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EC number: 614-406-6 | CAS number: 68308-61-2
- 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:
- 2008-04-09 to 2009-04-15
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
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.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- esterification products of castor oil and polyphosphoric acids
- EC Number:
- 614-406-6
- Cas Number:
- 68308-61-2
- Molecular formula:
- C57H107P3O18
- IUPAC Name:
- esterification products of castor oil and polyphosphoric acids
- Details on test material:
- - Name of test material (as cited in study report): GARDO TP10451
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: 2939R
- Expiration date of the lot/batch: 2010-02-18
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca Ola Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: WOBE Kereskedelmi Kft.H-1164, Budapest, Garmada u. 10.
- Age at study initiation: Young adult, 9-10 weeks old, age-matched within one week
- Weight at study initiation: The weight variation in animals involved in the study did not exceed 20 % of the mean weight.
- Cage type: Type II. polypropylene/ polycarbonate
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, as for human consumption from 500 mL bottle ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchange/hour by central air-condition system.
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50%, 25% and 10%
- No. of animals per dose:
- 4 animals/treatment group
- Details on study design:
- In the main assay sixteen female CBA/Ca mice were allocated to four groups of four animals each:
- three groups received the appropriate formulation of GARDO TP10451 at concentrations of 50 %, 25 % or 10 %,
- the negative control group received the solvent Acetone: Olive oil 4:1 mixture (AOO).
Each substance was applied on the external surface of each ear (25 µL/ear) for three consecutive days (Day 0, 1 and 2) at the appropriate concentrations. On Day 5, the cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl-thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- NA
Results and discussion
- Positive control results:
- The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI >= 3) was noted for HCA with stimulation index value of 11.3 in accordance with our previous data, demonstrating the test reliability.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- A lymphoproliferative response (SI >= 3) was noted for GARDO TP10451 at concentrations of 50 % and 25 %. No lymphoproliferative response was observed at concentration of 10 %. The stimulation index values were 3.1, 3.1 and 1.3 at concentrations of 50 %, 25 % and 10 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: NA
Any other information on results incl. tables
Clinical Signs and Mortality:
No mortality or signs of systemic toxicity were observed during the study. No treatment related effects were observed on animal body weights. Slight irritation (redness at the base of the ears) with recovery was observed in all of the test item treated groups with dose dependent intensity. No other cutaneous effect was observed.
Proliferation Assay:
A lymphoproliferative response (SI >= 3) was noted for GARDO TP10451 at concentrations of 50 % and 25 %. No lymphoproliferative response was observed at concentration of 10 %. The stimulation index values were 3.1, 3.1 and 1.3 at concentrations of 50 %, 25 % and 10 %, respectively. The stimulation index values were compatible with the conventional biological dose-response.
Reliability of the Assay:
The result of the latest reliability check was used to demonstrate the appropriate performance of the assay in accordance with the OECD guideline. The positive control substance alpha-Hexylcinnamaldehyde (HCA) was examined at a concentration of 25 % in the relevant vehicle. A significant lymphoproliferative response (SI >= 3) was noted for HCA with stimulation index value of 11.3 in accordance with our previous data, demonstrating the test reliability.
Interpretation of Observations:
The maximum concentration of test item in an acceptable solvent was established according to the principles of the relevant guidelines. The maximum available concentration based on solubility was 50 % (% w/v) in Acetone : Olive oil 4:1 mixture (AOO) and in N,N-Dimethylformamide (DMF). Since AOO is the preferred solvent by the relevant guideline, this solvent was selected to be used. Although loss of hair was observed with test item concentration of 50 % in the preliminary test it was not significant, so to meet the requirement of the OECD 429 guideline to test as high concentration as possible 50 % was accepted as the maximum.
A lymphoproliferative response (SI >= 3) was noted for GARDO TP10451 at concentrations of 50 % and 25 %. No lymphoproliferative response was observed at concentration of 10 %. The proliferation values obtained corresponded to the conventional biological dose-response.
Although irritation was observed in the main assay it was not excessive. It is known that some non-sensitising irritant chemicals (such as sodium dodecyl sulphate) can give a slight positive response in the LLNA but there are also many irritants which do not give such a response. It is plausible that the slight increase in proliferation seen in this study could be secondary to the irritation effect, but there is no specific evidence to make this argument. So in line with the guidelines, the test item must be considered to be positive.
The EC3 value (the theoretical concentration of the test item in the test solution, leading a three fold increase of lymph node cell proliferation over the control) was estimated by linear interpolation using the reported SI values and the corresponding concentrations immediately above and below the SI value of 3. The estimated EC3 value of GARDO TP10451 was 24.2 % in this LLNA. On the basis of published classification of contact allergens according to their potency GARDO TP10451 can be ranked among weak sensitisers (EC3 (%)
Applicant's summary and conclusion
- Interpretation of results:
- other: weak-sensitiser
- Conclusions:
- Under the conditions of the present assay GARDO TP10451, dissolved in an appropriate solvent up to the maximum feasible concentration (50 %), was shown to have weak sensitisation potential (weak-sensitiser) at slightly irritating concentrations in the Local Lymph Node Assay.
Thus, the substance is to be classified as "Sensitizing by skin contact" (R43). The registrant proposes to perform an in vivo study to verify this classification. - Executive summary:
A lymphoproliferative response (SI >= 3) was noted for GARDO TP10451 at concentrations of 50 % and 25 %. No lymphoproliferative response was observed at concentration of 10 %. The stimulation index values were 3.1, 3.1 and 1.3 at concentrations of 50 %, 25 % and 10 %, respectively. The stimulation index values were compatible with the conventional biological dose-response. No mortality or systemic clinical signs were observed during the study. No treatment related effect on the body weights was observed.
Slight irritation (redness at the base of the ears) with recovery was observed in all of the test item treated groups with dose dependent intensity. No other cutaneous effect was observed.
Thus, under the conditions of the present assay GARDO TP10451, dissolved in an appropriate solvent up to the maximum feasible concentration (50 %), was shown to have weak sensitisation potential (weak-sensitiser) at slightly irritating concentrations in the Local Lymph Node Assay.
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