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Diss Factsheets
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EC number: 934-405-7 | 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:
- 2015-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- first 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.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- 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.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- 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.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch No.of test material:040802#
- Expiration date of the lot/batch: 06.08.2016
- Purity test date:08/01/2015
- purity: 99.17%
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 1.008 was applied
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
OTHER SPECIFICS:
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source:
- 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: 154 g
Animal n°2: 165 g
Animal n°3: 146 g
Animal n°4: 146 g
Animal n°5: 136 g
- Fasting period before study: between 16 and 19 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: 0.504g test item into vehicle (final volume 2.5 ml)
Animal 3/4/5: 2.016g 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 other:gross pathological changes
Results and discussion
- Preliminary study:
- 1 animal at 2000 mg/kg body weight: no signs
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:
- none
- Clinical signs:
- 2 animals showed slight piloerection the first day, between 120 and 180 min post-administration, but it is not considered to be related to the test item but to the administration procedure and the possible stress induced. No specific findings during the rest of the observation period for these 2 animals nor for the 3 3 others during all the observation duration.
- Body weight:
- None animals showed weight loss during the observation period.
- Gross pathology:
- None animals showed specific gross pathological changes during the observation period.
Any other information on results incl. tables
Clinical signs - Individual data :
Animal No./Sex | Time of observation post-dose | Observations |
Dose level 2000 mg/kg Body Weight | ||
1/ female 2/ female |
0 min - 60 min | no specific findings |
1/ female 2/ female |
120 min - 180 min | slight piloerection |
1/ female 2/ female |
240 min - 15 days | no specific findings |
3/ female | 0 min - 15 days | no specific findings |
4/ female | 0 min - 15 days | no specific findings |
5/ female | 0 min - 15 days | no specific findings |
Based on these results and according to the acute toxic class method regime no further testing was required.
Absolute body weights in grams and body weight gain in %:
Animal No. / sex | Starting dose (mg/kg bw) | Body Weight (g) - Day 1 | Body Weight (g) - Day 8 | Body Weight (g) - Day 15 | Body Weight Change in comparison to day 1 (%) |
1/Female | 2000 | 154 | 164 | 183 | 19 |
2/Female | 2000 | 165 | 181 | 186 | 13 |
3/Female | 2000 | 146 | 167 | 174 | 19 |
4/Female | 2000 | 146 | 171 | 185 | 27 |
5/Female | 2000 | 136 | 165 | 175 | 29 |
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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