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EC number: 938-829-3 | CAS number: 936103-10-5
- 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
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:
- From 6 October 2014 to 15 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well described study performed according to OECD guideline and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- 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)
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ELEVAGE JANVIER, Route des Chènes Secs B.P. 4105, 53940 LE GENEST-ST-ISLE, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: 20.1-21.6 g
- Housing: Group caging (Cage type: Type II. polypropylene / polycarbonate)
- Diet: ssniff® SM Rat/Mouse – “Breeding & Maintenance, 15 mm, autoclavable Complete diet for rats/mice” produced by ssniff Spezialdiäten GmbH (Ferdinand-Gabriel-Weg 16, D-59494 Soest, Germany), ad libitum.
- Water: tap water from the municipal supply from 500 mL bottle, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.8-25.0°C
- Humidity: 31-70 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: light 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 16 October 2014 To: 27 October 2014 - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25, 10 and 5% (w/v)
- No. of animals per dose:
- 4 female mice
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: based on the results of the preliminary solubility / compatibility test, the test item was formulated in Dimethyl sulfoxide. The highest achievable concentration was 25% (w/v).
- Irritation: the Preliminary Irritation / Toxicity Test was performed in CBA/J Rj mice using two doses (25 and 10% (w/v) in DMSO). Based on the observations recorded in the preliminary test, 25% (w/v) was selected as top dose for the main test.
- Lymph node proliferation response: not measured
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: randomisation
- Criteria used to consider a positive response:
The test item is regarded as a sensitizer if both of the following criteria are fulfilled:
1) That 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) The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
In the main assay, twenty female CBA/J Rj mice were allocated to five groups of four animals each:
- three groups received R0056895A (formulated in DMSO) at 25, 10 and 5% (w/v) concentrations,
- the negative control group received the vehicle (DMSO),
- the positive control group received 25% (w/v) HCA (dissolved in DMSO).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 μL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. On Day 6, 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)
- Positive control results:
- No mortality, cutaneous reactions or signs of toxicity were observed for the positive control substance in the study. A significant lymphoproliferative response (stimulation index value of 5.8) was noted for HCA in the main experiment. The DPN values observed for the positive control substance in this experiment were within the historical control range.
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 1.2, 1.4 and 2.1 at concentrations of 25, 10 and 5% (w/v), respectively. See table below.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table below
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- R0056895A, tested at up to 25% in DMSO, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
- Executive summary:
The skin sensitisation potential of R0056895A was tested in a Local Lymph Node Assay in mice according to OECD Guidelines No. 429 annd Commission Regulation (EC) No 440/2008, B.42. CBA/J Rj mice received CBA/J Rj mice at 25, 10 and 5% (w/v) in DMSO.
No mortality or signs of systemic toxicity were observed during the study. No treatment related body weight loss was observed in the test item treated animals.
The stimulation index values were 1.2, 1.4 and 2.1 at concentrations of 25, 10 and 5% (w/v), respectively. A significant lymphoproliferative response (stimulation index value of 5.8) was noted for the positive control chemical, this result confirmed the validity of the assay.
In conclusion, under the conditions of the assay, R0056895A was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
Reference
Clinical signs:
No mortality or signs of systemic toxicity were observed during the study. Test item precipitate (in the 25% and 10% dose groups) / minimal amount of test item precipitate (in the 5% dose group) was observed on the ears of the animals in all test item treated groups on Days 1-3. There were no indications of any irritancy at the site of application.
Body weight:
No treatment related effects were observed on body weights.
Ear thickness measurement:
Increased ear thickness values were recorded for several test item treated animals on Day 3 and/or Day 6, but none of these values were above the regulatory threshold of 25% (as limit of positivity). The biopsy weights were within the historical control range for all test item treated animals.
Increased ear thickness values (over the limit of positivity) were detected for positive control animals on Day 6, although the biopsy weights were in the historical control range in the positive control group.
Proliferation assay:
Table 1: DPM, DPN and Stimulation Index Values for all Groups
Test Group Name |
Measured DPM / group |
DPM |
Number |
DPN |
Stimulation Index |
Background |
30 |
- |
- |
- |
- |
Negative (vehicle) control |
3846 |
3815.0 |
8 |
476.9 |
1.0 |
R0056895A |
4511 |
4480.0 |
8 |
560.0 |
1.2 |
R0056895A |
5192 |
5161.0 |
8 |
645.1 |
1.4 |
R0056895A |
7974 |
7943.0 |
8 |
992.9 |
2.1 |
Positive control (25% (w/v) HCA in DMSO) |
21984 |
21953.0 |
8 |
2744.1 |
5.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of R0056895A was tested in a Local Lymph Node Assay in mice according to OECD Guidelines No. 429 annd Commission Regulation (EC) No 440/2008, B.42. CBA/J Rj mice received CBA/J Rj mice at 25, 10 and 5% (w/v) in DMSO.
No mortality or signs of systemic toxicity were observed during the study. No treatment related body weight loss was observed in the test item treated animals.
The stimulation index values were 1.2, 1.4 and 2.1 at concentrations of 25, 10 and 5% (w/v), respectively. A significant lymphoproliferative response (stimulation index value of 5.8) was noted for the positive control chemical, this result confirmed the validity of the assay.
In conclusion, under the conditions of the assay, R0056895A was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
Migrated from Short description of key information:
LLNA: not sensitising (SI ≤ 2.1)
Justification for selection of skin sensitisation endpoint:
Only one study, well described and performed according to OECD guideline and GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP criteria and based on the study available (LLNA with SI ≤ 2.1), R0056895A is not classified for skin sensitisation.
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