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EC number: 241-164-5 | CAS number: 17095-24-8
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- other: Data sharing dispute
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Objective of study:
- absorption
- distribution
- excretion
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: 75/318 EWG, Appendix IV
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 197 to 225 g
- Fasting period before study: -
- Housing: single (excretion/tissues); 2/cage (plasma levels, exhalation)
- Individual metabolism cages: yes (excretion) / no (plasma levels, exhalation)
- Diet: Altromin 1321 ad libitum
- Water: tap ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 27
- Humidity (%): 30 to 55
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): -
IN-LIFE DATES: From: 23. Aug. To: 14. Sep. 1990 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- single dose
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- Doses / Concentrations:
Concentration: 2 mg/g solution
analytically verified - No. of animals per sex per dose / concentration:
- Exhalation: 2
Blood/plasma levels: 5
Excretion/remaining concentration: 5
Excretion i.v.: 3 - Control animals:
- not specified
- Positive control reference chemical:
- not examined
- Details on dosing and sampling:
- - Tissues and body fluids sampled: urine, feces, blood, plasma, exhalate, tissues (spleen, stomach,
intestines, liver, kidneys, gonads, heart, lungs, skeletal muscle, subcutaneous fat, retroperitoneal fat,
brain, eyes)
- Time and frequency of sampling:
- Blood sampling: 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 24, 32, 48, 72, 96, 120, 144, 168 h after test item
administration
- Urine sampling: in polyethylen bottles 0 -2, 2 -4, 4 -8, 8 -24, 24 -48, 48 -72, 72 -96, 96 -120, 120
-144, 144 -168 h after test item administration
- Cage washings: 0-8, 8-24, 24-96, 96-168 h after test item administration
- Feces sampling: in glass vessels: 0 - 24, 24 -48, 48 -72, 72 -96, 96 -120, 120 -144, 144 -168 h
after test item administration
- Organ/tissue sampling: directly after sacrifice - 7 days after test item administration
- Exhaled air: continuous aspiration at 0.2 m³/h
- Method type(s) for detection: Liquid scintillation counting
- Limits of detection and quantification: determination of blank value - Statistics:
- no data
- Preliminary studies:
- NA
- Details on absorption:
- ca. 1 % (estimated from study HOE 98.0388)
- Details on distribution in tissues:
- Kidneys: 0.1228 μg equivalent/g
Spleen: 0.0332 μg equivalent/g
subcutaneous fat: 0.0174 μg equivalent/g
Lungs: 0.013 μg equivalent/g
All other organs: < 0.01 μg equivalent/g
In sum 0.0344% of the administered dose - Observation:
- not determined
- Details on excretion:
- Excretion mainly via feces: 95.58% of the administered dose; t1/2(I): 4.9 h, t1/2(II): 75 h
Renal excretion: 1.22% + 014% (cage washing) of the administered dose; t1/2(I): 5 h, t1/2(II): 71 h
Bi-phasic elimination
no excretion by exhalation - Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: 0.19 μg eq/g
- Test no.:
- #1
- Toxicokinetic parameters:
- Tmax: 6.8 hours
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 22.1 hours
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: AUC: 48: 5.85 μg eq*h/g
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: AUC: oo: 6.66 μg eq*h/g
- Test no.:
- #2
- Toxicokinetic parameters:
- Cmax: Cmax: 0.29 μg eq/g
- Test no.:
- #2
- Toxicokinetic parameters:
- Tmax: Tmax: 6.4 hours
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: half-life 1st: 18.5 hours
- Test no.:
- #2
- Toxicokinetic parameters:
- AUC: AUC: 72: 7.14 μg eq*h/g
- Test no.:
- #2
- Toxicokinetic parameters:
- AUC: AUC: oo: 8.8 μg eq*h/g
- Metabolites identified:
- no
- Details on metabolites:
- see metabolism study DM90/001
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
After oral gavage, the radioactivity was predominantly eliminated via the feces (95.58 ± 1.86 %) within
7 days. The renal (including cage wash) eliminated part was 1.36 ± 0.53 %. Excretion in feces and
urine was biphasic. There was no tendency for the test item or its metabolites to bioaccumulate in
blood or tissues. - Executive summary:
The kinetics of in the naphthalene-part14C-labelled HOE CG 0062 was examined in male rats after
single oral treatment at about 10 mg/kg body weight.
The slow increase of the radioactivity led to concentration maxima of 0.19 and 0.29 μg equivalent/g
after on average 6.8 and 6.4 h in blood and plasma, respectively. The concentration decrease occurred
with biological half times of 22.1 and 18.5 hours in blood and plasma, respectively. The comparable
kinetics in blood and plasma is a hint for the fact that binding of radioactivity to formed blood components
does not occur.
After oral gavage, the radioactivity was predominantly eliminated within 7 days via the feces (95.58
± 1.86%). The renal (including cage wash) eliminated part was 1.36 ± 0.53%. Excretion in feces and
urine was biphasic. For the first rapid phase, half times of 4.9 h (feces) and approx. 5 h (urine) were
calculated or estimated, respectively. In the slow second phase (t½ca. 75 h for feces and 71 h for urine)
only about 1% (feces) and 0.1% (urine) or less were excreted.
At the end of the study, 7 days after oral administration, the highest remaining concentrations were
measured in the kidneys (0.12 μg equivalent/g), followed by spleen (0.03 μg equivalent/g), subcutaneous
fatty tissue (0.02 μg equivalent/g) and lung (0.01 μg equivalent/g). The remaining tissues contained
less than 0.01 μg equivalent/g. Overall, 0.03% of the administered dose was found in the tissues
investigated.The recovery rate was 96.98 ± 1.45% of the administered radioactivity.
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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