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EC number: 813-928-3 | CAS number: 155810-87-0
- 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
- Remarks:
- Screening study on male sexual organ toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Principles of method if other than guideline:
- The aim of this study was to obtain initial information on the effect of the test substance on male sexual organs after repeated oral administration (gavage) to male Wistar rats. The test substance was administered to the animals orally by gavage for a maximum of about 10 weeks.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 2(3H)-Benzofuranone, 5,7-bis(1,1-dimethylethyl)-3-(4-hydroxy-3,5-
- EC Number:
- 813-928-3
- Cas Number:
- 155810-87-0
- Molecular formula:
- C24 H30 O3
- IUPAC Name:
- 2(3H)-Benzofuranone, 5,7-bis(1,1-dimethylethyl)-3-(4-hydroxy-3,5-
- Details on test material:
- Physical state/appearance: Solid/white
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The rat is the preferred animal species for developmental and reproductive toxicity studies according to the various test guidelines. This Wistar rat strain (Crl:Wl(Han)) is selected because extensive historical control data is available for these rats.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: about 7 weeks
- Weight at study initiation:
- Housing: 5/cage
- Diet: Ground Kliba maintenance diet mouse/rat "GLP", Provimi Kliba SA, Kaiseraugst, Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: From delivery to the beginning of administration the animals were accustomed to the environmental conditions and to the
diet.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
For the test substance preparation, the specific amount of test substance was weighed, topped up with cornoil in a graduated flask and intensely mixed with a magnetic stirrer until it is completely dissolved. During administration, the preparations were kept homogeneous with a magnetic stirrer.
VEHICLE
- Concentration in vehicle: 7.5 g/100 ml and 25 g/100 ml
- Amount of vehicle (if gavage): 4 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The stability of the test substance in corn oil in a refrigerator under light exclusion over a period of 7 days had been verified prior to the start of the study.
Concentration analysis:
300 mg/kg: 96.6%
1000 mg/kg: 100.1% - Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
A check for moribund and dead animals was made twice daily from Mondays to Fridays and once daily on Saturdays, Sundays and public holidays. A cageside examination was conducted at least once daily for any signs of morbidity, pertinent behavioral changes and/or signs of overt toxicity. During the administration period all animals were checked daily for any abnormal clinically signs before the administration as well as within 2 hours and within 5 hours after the administration. Abnormalities and changes were documented for each animal.
BODY WEIGHT: Yes
Body weights were determined once a week
FOOD CONSUMPTION
Food consumption was determined once a week.
SPERM AND SPERMATID EXAMINATIONS
After the organ weight determination, the following parameters will be determined in the right testis or right epididymis of all animals sacrificed on schedule:
• Cauda epididymis sperm motility
• Sperm morphology
• Spermatid concentration in the testis
• Sperm concentration in the cauda epididymis
The determination of the cauda epididymis sperm motility and the preparation of the specimens for sperm morphology will be carried out in a randomized sequence. - Sacrifice and pathology:
- One day after the last administration all surviving animals were sacrificed by decapitation under isoflurane anesthesia. The exsanguinated animals were necropsied and assessed by gross pathology, special attention being given to the reproductive organs. Animals which die intercurrently or are sacrificed in a moribund state were necropsied as soon as possible after their death and assessed by gross pathology.
The following weights will be determined in all animals sacrificed on schedule:
1. Anesthetized animals
2. Testes
3. Epididymides
4. Prostate
5. Seminal vesicles including coagulation glands
6. Liver
7. Kidneys
8. Spleen
9. Adrenal glands
10. Pituitary gland
The following organs or tissues will be fixed in 4% formaldehyde solution or in modified Davidson's solution:
1. All gross lesions
2. Testes
3. Epididymides
4. Prostate
5. Seminal vesicles including coagulation glands
6. Liver
7. Kidneys
8. Spleen
9. Adrenal glands
10. Pituitary gland
The epididymides and testes of animals that died or were sacrificed intercurrently will be fixed in 4% buffered formaldehyde solution. The left testis and left epididymis of all animals sacrificed at scheduled dates will be fixed in modified Davidson's solution, whereas the right testis and epididymis will be used for sperm parameters. In case of macroscopic findings in the right testis or right epididymis, this testis as well as
the corresponding epididymis were fixed for histopathological examination and the left testis and epididymis will be used for sperm parameters.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation in treated animals
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 0 mg/kg: cellular debris in left epididymis (2/10), tubular degeneration in left testicle (2/10).
300 mg/kg: cellular debris in left epididymis (2/10), tubular degeneration in left testicle (2/10), tubular vacuolation in left testis (2/10)
1000 mg/kg: no findings - Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effects on sperm parameters
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- Testes and Sperm toxicity
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no effects observed
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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