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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-453-2 | 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guideline. Study was originally judged Klimisch 1. However, according to the "Practical guide 6: How to report read-across and categories" the maximum score for read-across is 2.
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:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Biofert Plusz
- IUPAC Name:
- Biofert Plusz
- Details on test material:
- -Name of test material (as cited in study report): Biofert Plusz
Details are presented in "Confidential details on test material"
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: Harlan, Netherlands
-Age at study initiation: 8 - 12 weeks
-Weight at study initiation: 19.6 – 23.3 g
-Housing: Individually in Macrolon cages Type I
-Diet: Certified standard pellets ad libitum
-Water: Tap water ad libitum
-Acclimation period: at least 5 days prior to first dosing
ENVIRONMENTAL CONDITIONS
-According to guideline
IN-LIFE DATES
2008-04-08 to 2008-04-23
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- The test item in the main study was assayed at 0, 25, 50 and 100% of the original liquid substance (0, 7.03, 14.05 or 28.1% dry mass)
- No. of animals per dose:
- 4 f in the main study
- Details on study design:
- RANGE FINDING TESTS
Compound solubility: The highest concentration which could be technically used was a 50% (14.05% dry mass) suspension in propylene glycol. Upon sponsors consent propylene glycol was used as a vehicle.
Irritation: A pre-test was performed in two mice with concentrations of 10, 25, 50 and 100% of the original liquid substance (2.81, 7.03, 14.05, or 28.1% dry mass, respectively) on one ear each on three consecutive days (clinical signs scored 24 h after each application). After the second application and onwards the highest dose (100%) induced redness of the ear skin. All other concentrations did not induce any signs of irritation or systemic toxicity.
MAIN STUDY
Criteria used to consider a positive response:
1.) Exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
2.) Data are compatible with a conventional dose response, although allowance must be made for either local or toxicological response.
TREATMENT PREPARATION AND ADMINISTRATION
Each test group of mice (n=4 per group) was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations. The application volume (25 uL) was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days. Controls were treated with vehicle only. Five days after the first topical application, all mice were administered with 250 uL of 81.6 uCi/mL 3HTdR (3H-methyl thymidine) by intravenous injection via tail vein. Approximately five hours after treatment with 3HTdR all mice were necropsied and the draining lymph nodes were excised and pooled per group (8 nodes per group). The level of 3HTdR incorporation was than measured on a beta-scintillation counter. The beta-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations were calculated in body weight tables
Results and discussion
- Positive control results:
- A GLP study with a positive control substance (alpha-Hexyl cinnamic aldehyde) was performed with test item concentrations (w/v) of 5, 10 and 25% in an acetone:olive (4:1) vehicle in February 2008 and included as reference into this study. The positive outcome of the study demonstrated the sensitivity and validity of the test system.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 1.99, 2.18 and 1.47 for the three dose groups
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 339.0, 674.4, 738.1 and 497.5 for controls and the three dose groups, respectively
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- There were no clinical signs in any dose group and also the body weights were within the common range. In none of the 3 tested groups the stimulation index was > 3; therefore an EC3 value could not be calculated. Thus the test item Biofert Plusz was found not to be a skin sensitizer under the described conditions.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)