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EC number: 700-427-9 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: this study was planned and executed in accordance with relevant guidelines as well as the requirements of the GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Atlen SK
- IUPAC Name:
- Atlen SK
- Details on test material:
- - Name of test material (as cited in study report): Atlen SK
- Substance type: organic, UVCB
- Physical state: liquid
- Lot/batch No.: probka of 12-12-2008
- Expiration date of the lot/batch: 2009-12-13
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: conventional husbandry of Institute of Occupational Medicine, Łódź, Poland
- Age at study initiation: 10 weeks
- Weight at study initiation: see Table 2 in section Any other information on results incl. tables
- Fasting period before study: the day before the start of the experiment (about 19 hrs before administration of the test item) the food was withheld. Water was still available. The food was restored 3 hours after administration of the test item.
- Housing: The animals were kept in cages with plastic bottom and wired lid of dimensions: (length x width x height) 58 x 37 x 21 cm. The animals were kept in the cages individually (the sighting study) or four rats per cage (the main study). UV sterilized wooden shaving were used as the bedding.
- Diet (e.g. ad libitum): ad libitum. The animals were given standard granulated "Murigran" foodstuff produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum. The animals were given tap water.
- Acclimation period: prior to the start of the dosing the animals were quarantined and observed daily for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 37 - 60
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 (artificial light)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: corn oil is typically used in oral acute toxicity studies and it is compatibile with Atlen SK
MAXIMUM DOSE VOLUME APPLIED: 0.5 ml per 100 g of bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: evaluation of general condition of animals was conducted twice a day (once on days off). detailed clinical observations were performed at the day of administration after 10, 30 and 60 minutes since administration and then in hourly intervals - till the 5th hour after administration. From 1st to 14th day of the observation period clinical observations were performed once a day. bw of animals was individually determined directly before administration of the test item (day 0) and then on 7th and 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
- Preliminary study:
- The sighting study performed on a single animal at the dose of 2000 mg/kg bw revealed no signs of toxicity.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the test.
- Clinical signs:
- other: No clinical signs were stated during the test in any of the animals - see Table 1 in the section Any other information on results incl. tables.
- Gross pathology:
- No pathological changes in any of the animals were stated at the necropsy.
Any other information on results incl. tables
Table 1. Atlen SK Acute oral toxicity on rats – clinical signs – overall list
Dose (mg/kg b.w.) |
Day after administration |
Number of alive animals |
Rat No. |
||||
1* |
2 |
3 |
4 |
5 |
|||
2000 |
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 |
5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
NC NC NC NC NC NC NC NC NC NC NC NC NC NC NC |
* female from the sighting study
NC = no changes
Table 2. Atlen SK Acute oral toxicity on rats – body weight of animals (g)
Dose (mg/kg b.w.) |
Rat No. |
Day of experiment |
Body weight gain (0 →14) |
||
0 |
7 |
14 |
|||
2000 |
1* 2 3 4 5 |
196 210 208 209 214 |
210 238 237 234 230 |
235 248 254 230 246 |
39 38 46 21 32 |
* female from the sighting study
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As median oral acute dose (LD50) for Atlen SK is > 2000 mg/kg it is not classified as dangerous in accordance with both the DSD and the CLP regulation.
- Executive summary:
Presented results originate from a guideline study conducted in accordance with the requirements of the GLP. Hence, this information can be considered reliable and suitable for use as the key study for this endpoint.
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