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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 482-200-1 | 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:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 482-200-1
- EC Name:
- -
- Cas Number:
- 1184-10-7
- Molecular formula:
- C36H30N3O6P3
- IUPAC Name:
- hexaphenoxy-1,3,5,2λ⁵,4λ⁵,6λ⁵-triazatriphosphinine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch/Lot number: 190202
Description: White or light yellow crystal
Purity: 99.53%
Expiry date: 31 January 2021
Storage conditions: Controlled room temperature (15-25 ºC, below 70% relative humidity).
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: CBA/CaCrl mice
Source: Charles River UK Limited, Manston Road, Margate Kent, CT9 4LT, United Kingdom
Hygienic level: SPF at arrival; standard housing conditions during the study
Justification of strain: On the basis of OECD Guideline, mice of CBA/Ca or CBA/J strain can be used. Females are used because the existing database is predominantly based on females.
Number of animals: 4 animals / group
Sex: Female, nulliparous, non-pregnant
Age of animals at starting: 8 weeks old (age-matched, within one week)
Body weight range at starting: 18.0 – 19.8 grams (The weight variation in animals in the study did notexceed ± 20% of the mean weight.)
Acclimatisation time: 13 days
Animal health: Only healthy animals were used for the study. Health status was certified by the veterinarian.
Housing / Enrichment: Group caging / Additional enrichment (hiding tunnels) wasalso used during the study.
Cage type: Type II. polypropylene / polycarbonate
Bedding and nesting: Bedding and nesting materials were available to animalsduring the study
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.1 – 23.8°C
Relative humidity: 22 - 73%
Ventilation: 15-20 air exchanges/hour
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10%, 5%, 2.5%
- No. of animals per dose:
- 4
- Details on study design:
- In the main assay, twenty female CBA/CaCrl mice were allocated to five groups, each group comprised four animals:
- three groups of animals received HPCTP (formulated in DMF) at 10, 5, and 2.5% (w/v), respectively,
- a negative control group received the vehicle (DMF) only,
- a positive control group received 25% (w/v) HCA (dissolved in DMF).
The test item solutions were applied to the dorsal surface of the ears of the experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3) and then maintained on study for an additional 3 days. Cell proliferation in the (local) lymph nodes was assessed by measuring disintegrations per minutes after the incorporation of tritiated methyl thymidine (3HTdR) into the lymph nodes and the values obtained were used to calculate stimulation indices (SI) in comparison with the control group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive controls responded as expected
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 0.6
- Test group / Remarks:
- HPCTP 10%(w/v) in DMF
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- HPCTP 5%(w/v) in DMF
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- HPCTP 2.5%(w/v) in DMF
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
Any other information on results incl. tables
No test item residue was observed in any of the animals. There were no indications of any irritancy at the site of application. No marked body weight losses (≥5%) were observed during the study in any of the animals. The results of the proliferation assay are summarised in Table below. The appearance of the lymph nodes was normal in all animals.
Table: DPM, DPN and Stimulation IndexValues for all Groups
Test Group Name |
Measured DPM / group |
DPM |
Number of lymph nodes |
DPN |
Stimulation Index |
Background (5% (w/v)TCA) |
33.5 |
- |
- |
- |
- |
Negative control (DMF) |
4189 |
4155.5 |
8 |
519.4 |
1.0 |
HPCTP 10%(w/v) in DMF |
2717 |
2683.5 |
8 |
335.4 |
0.6 |
HPCTP 5%(w/v) in DMF |
4045 |
4011.5 |
8 |
501.4 |
1.0 |
HPCTP 2.5%(w/v) in DMF |
4226 |
4192.5 |
8 |
524.1 |
1.0 |
Positive control(25%(w/v) HCA in DMF) |
24456 |
24422.5 |
8 |
3052.8 |
5.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of the present assay, HPCTP, tested in DMF, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay. No classification/labelling is triggered according to Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 7) 2017.
- Executive summary:
The aim of this study was to determine the skin sensitisation potential of HPCTP following dermal exposure in mice. The study was performed with vertebrate animals as classification by use of in vitro alternatives was not possible for this test item. The minimum number of animals was used, corresponding to the regulatory guidelines being followed. The solubility of the test item was examined in a short Preliminary Compatibility Test. The following standard OECD 429 vehicles were assessed: Acetone: Olive oil 4:1 (v/v) mixture, N,N-dimethylformamide (abbreviated as DMF), Methyl ethyl ketone, Propylene glycol, Dimethyl sulfoxide, 1% aqueous Pluronic® PE9200, and cyclohexane. The best vehicle taking into account the test item characteristics, and the requirements of the relevant OECD guideline was considered to be DMF. The 10% (w/v, i.e. 0.1 g per mL with added vehicle) format was the highest concentration which was suitable for the preliminary test. The 10% and 5% (w/v) formulations appeared to be solutions by visual examination. The Preliminary Irritation/Toxicity Test was started according to the Study Plan on CBA/CaCrl mice using two doses (2 animals/dose) with the concentrations of 10% (w/v) and 5% (w/v) in DMF. Based on the results, 10% (w/v) was selected as top dose for the main test.
In the main assay, twenty female CBA/CaCrl mice were allocated to five groups, each group comprised four animals: - three groups of animals received HPCTP (formulated in DMF) at 10, 5, and 2.5% (w/v), respectively, - a negative control group received the vehicle (DMF) only, - a positive control group received 25% (w/v) HCA (dissolved in DMF). The test item solutions were applied to the dorsal surface of the ears of the experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3) and then maintained on study for an additional 3 days. Cell proliferation in the (local) lymph nodes was assessed by measuring disintegrations per minutes after the incorporation of tritiated methyl thymidine ( 3 HTdR) into the lymph nodes and the values obtained were used to calculate stimulation indices (SI) in comparison with the control group. There was no mortality or signs of systemic toxicity observed during the study. No marked body weight losses (≥5%) were observed during the study in any of the animals. The stimulation index values were 0.6, 1.0 and 1.0 at concentrations of 10, 5 and 2.5% (w/v), respectively. The size of lymph nodes was in good correlation with this conclusion. The SI value for the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in the same vehicle was 5.9, therefore demonstrating the appropriate performance of the assay. In conclusion, under the conditions of the present assay, HPCTP, tested in DMF, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay. No classification/labelling is triggered according to Regulation (EC) No 1272/2008 (CLP) / GHS (rev. 7) 2017.
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.