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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 918-205-7 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-21 to 2008-06-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ethyltriphenylfosfonium bromide
- EC Number:
- 216-223-3
- EC Name:
- Ethyltriphenylfosfonium bromide
- Cas Number:
- 1530-32-1
- Molecular formula:
- C20H20P.Br
- IUPAC Name:
- bromo(ethyl)triphenylphosphorane
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species: Mouse, CBA strain, inbred, SPF-Quality
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 19 - 24 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.1 - 23.7
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 1, 2.5 and 5%
- No. of animals per dose:
- 5
- Details on study design:
- - Compound solubility:
-- Vehicle: Propylene glycol (Merck, Darmstadt, Germany)
-- Rationale: The vehicle was selected based on trial formulations performed at the testing laboratory and on test substance data supplied by the sponsor.
-- Preparation: The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
-- Test substance concentrations selected for the main study were based on the results of a preliminary study. At a 1, 2.5 and 5% test substance concentration no severe irritation was observed.
- Dose selection: Test substance concentrations selected for the main study were based on the results of a preliminary study.
- Ear thickness measurements: no data
- Grading of skin reactions: Erythema and edema were scored similar to the grading system stipulated in OECD Guideline 404
MAIN STUDY
Induction - Days 1, 2 and 3:
The dorsal surface of both ears was epidermally treated (25 µL/ear) with the test substance concentration, at approximately the same time per day. The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. The control animals were treated the same as the experimental animals, except that, instead of the test substance, the vehicle alone was administered.
Treatment· Day 6:
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 µCi of 3H-methyl thymidine (GE Health care, Buckinghamshire, UK). After approximately five hours, all animals were killed by intraperitoneal injection with pentobarbital Euthesate® (0.2 mL/animal) (Ceva Sante Animale BV, Naaldwijk, The Netherlands). The draining (auricular) Iymph node of each ear was excised. The relative size of the nodes (as compared to normal) was estimated by visual examination and abnormalities of the nodes and surrounding area were recorded. The nodes were pooled for each animal in approximately 3 mL PBS.
Tissue processing for radioactivity - Day 6:
A single cell suspension of Iymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze (diameter 1251-1m). LNC were washed twice with an excess of PBS by centrifugation at 200g for 10 minutes at 4° C. To precipitate the DNA, the LNC were exposed to 5% trichloroacetic acid (TCA) (Merck, Darmstadt, Germany) at 4° C during the night.
Radioactivity measurements - Day 7:
Precipitates were recovered by centrifugation, resuspended in 1 mL TCA and transferred to 10 mL of Ultima Gold cocktail (PerkinEImer Life and Analytical Sciences, Boston, MA, US) as the scintillation fluid. Radioactive measurements were performed using a Packard scintillation counter (2800TR). Counting time was to a statistical precision of ±0.2% or a maximum of 5 minutes whichever comes first. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM).
Observations:
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body weights: On Days 1 (pre-treatment) and 6.
- Necropsy: The animal found dead in the main study was subjected to necropsy for gross macroscopic examination.
- Irritation: On Day 3 (3-4 hours after treatment), the skin reactions were assessed. Erythema and edema were scored similar to the grading system stipulated in OECD Guideline 404.
Interpretation:
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group.
If the results indicate a SI >= 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM, NIH publication; No 99-4494, February 1999
The results were evaluated according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations and the EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Communities). Consideration was given to the EC3 value (the estimated test substance concentration that will give a SI =3) (Basketter et al., Appl ToxicoI1999;19:261-266). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The six monthly reliability check with Hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at testing laboratory is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 1 and 2.5%
Any other information on results incl. tables
Preliminary irritation study:
At a 10 and 25% test substance concentration, piloerection, ptosis, uncoordinated movements, squeaking when touched, hypothermia and/or flat posture were noted and the animals were sacrificed in extremis at Day 2. At a 1, 2.5 and 5% test substance concentration no signs of systemic toxicity were noted and no severe irritation was observed.
Based on the results, the highest test substance concentration selected for the main study was a 5% concentration.
Main study:
At Day 3, one animal at 5% was found dead before scoring of the skin reactions. Macroscopic post mortem examination of the animal found dead did not reveal any abnormalities. Based on the observed mortality at 5% in the main study and taking the observed toxicity at 10 and 25% in the preliminary irritation study into account, the results of the group at 5% could not be used for interpretation.
- Skin reactions / Irritation:
No skin reactions were observed in any of the control animals and animals at 1 and 2.5%.
- Macroscopy of the auricular Iymph nodes and surrounding area:
One node of one control animal was considered enlarged in size and both nodes of one animal at 2.5% were considered reduced in size. The other nodes of controI animals and animals at 1 and 2.5% were considered normal in size. No macroscopic abnormalities of the surrounding area were noted.
- Body weights:
Body weights and body weight gain of experimental animals at 1 and 2.5% remained in the same range as controls over the study period.
- Radioactivity measurements:
The median DPM/animal values are reported due to possible outlier responses for individual animals within groups.
Median DPM/animal values for the experimental groups treated with test substance concentrations 1 and 2.5% were 412 and 417 respectively. The median DPM/animal value for the vehicle control group was 403.
- Toxicity and Mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in control animals and animals at 1 and 2.5% of the main study.
- Conclusion:
Based on the observed mortality at 5% in the main study and taking the observed toxicity at 10 and 25% in the preliminary irritation study into account, the results of the group at 5% could not be used for interpretation.
The SI values calculated for the substance concentrations 1 and 2.5% were 1.0 and 1.0 respectively.
Since there was no indication that the test substance could elicit an SI >=3 when tested up to 2.5%, it was established that the EC3 value (if any) exceeds 2.5%.
The six monthly reliability check with Hexylcinnamaldehyde, indicates that the Local Lymph Node Assay as performed at the test laboratory is an appropriate model for testing for contact hypersensitivity.
Based on these results:
According to the recommendations made in the test guidelines, the test item is not regarded as skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The SI values calculated for the substance concentrations 1 and 2.5% were 1.0 and 1.0 respectively. Since there was no indication that the test substance could elicit an SI >=3 when tested up to 2.5%, it was established that the EC3 value (if any) exceeds 2.5%.
Based on these results:
- according to the recommendations made in the test guidelines, Ethyltriphenylfosfonium bromide is not regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2004), Ethyltriphenylfosfonium bromide does not have to be classified for sensitization by skin contact.
- according to the criteria of REGULATION (EC) No 1272/2008, Ethyltriphenylfosfonium bromide does not have to be classified and has no obligatory labeling requirement for sensitization by skin contact.
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.