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Diss Factsheets
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EC number: 934-407-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05/02/2016 to 23/03/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 1st addendum, 2001
- Deviations:
- yes
- Remarks:
- 3 animals were between 7-8 weeks old because of limited availability of animals but this deviation did not influence the quality or integrity of the results. Prior to dosing, food was withheld for 20 to 22 hours (technical reason).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- EPA 712-C-02-190, 12/2002
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:040801#
- Expiration date of the lot/batch: 05.08.2016
- Purity test date:08/01/2015
- purity: 91.61%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable in water, instable after repeated contact to air
- Solubility and stability of the test substance in the solvent/vehicle: 100% - table in water, instable after repeated contact to air
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dilution in aqua ad injectabilia
- Preliminary purification step (if any): a correction factor of 1.092 was applied
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: animal n°1 and 2: 8-9 weeks
Animal n° 3-5 : 7-8 weeks
- Weight at study initiation: Animal n°1: 170 g
Animal n°2: 172 g
Animal n°3: 135 g
Animal n°4: 138 g
Animal n°5: 141 g
- Fasting period before study: between 20 and 22 hours prior testing (access to water permitted)
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102151120)
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice (lot no. 0922) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hr dark / 12 hr light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage): Animals n° 1/2: 2.5 ml
Animals 3/4/5: 10 ml
- Justification for choice of vehicle: chosen due to its non-toxic characteristics
- Lot/batch no. (if required): 511535 (AlleMan Pharma)
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION (if unusual):
Animal 1/2: 0.546g test item into vehicle (final volume 2.5 ml)
Animal 3/4/5: 2.184g test item into vehicle (final volume 10 ml) - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once during the first 30 min and with special attention during the first 4 hours post-dose. Animals were weighed on day 1 prior to the administration, day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, other: gross pathological changes - Statistics:
- Not necessary
Results and discussion
- Preliminary study:
- No acute oral toxicity characteristics after a single dose administration at 2000 mg/kg body weight on one animal.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat. (total fraction)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No
- Clinical signs:
- 1 animal showed spontaneous activity slightly reduced, piloerection (slight), and eyes half closed from 2 to 3h post-dosing.
1 animal showed same clinical signs from 2h to 4h post-dosing.
No specific findings in the 3 other animals. - Body weight:
- Two out of 5 animals showed weight loss during the first study week but all of the animals showed weight gain during the second week.
- Gross pathology:
- None animals showed specific gross pathological changes during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the OECD 420 guideline, a single oral application of this substance to rats at a dose of 2000 mg/kg body weight was associated with minimal signs of toxicity but no mortality.
The median lethal dose of this substance after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat) above 2000 mg/kg and inferior or equal to 5000 mg/kg bw. - Executive summary:
Five female WISTAR Crl: WI(Han) rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The solid test item was suspended in the vehicle aqua ad injectablia (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study showing minimal signs of toxicity between 2 hours and 4 hours post-dosing.
The most relevant clinical findings were slight reduced spontaneous activity, slight piloerection and eyes half closed.
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain except for animal no. 5 which showed a 14.9% weight loss during the first week post-dose but recovered a normal weight gain the week after.
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
LD50: > 2000 mg/kg ≤ 5000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Number of animals: 5
Vehicle: aqua ad injectabilia (sterile water)
Method: OECD 420, Commission Regulation (EC) 440/2008
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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