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EC number: 201-487-4 | CAS number: 83-56-7
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only as secondary citation available: guideline study and GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 4-week recovery period
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Naphthalene-1,5-diol
- EC Number:
- 201-487-4
- EC Name:
- Naphthalene-1,5-diol
- Cas Number:
- 83-56-7
- Molecular formula:
- C10H8O2
- IUPAC Name:
- naphthalene-1,5-diol
- Test material form:
- other: solid
- Details on test material:
- content: >99.9 % (HPLC)
batch no. 820211/01
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no details
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Wistar rats were treated with 1,5-naphthalenediol for at least 90 days by oral gavage at dose levels up to 300 mg/kg bw/day, followed by a 28-day treatment-free recovery period.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100, 300 mg/kg bw (in propylene glycol)
Basis:
actual ingested
- No. of animals per sex per dose:
- 12 animals per sex and dose, 5 per sex in recovery groups
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Wistar rats were treated with 1,5-naphthalenediol for at least 90 days by oral gavage at dose levels up to 300 mg/kg bw/day, followed by a 28-day treatment-free recovery period.
Mortality and viability were checked at least twice daily.
Clinical observations were made in all animals once daily.
During week 12-13 of treatment functional observation tests were performed including hearing ability, pupillary, static righting and grip strength reflex test and motor activity test
Ophthalmoscopic examinations were conducted at pre-test with all animals and at week 13 with controls and the 300 mg/kg dose group.
Body weight and food consumption were monitored weekly.
blood samples were collected for clinical laboratory investigations immediately prior to scheduled post mortem examination and the common parameters were determined. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Mortality and viability were checked at least twice daily.
Clinical observations were made in all animals once daily.
During week 12-13 of treatment functional observation tests were performed including hearing ability, pupillary, static righting and grip strength reflex test and motor activity test
Ophthalmoscopic examinations were conducted at pre-test with all animals and at week 13 with controls and the 300 mg/kg dose group.
Body weight and food consumption were monitored weekly.
blood samples were collected for clinical laboratory investigations immediately prior to scheduled post mortem examination and the common parameters were determined. - Sacrifice and pathology:
- at the end of the treatment animals of the main stud groups were sacrificed and examined for organ weight gain and pathological anatomical and microscopical changes in the organs.
4 weeks later the animals of the recovery groups were examined - Other examinations:
- no data
- Statistics:
- yes, but methods were not reported.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two males and three females at 300 mg/kg bw died during the treatment phase. Misgavage
was considered the cause of death for one high dose male based on microscopic
assessment and the other high dose male died during blood sampling.
Purple discolouration of the urine was noted in all treatment groups, which resolved immediately after
discontinuation of treatment. This effect was probably caused by the test substance and/or
a test substance metabolite and was not regarded as adverse.
BODY WEIGHT AND WEIGHT GAIN
Body weights and body weight gain of treated animals remained in the same range as
controls over the study period.
FOOD CONSUMPTION AND COMPOUND INTAKE
Food consumption before or after allowance for body weight
was similar between treated and control animals throughout the study period
OPHTHALMOSCOPIC EXAMINATION
There were no ophthalmology findings at pre-test and in week 13.
HAEMATOLOGY and CLINICAL CHEMISTRY
Haematological parameters of treated rats were considered not to have been affected by
treatment. All statistically significant deviations from control mean showed no relationship
to dose and were considered to be incidental in nature. The following statistically significant
deviations in clinical biochemistry parameters that distinguished treated animals from
control animals were considered to be related to treatment:
- increased bilirubin levels in females at 100 mg/kg bw/day and in males and females at
300 mg/kg bw/day
- reduced urea levels in males at 100 and 300 mg/kg bw/day
- increased glucose levels in males and females at 300 mg/kg bw/day
- increased potassium levels in males at 300 mg/kg bw/day
- increased total protein and albumin levels in females at 300 mg/kg bw/day
- reduced aspartate aminotransferase activity in females at 300 mg/kg bw/day
These changes had resolved at the end of the recovery period, whilst increased inorganic
phosphate levels were recorded for high dose females.
URINALYSIS
no data
NEUROBEHAVIOUR
Hearing ability, pupillary reflex, static righting reflex and grip strength were normal in all
animals. Variations were noted in motor activity between treated and control animals but
occurred in the absence of a dose-related response and supportive clinical signs. Therefore,
they were considered to be of no toxicological relevance.
ORGAN WEIGHTS
At the end of treatment, increased absolute kidney weights and kidney to body weight
ratios were measured for high dose males. In addition, absolute liver weights were
increased in high dose females, while liver to body weight ratios were increased in high dose
males and females. These deviations had resolved at the end of the recovery phase.
HISTOPATHOLOGY: NON-NEOPLASTIC
The following microscopic findings were noted at the end of treatment:
- brown/black tubular pigment in the kidneys (minimal to moderate degree) in 11/12
males and 8/11 females at 300 mg/kg bw/day and in 5/12 males at 100 mg/kg
bw/day
- increased severity of hyaline casts was seen in 6/12 males and 2/11 females at 300
mg/kg bw/day and in 2/12 males and 1/12 females at 100 mg/kg bw/day
- increased severity (moderate) of corticomedullary basophilia in 5/12 males at 300
mg/kg/day
- hyperplasia of the squamous epithelium of the limiting ridge in the stomach (minimal
to moderate degree) in 11/12 males and 6/11 females at 300 mg/kg bw/day and in
3/12 males and 3/12 females at 100 mg/kg bw/day.
Following the recovery period slight degree of brown/black tubular pigment in the kidneys
was recorded in 2/5 males at 300 mg/kg bw/day. At 300 mg/kg bw/day one male had
corticomedullary basophilia and slight squamous hyperplasia was recorded in 2/5 females
after the recovery period.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: due to the effects on kidneys and the forestomach
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
According to OECD TG 408 and GLP male and female rats received orally by gavage 1,5 -naphthalenediol for at least 90 consecutive days at doses of 0 (polyehtylene glycol) , 50, 100 and 300 mg/kg bw/day, followed by a 28 -day recovery period. Due to the effects on kidneys (brown-black tubular pigment, increased severity of hyaline casts. corticomedullary basophilia) and forestomach (hyperplasia of the squamous epithelium) a NOAEL of 50 mg/kg bw/day was established.
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