Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- Few times during the quarantine air temperature exceeded 25 °C. It had no influence on the study course and results.
- 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.:2/3
- Expiration date of the lot/batch: 2009-06-06
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/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: females 9 weeks, males 10 weeks
- Weight at study initiation: see Table 2 in the section Any other informartion on results incl. tables
- Fasting period before study: animals were not fasted prior to the experiment
- 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. After application of the test item each animal was kept individually in a cage. After removal of the test item from the skin, during the following days of the experiment, animals were kept five per cage, each sex separately. UV-sterilized wooden shavings were used as the bedding.
- Diet (e.g. ad libitum): ad libitum. The animals were given standard granulated "Murigran" fodder 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: the animals were quarantined and observed daily for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 40 - 70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- other: The test item was held in contact with the skin with a porous gauze dressing
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: masel 42 cm2, females 36 cm2
- % coverage: ca. 10
- Type of wrap if used: the gauze patches were covered with PVC foil and elastic bandage was used to make circular protecting band
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test item was removed from the skin using water
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: evaluation of general condition of animals was performed twice a day (once a day on days off). Detailed clinical observations were performed at hourly intervals after administration of the test item (day 0). From 1st to 14th day of the observation period detailed clinical observations were performed once a day. bw of animals was individually determined for each animal directly before administration of the test item and then on the 7th and the 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/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: Following administration of the test item, no pathological changes were stated on skin of males and females. No other clinical signs were stated during the test in any of the animals - see Table 1 in the section Any other information on results incl. tabl
- Gross pathology:
- No pathological changes were stated in animals at the necropsy.
Any other information on results incl. tables
Table 1. Acute dermal toxicity study on rats – clinical signs – overall list
Dose mg/kg bw |
Sex |
Day after administration |
No. of alive animals |
Rat No. |
||||
1 |
2 |
3 |
4 |
5 |
||||
2000 |
males |
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 |
females |
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 |
NC – no changes
Table 2. Acute dermal toxicity study on rats – body weight of animals (g)
Dose mg/kg bw |
Sex |
Rat No. |
Day |
Body weight gain (0→14) |
||
0 |
7 |
14 |
||||
2000 |
males |
1 2 3 4 5 |
315 297 282 297 279 |
325 311 299 305 294 |
349 343 312 314 309 |
34 46 30 17 30 |
females |
1 2 3 4 5 |
217 213 211 223 211 |
236 218 222 233 211 |
249 242 239 251 227 |
32 29 28 28 16 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- As median dermal 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.
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.