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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 414 (Prenatal Developmental Toxicity Study)
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: 96.8 % (HPLC)
batch: Ro 576
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- no details available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% corboxymethylcellulose wtih 0.5 % cremophor in water
- Details on exposure:
- 1,5-Dihydroxynaphthalene was administered to pregnant rats orally by gavage once daily
from day 6 to day 15 post coitum to the four dose groups 0, 20, 60 and 360 mg/kg bw/day.
Each group consisted of 30 rats. Control animals were dosed with the vehicle alone.
Females were sacrificed on day 20 post coitum and the foetuses were removed by
Caesarean section. The examination of the dams and foetuses was performed in accordance
with international recommendations - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- day 6 to day 15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- up to day 20 post coitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 60 and 360 mg/kg bw/day.
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 pregnant females per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 1,5-Dihydroxynaphthalene was administered to pregnant rats orally by gavage once daily
from day 6 to day 15 post coitum to the four dose groups 0, 20, 60 and 360 mg/kg bw/day.
Each group consisted of 30 rats. Control animals were dosed with the vehicle alone.
Females were sacrificed on day 20 post coitum and the foetuses were removed by
Caesarean section. The examination of the dams and foetuses was performed in accordance
with international recommendations
Examinations
- Maternal examinations:
- The examination of the dams and foetuses was performed in accordance
with international recommendations - Ovaries and uterine content:
- The examination of the dams and foetuses was performed in accordance
with international recommendations - Fetal examinations:
- The examination of the dams and foetuses was performed in accordance
with international recommendations - Statistics:
- no data
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The dams tolerated the applied dose of up to 360 mg/kg bw without lethality or symptoms of cumulative intoxication.
But , the corrected mean body weight gain of the high dose group was significantly decreased compared to the control animals.
There were no treatment related effects in the gestation data.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 360 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The examined foetuses showed no treatment related malformations. the skeletal ossification in all groups was considered to be within normal range.
the testsubstance does not reveal embryotoxic or teratogenic potential at dose levels up to 360 mg/kg bw(day
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the condition of this test. 1,5-naphthalenediol does not cause developmental toxicity up to and including the highest test dose of 360 mg/kg bw despite maternal toxicity at 360 mg/kg bw/day.
- Executive summary:
According to OECD TG 414 1,5-Dihydroxynaphthalene was administered to pregnant rats orally by gavage once daily from day 6 to day 15 post coitum to the four dose groups 0, 20, 60 and 360 mg/kg bw/day. Each group consisted of 30 rats. Control animals were dosed with the vehicle alone. Females were sacrificed on day 20 post coitum and the foetuses were removed by Caesarean section. The examination of the dams and foetuses was performed in accordance with international recommendations. based on significantly decreased body weight gain at the highest test dose the NOAEL of maternal toxicity was considered 60 mg/kg bw/day. The NOAEL of embryo/fetotoxicity and teratogenicity was 360 mg/kg bw/day, the highest applied dose.
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