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EC number: 272-905-0 | CAS number: 68919-79-9
- 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
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 16, 2015 to March 31, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 423, in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment No 19, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Age at First Dose: At least 6-7 weeks; female animals were non-pregnant and nulliparous
- Animal Health: The health condition of animals was examined by a veterinarian before initiation of the study.
- Housing Condition: The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, males and females separately in a room equipped with central air-conditioning
- Bedding: Lignocel S3/4
- Animals Identification: Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
- Acclimation period: 5 d
- Diet: A laboratory food Altromin was offered in recommended doses each day approximately at the same time after dosing
- Water: Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 55%±10%
- Photoperiod: 12 h light/dark cycle (deviation ± 30 minute).
IN-LIFE DATES: From: March 16, 2015 To: March 31, 2015 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
Lot Number: 04280314
Expiration: 03/2015
Manufacturer: Vulm.sk
Storage: Room temperature (20±5°C)
DOSE PREPARATION
The required amount of the test substance was mixed with vehicle shortly before administration.
DOSE ADMINISTRATION
The test substance was administered in a single dose by gavage using a stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the - Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 6 females
- Details on study design:
- Number of Animals and Dose Level
Available information indicated that test substance is likely to be nontoxic considering to acute toxicity. Therefore, a limit dose of 2,000 mg/kg bw was used as starting dose. Group of 3 female rats were used. Test substance related mortality was not produced during 24 h; group of 3 females and 3 males were tested at the same dose.
Clinical Observation
Animals were observed individually immediately after the administration of the test substance and then 30 min, 1, 2, and 4 h later. Then each animal was inspected for the next 14 d.
Observations included changes in skin and fur, eyes and mucous membranes as well as respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight
Individual weights of animals were determined shortly before the test substance was administered and weekly thereafter. Weight differences after first and second weeks post-application were calculated and recorded.
Necropsy
All test animals were subjected to gross necropsy. Detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities. All gross pathological changes were recorded for each animal. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.
- Body weight:
- The body weights of all animals were increasing during the study. No body weight losses were observed one and two weeks after application.
- Gross pathology:
- All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopically changes were noticed.
- Conclusions:
- The oral LD50 was found to be > 2,000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 423, in compliance with GLP. Groups of six female and three male rats received a single dose of 2,000 mg/kg bw by gavage. No mortality occurred and no symptoms of toxicity or body weight loss were seen during the observation period. Under the study conditions, the oral LD50 was > 2,000 mg/kg bw in rats (Hozova R, 2015).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- High quality
Additional information
A study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 423, in compliance with GLP. Groups of six female and three male rats received a single dose of 2,000 mg/kg bw by gavage. No mortality occurred and no symptoms of toxicity or body weight loss were seen during the observation period. Under the study conditions, the oral LD50 was > 2,000 mg/kg bw in rats (Hozova R, 2015).
Justification for selection of acute toxicity – oral endpoint
High quality study conducted as per internationally accepted Guideline.
Justification for classification or non-classification
Oral route:
Based on the results of an acute oral toxicity study, the test substance does not require classification for this endpoint according to the EU CLP criteria (EC 1272/2008).
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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