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EC number: 701-298-1 | 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
Endpoint summary
Administrative data
Description of key information
- Skin sensitisation: not sensitising (OECD 429, Kr.1, GLP).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 November to 24 November 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Alkenyl phosphonate
- Expiration date of the lot/batch: 09 September 2017
- Purity test date: 08/06/2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 ºC, below 70 RH%)
- Stability under test conditions: yes - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo. San Pietro al Natisone (UD). Zona Industriale Azzida, 57, 33049 Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adults, 8-12 weeks old (age-matched, within one week)
- Weight at study initiation: The weight variation in animals involved in the study will not exceed ± 20 % of the mean weight (17 - 27 g)
- Housing :Group caging / Mice will be provided with glass tunnel-tubes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchange/hour
- IN-LIFE DATES: From: To: - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 2.5, 5 and 10% in AOO.
- No. of animals per dose:
- 4 females.
- Details on study design:
- PRELIMINARY TEST:
To assess the irritant potential of the test substance (through ear thickness measurement), a preliminary test was performed on 4 animals, as follows:
- the test substance was prepared at the concentrations of (to complete).
- for three consecutive days, the animals received applications of 25 µL of the dosage form preparations to the external surface of both ears (one concentration per ear),
- measurement of the ear thickness (using a micrometer) was performed each day before treatment and 24 hours after the last application.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Kimber and Dearman
- Criteria used to consider a positive response: The test substance was considered as a skin sensitizer when the Stimulation Indices (SI) for a dose group is ≥ 3. Other relevant criteria such as cellularity, radioactivity levels and ear thickness were also taken into account for the interpretation of results.
TREATMENT PREPARATION AND ADMINISTRATION:
In the main test, twenty female CBA/Ca mice were allocated to five groups:
- three treated groups of four animals receiving the test substance Alkenyl phosphonate at the concentrations 1, 2.5, 5 and 10%
- one negative control group of four animals receiving the vehicle
- one positive control group of four animals receiving the reference item, alpha-hexylcinnamaldehyde (HCA), a moderate sensitizer, at the concentration of 25%
On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an optimized application of the test substance, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application.
On day 6, all animals of all groups received a single intravenous injection of 250 µL of 0.9% NaCl containing 20 µCi of tritiated methyl-thymidine (3H-TdR) via the tail vein. Lymph node cell proliferative responses were measured on day 6. The lymph nodes were pooled for each experimental group.
The obtained values were used to calculate stimulation indices (SI).
The irritant potential of the test substance was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- In the positive control group given HCA at the concentration of 25% in AOO, a moderate increase in cellularity and a stimulation index exceeding the threshold positive value of 3 (SI = 12.8) were noted. The study was therefore considered valid.
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- Alkenyl phosphonate 10 (w/v)% in AOO
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- Alkenyl phosphonate 5 (w/v)% in AOO
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- Alkenyl phosphonate 2.5 (w/v)% in AOO
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Alkenyl phosphonate 1 (w/v)% in AOO
- Key result
- Parameter:
- SI
- Value:
- 12.8
- Test group / Remarks:
- Positive control (25 % HCA) in AOO
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: The appearance of the lymph nodes was normal in the negative control group and in all test item treated dose groups. Larger than normal lymph nodes were observed in the positive control group.
EC3 CALCULATION: Not applicable
CLINICAL OBSERVATIONS: No signs of systemic toxicity were observed during the study.
BODY WEIGHTS: No treatment related marked body weight loss (≥5%) was observed on the mean body weight changes of the groups.
Other: No mortality was observed during the study. No test item precipitate was observed on the ears of the experimental animals. Slight erythema was observed (score 1) for all animals of the 10% (w/v) dose group on Days 2-3 and for all animals of the 5% (w/v) dose group on Day 3. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- under the conditions of the present assay, Alkenyl phosphonate, tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay. Therefore, no classification is required according to EU criteria.
- Executive summary:
In a dermal sensitization study using the method of Local Lymph Node assay (LLNA), (CiToxLAB, 2017) with Alkenyl phosphonate in AOO, 9-week CBA/J mice (4 females per group) were tested according to the guideline OECD 429, at the concentrations of 1, 2.5, 5 and 10%. The positive control group received alpha-hexylcinnamaldehyde (25% in AOO).
No mortality and no systemic clinical signs were observed during the study. No test item precipitate was observed on the ears of the experimental animals. Slight erythema was observed (score 1) for all animals of the 10% (w/v) dose group on Days 2-3 and for all animals of the 5% (w/v) dose group on Day 3.
The appearance of the lymph nodes was normal in the negative control group and in all test item treated dose groups. Larger than normal lymph nodes were observed in the positive control group. The stimulation Index Values were 2.0, 1.1, 1.4 and 0.8 at 10%, 5%, 2.5 and 1% Alkenyl phosphonate in AOO respectively.
Under the test conditions of this study, Alkenyl phosphonate is not considered as a skin sensitizer and therefore no classification is required according to EU and UN GHS criteria.
Reference
Table 1: DPM, DPN and Stimulation Index Values for all Groups
Test Group |
Measured |
|
No. of |
|
Stimulation |
Name |
DPM/group |
DPM |
Nodes |
DPN |
Index Values |
Background |
33 |
- |
- |
- |
- |
(5 (w/v) % TCA ) |
|||||
Negative control |
6478 |
6445.0 |
8 |
805.6 |
1.0 |
(in AOO) |
|||||
Alkenyl phosphonate |
13009 |
12976.0 |
8 |
1622.0 |
2.0 |
10 (w/v)% |
|||||
in AOO |
|||||
Alkenyl phosphonate |
7342 |
7309.0 |
8 |
913.6 |
1.1 |
5 (w/v)% |
|||||
in AOO |
|||||
Alkenyl phosphonate |
9369 |
9336.0 |
8 |
1167.0 |
1.4 |
2.5 (w/v)% |
|||||
in AOO |
|||||
Alkenyl phosphonate |
5436 |
5403.0 |
8 |
675.4 |
0.8 |
1 (w/v)% |
|||||
in AOO |
|||||
Positive control |
82721 |
82688.0 |
8 |
10336.0 |
12.8 |
Notes:
1.DPM (Disintegrations Per Minute)
2.DPN (Disintegrations Per Node) = DPM divided by the number of lymph nodes.
3.Stimulation Index = DPN of a treated group divided by DPN of the appropriate control group.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
1- Skin sensitisation:
1 -1 In vitro tests:
Due to the insolubility of the test item, the study OECD 442D was stopped at this stage. Under the experimental conditions of this test and based on the solubility results, the test item was considered incompatible with the design of the study, indeed solubility is a limitation of this protocol. Consequently the potential to activate theNrf2 transcription factor of the test item could not be evaluated with this KeratinoSens test.
As Alkenyl phosphonate is poorly soluble in water and an UVCB, the in vitro methods are not applicable. Therefore, in vivo test is recommended (LLNA test, OECD 429) in order to conclude on the skin sensitization classification for alkenyl phosphonate (ECHA Recommendations, 2016).
1 -2 In vivo Test: LLNA test (OECD 429, Kr.1, GLP):
One study was available and considered as the key study (Kr.1, GLP). In a dermal sensitization study using the method of Local Lymph Node assay (LLNA), with Alkenyl phosphonate in AOO, 9-week CBA/J mice (4 females per group) were tested according to the guideline OECD 429, at the concentrations of 1, 2.5, 5 and 10%.
No mortality and no systemic clinical signs were observed during the study. The stimulation Index Values were 2.0, 1.1, 1.4 and 0.8 at 10%, 5%, 2.5 and 1% Alkenyl phosphonate in AOO respectively. Based on these results, Alkenyl phosphonate was not considered as a skin sensitizer.
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008.
Self classification:
1-Skin sensitisation: based on the results of the key study (OECD 429, Kr.1, GLP), Alkenyl phosphonate is not considered as a skin sensitizer. Therefore, no classification is required according to EU criteria.
2- Respiratory sensitisation: no classification is proposed due to lack of data.
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