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EC number: 202-049-5 | CAS number: 91-20-3
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subchronic
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to EPA and OECD guideline
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA OPP 82-4 (90-Day Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day)
- Deviations:
- no
- Remarks:
- but no recovery groups included
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Naphthalene
- EC Number:
- 202-049-5
- EC Name:
- Naphthalene
- Cas Number:
- 91-20-3
- Molecular formula:
- C10H8
- IUPAC Name:
- naphthalene
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Naphthalene
- Substance type: Aromatic hydrocarbon
- Physical state: Grey-white crystalline solid
- Analytical purity: Assumed to be pure
- Impurities (identity and concentrations): None provided
- Lot/batch No.: LI-1 (LX No: LX158-01)
- Expiration date of the lot/batch: (a) 27 April 1993, (b) 25 June 1993
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- SOURCE:
- Age at study initiation: 8 ½ weeks
- Weight at study initiation: Male 221 – 272g; female 155 – 190g
- Fasting period before study: None
- Housing: Group housed 5/sex/cage
- Diet: ad libitum (while in cages)
- Water: ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 22°C
- Humidity (%): 30 – 67
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12 hr dark / 12 hr light
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- nose only
- Vehicle:
- clean air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION:
-Exposure apparatus: Nose only inhalation chamber (ADG Instruments) with 20 exposure ports and a top section incorporating a tangential air inlet.Each chamber was assembled in 3 sections and formed a 28 cm diameter cylinder with a volume of approximately 50 litres. A separate exposure chamber was used for each group.
- Method of holding animals in test chamber: Molded polycarbonate tubes tapered at one end to allow the nose-only of the rat to protrude from the tapered end of the chamber. The other end was closed by insertion of an expanded plastic bung.
- Source and rate of air: Air was withdrawn from the base of the chamber at a rate of 30 litres/minute. The air was withdrawn by a vacuum pump through filtration media, to remove particulate, and a silica gel to remove excess moisture. The air supply to the chamber was comprised of a carrier (vapour) and a diluent air supply, to a total of 25 litres/minute to allow the exposure chamber to be maintained at a slight negative pressure.
- Method of conditioning air: See above
- System of generating particulates/aerosols: A separate vapour generation system was used for each group. It consisted of a 3-necked round bottom flask containing an aliquot of the test substance. Air was passed through the flask and vapour-laden air passed out through a second neck. The third neck contained a thermometer. At lower concentrations the test atmosphere was generated under ambient temperatures using the carrier airflow to maintain the concentration. At higher concentrations the test substance flask and carrier air was heated in a water bath to assist vaporisation. The vapour-laden air was passed through a clear plastic tube with glass wool (particulate trap) and mixed with diluent air (where applicable) before entering the chamber.
- Temperature, humidity, pressure in air chamber: Temperature 19.7 – 20.1°C; Humidity 45 – 52%; Oxygen concentration 21%
- Air flow rate: 30 litres/minute
- Air change rate: (30 l/min)/50 l; 36/hour
- Method of particle size determination: Not applicable
TEST ATMOSPHERE:
- Brief description of analytical method used: GC analysis of samples reacted with carbon disulfide. Column: 2mm x 1m i.d. glass packed with 10% OV-101 (80 -100 mesh). Column conditions: temperature- injector 200°C, column 120°C, detector 250°C. Gases: helium 30ml/min, hydrogen 33 ml/min, air 300ml/min: Retention time for Naphthalene 1.3 minutes.
- Samples taken from breathing zone: Yes
VEHICLE (if applicable):
- Justification for use and choice of vehicle: Air; Not applicable - Details on mating procedure:
- No mating occured
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples taken at 1, 3 and 5 hours for all treatment groups during each exposure.
Brief description of analytical method used: GC analysis of samples reacted with carbon disulfide. Column: 2mm x 1m i.d. glass packed with 10% OV-101 (80 -100 mesh). Column conditions: temperature- injector 200°C, column 120°C, detector 250°C. Gases: helium 30ml/min, hydrogen 33 ml/min, air 300ml/min: Retention time for Naphthalene 1.3 minutes.
Samples taken from breathing zone: Yes - Duration of treatment / exposure:
- 13 consecutive weeks
- Frequency of treatment:
- Six hours exposure for 5 days a week
- Details on study schedule:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Target 2, 10, 60 ppm: analysed 2, 10, 58 ppm (11, 52, and 304 mg/m3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: 4 week inhalation study
Rationale for animal assignment (if not random): Computer distribution based on body weight
Rationale for selecting satellite groups: None - Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice a day
- Cage side observations checked in table [No. 9.1] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, Weekly
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: Not calculated but data present
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to allocation and during week 13
- Dose groups that were examined: All
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Week 13
- Anaesthetic used for blood collection: Yes, light ether anaesthesia
- Animals fasted: Yes
- How many animals: All
- Parameters checked in table [No. 9.7] were examined. PCV, Hb, RBC, MCHC, MCV, WBC, Diff, Plts, TT, Retic, and P, H, A, and R.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Week 13
- Animals fasted: Yes
- How many animals: All
- Parameters checked in table [No. 9.8] were examined. CPK, glucose, GPT, GOT, g-GT, AP, total protein, Alb, Glob, Urea Nitr, total bilirubin, creatine, NA, K, Ca, P, Cl, and Chol.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- No litters produced
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
- Postmortem examinations (offspring):
- No offspring produced
- Statistics:
- Bartlett’s for homogeneity, if heterogeneous then Kruskal-Wallis. Analysis of variance (Student’s t test) for dose response.
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 3 deaths but not related to treatment. Increase in brown staining of fur but not considered toxicologically significant.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight gain at 58 ppm in males and females. Reduced body weight gain at 10 ppm in males.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced body weight gain at 58 ppm in males and females. Reduced body weight gain at 10 ppm in males.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- See "details on results".
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Degenerative changes in the olfactory epithelium including slight disorganisation, occasional degenerated cells, atrophy and erosion. The changes were more severe at 10 and 58 ppm and generally less severe at mild grades of individual lesions at 2 ppm. Subepithelial effects were observed in Bowman’s glands.
Proliferative lesions of the olfactory epithelium at the 58 ppm dose included hyperplasia of basal cells, rosette formation, hyperplasia (with loss of olfactory features), and in a single case early squamous metaplasia. The dose response of the proliferative lesions was not as obvious as of the degenerative changes due to the fact that continuous degenerative damage at the 60 ppm level resulted in increased cell death, thus restricting the proliferative (reparative) changes.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- (highest exposure level tested)
- Effect level:
- 306 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Histopathology of reproductive organs: testes, epididymis, ovaries, uterus, oviduct along with reproductive organ weights (testes with epididymides, prostate, ovaries)
- Dose descriptor:
- LOAEC
- Effect level:
- 0.011 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Histopathology: local degenerative effects in the olfactory region - atrophy, hyperplasia of epithelium, loss of Bowman´s glands
- Dose descriptor:
- LOAEC
- Effect level:
- 2 ppm (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see histopathologic effects above
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1: Macroscopic pathology incidence summary – terminal kill (from Report, Table 8)
(Note: Only organs showing any anomalies are included)
Females |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Animals on study |
10 |
10 |
10 |
10 |
Animals completed |
10 |
9 |
10 |
10 |
Uterus Fluid distension |
1 |
3 |
1 |
2 |
Males |
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Animals on study |
10 |
10 |
10 |
10 |
Animals completed |
9 |
9 |
10 |
10 |
Epididymides Yellow swellings |
0 |
0 |
0 |
1 |
Table 2: Microscopic pathology incidence summary (from Report, Table 10)
(Note: Only organs showing any anomalies are included)
|
Group 1 |
Group 2 |
Group 3 |
Group 4 |
Animals on study |
10 |
10 |
10 |
10 |
Animals completed |
10 |
10 |
10 |
10 |
Uterus |
|
|
|
|
Examined |
10 |
4 |
1 |
10 |
No abnormalities detected |
9 |
0 |
0 |
8 |
Luminal dilatation (total) |
1 |
4 |
1 |
2 |
Moderate |
1 |
3 |
1 |
2 |
Marked |
0 |
1 |
0 |
0 |
Ovaries |
|
|
|
|
Examined |
10 |
0 |
0 |
10 |
No abnormalities detected |
10 |
0 |
0 |
8 |
Cystic corpus luteum |
0 |
0 |
0 |
1 |
Cystic follicles |
0 |
0 |
0 |
1 |
Epididymides |
|
|
|
|
Examined |
10 |
0 |
0 |
10 |
No abnormalities detected |
10 |
0 |
0 |
9 |
Sperm granuloma |
0 |
0 |
0 |
1 |
Testes |
|
|
|
|
Examined |
10 |
0 |
0 |
10 |
No abnormalities detected |
10 |
0 |
0 |
8 |
Atrophy (total) |
0 |
0 |
0 |
1 |
Minimal |
0 |
0 |
0 |
1 |
Tubular atrophy (total) |
0 |
0 |
0 |
1 |
Minimal |
0 |
0 |
0 |
1 |
Applicant's summary and conclusion
- Conclusions:
- Conclusion: Regardless of the route of exposure, no effect in the rat on reproductive organs was found in sub-chronic studies.
- Executive summary:
Ten male and ten female CRL:CD®(SD)BR Sprague-Dawley rats were exposed nose-only to 0, 2, 10, and 60 (58 measured) ppm for six hours a day for five days a week for 13 consecutive weeks. Detailed macroscopic examinations of each rat was performed and organ weights of ovaries, prostate, testes with epididymides were controlled. Microscopic examination of testes plus epididymides, prostate, seminal vesicles, uterus (corpus plus cervix), oviduct and ovaries was performed. No treatment-related effects or alteration in any reproductive organ was found (testes, epididymides, uterus, cervix, ovaries, and oviducts) after exposure to naphthalene by inhalation.
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