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EC number: - | CAS number: -
- 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
Acute toxicity: oral gavage, Sprague-Dawley rat m/f, 5/sex/dose, 2000, 2800, or 3920 mg/kg: LD50 > 2000 mg/kg (OECD 401, GLP)
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:
- 1994-12-06 - 1995-04-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- by Umweltministerium Baden-Württemberg
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna, Suddeutsche Versuchstierfarm, Oberer Bann 37, D-78532 Tuttlingen
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 202 - 245g (females), 207 - 245 g (males)
- Fasting period before study: yes, overnight
- Housing: The rats housed individually in Macrolon cages (area 800 cm², height 17 cm)
- Diet (e.g. ad libitum): Haltungsdiat "ALMA 0801 H 1003", twice 8 g daily
- Water (e.g. ad libitum): Free access by daily changing of the watering bottles
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12:12 - Route of administration:
- oral: capsule
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000, 2800, or 3920 mg test item in each 1000µl pure sesame oil
- Amount of vehicle (if gavage): 1000µl
- Purity: pure
MAXIMUM DOSE VOLUME APPLIED: no exceeding the limit volume of 1 ml/100 g body weight - Doses:
- 2000, 2800, or 3920 mg/kg
- No. of animals per sex per dose:
- Group I and II (2000 resp. 2800 mg/kg, each group consists of 5 male and 5 female Sprague-Dawley rats)
Group III (3920 mg/kg, the group consists of 5 male Sprague-Dawley rats)
Control group (sesame oil): (the group consists of 2 male and 2 female Sprague-Dawley rats) - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The following times of death after administration of the test item are recorded:
2000 mg/kg:
rat No. 636 3 hours
2800 mg/kg:
rat No. 653 and 654 10 minutes
rat No. 651 1.5 hours
rat No. 644 2 hours
rat No. 642 3 hours
3920 mg/kg:
rat No. 656 2.5 hours
The LD50 value of the test item turned out to be unquantifiable in this toxicity study because of the non-linear dose relationship of the mortality rate observed. However, it can be deduced from the mortality rate almost certainly that the LD50 for rats of both sexes is greater than 2000 mg/kg body weight. - Clinical signs:
- other: Acute toxicological symptoms attributed to the exposure to the test item could be observed in five rats of group I (2000 mg/kg) and in all rats of group II (2800 mg/kg) and of group III (3920 mg/kg).
- Gross pathology:
- The post-mortem findings of all 25 rats of the test show no macroscopical organ changes in the pathological examination.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU implementation
- Conclusions:
- The study was performed on the registered substance itself according to OECD 401 under GLP, the report is well documented. Hence, the results can be considered as sufficiently reliable to assess the acute toxicity of the test item to rats via the oral route. The LD50 was determined to be > 2000 mg/kg, hence, the substance does not need to be classified as acutely toxic acc. Regulation 1272/2008.
- Executive summary:
The acute oral toxicity of the test item was determined acc. OECD TG 401 under GLP.
The test substance was administered orally in a single dose to three groups of Sprague-Dawley rats:
Group I (10 rats, 5 male and 5 female): 2000 mg/kg applied
Group II (10 rats, 5 male and 5 female): 2800 mg/kg applied
Group III (5 rats, male): 3920 mg/kg applied
Mortality
group
I
II
III
2000
2800
3920
mg/kg
mg/kg
mg/kg
mortality
number
male
1 outof 5
2 out of 5
1 out of 5
female
0 outof 5
3 out of 5
Not tested
Acute toxicological symptoms attributed totheexposure to the test item could be observed in five rats of group I (2000 mg/kg) and in all rats of group II (2800 mg/kg) and of group III (3920 mg/kg). The post-mortem findings of all 25 rats of the test show no macroscopical organ changes inthepathological examination. The LD 50 value of the test item turned out to be unquantifiable in this toxicity study because ofthenon-linear dose relationship of the mortality rate observed. However, it can be deduced from the mortality rate almost certainlythatthe LD50 for rats of both sexes is greater than 2000 mg/kg body weight. Testing of further groups was omitted due to animal welfare.
Based on the obtained results, the substance does not need to be classified as acutely toxic acc. Regulation 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available study was performed according to OECD 401 under GLP. The method is to be considered scientifically reasonable. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is >2000 mg/kg bw, in rats, so an underestimation of the actual hazard is unlikely. Hence, the database is of high quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the available study no indication is given that the substance would need to be classified as acute toxic or poses any relevant risk for humans, as the animal model is considered sufficient to assess the inherent hazard of the substance via the oral route. Testing for toxicity via inhalation was considered not necessary as it would reveal no additional information and is also scientifically not relevant due to the intrinsic properties of the test item, e.g. low vapour pressure. Further, testing via the dermal route can be omitted asthe substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).The tonnage-driven data requirements are hence fully met, no data gaps were identified, and the substance does not need to be classified as acute toxic.
Justification for classification or non-classification
The available study via the oral route revealed a LD50 value above 2000 mg/kg in rats, which is the limit value for classification as acutely toxic Cat. 4 via the oral route. Also, the given physico-chemical and toxicological data give no indication that testing for acute inhalation toxicity would result in LC50 values below 5 mg/L or testing for acute dermal toxicity would result in LD50 values below 2000 mg/kg. Hence, classification criteria are not met and the registered substance does not need to be classified as acute toxic according to Regulation 1272/2008 and amendments.
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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