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
No additional data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Necropsies were performed on all rats and the following tissues were collected and fixed in 10% neutral buffered formalin: adrenals, brain, epididymides, eyes, esophagus, femur and bone marrow (smear), gonads, heart, duodenum, Jejunum, Ileum, cecum, colon, kidneys, liver, lungs, lymph nodes (mandibular, respiratory, and mesenteric), mammary gland, nasal turbinates, pancreas, parathyroids, pituitary, prostate and seminal vesicles, salivary glands, sciatic nerve, skeletal muscle, skin, spinal cord, spleen, stomach, thymus, thyroids, tongue, trachea, urinary bladder, uterus, ear with attached tag
HISTOPATHOLOGY: Yes. Any tissue masses or suspect lesions and the lymph nodes which drain the region of the mass or lesion. - Other examinations:
- None stated
- Statistics:
- Means and standard deviations (SD) were calculated for all quantitative parameters.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
The Incidences of salivation and redness around the nose were slightly increased in the Dimethyl-2,6-Naphthalene Dicarboxylate-exposed groups compared to the controls. No rats died during the study.
BODY WEIGHT AND WEIGHT GAIN
There were no statistically significant effects of treatment on body weight or body weight gain during the study.
HAEMATOLOGY
There were no statistically significant effects of treatment on hematology.
CLINICAL CHEMISTRY
There were no statistically significant effects of treatment on the clinical chemistry.
ORGAN WEIGHTS
There were no statistically significant effects of treatment on absolute or relative organ weights or lung volumes.
GROSS PATHOLOGY
Prominent signs observed at necropsy Included lung foci and enlarged, focally reddened mandibular lymph nodes. However, there was no difference in Incidence of these observations between the exposed and the control groups so they were not considered to be treatment-related. Other observations were of a minor, incidental nature.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment-related microscopic lesions was observed in the nasal turbinates, trachea or lungs of any of the rats exposed to Dimethyl-2,6-Naphthalene Dicarboxylate. The most common microscopic lesions seen included lymphoid and plasma cell hyperplasla in the mandibular lymph nodes, but these were of similar incidence among the exposed and control rats, so that the lesions were not considered to be treatment-related. Other lesions in the exposed rats were minor and of an Incidental nature, unrelated to treatment.
No additional data
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 10.02 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In an OECD 412 28-day repeated dose inhalation toxicity study in Sprague-Dawley male and female rats, conducted according to GLP, the NOAEC of NDC is 10.02 mg/m3.
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