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EC number: 224-632-3 | CAS number: 4432-31-9
- 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
In a GLP-study according to OECD TG 429 (Local Lymph Node Assay), the substance did not induce any adverse effects and is therefore considered to be not skin sensitising (7.4.1 -1). The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form (CAS 4432-31-9).
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:
- 2016-09-14 to 2016-09-21
- 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)
- Version / remarks:
- 2010
- Deviations:
- yes
- Remarks:
- Deviation in sample preparation without any presumed effect on the study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012
- Deviations:
- yes
- Remarks:
- Deviation in sample preparation without any presumed effect on the study
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 17.9 - 21.0 g
- Fasting period before study: unknown
- Housing: group caging (4 mice/cage), Type II. Polypropylene / polycarbonate
- Diet: ad libitum, ssniff® Rat/Souris-Elevage E complete diet for rats and mice
- Water: ad libitum, tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): not available
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- other: Pluronic
- Concentration:
- 2.5, 5, 10%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: yes (using seven recommended solvents)
- Irritation: no irritation was observed for the three concentration 2.5, 5 and 10% in a preliminary test
- Systemic toxicity: no toxicity was observed for the three concentration 2.5, 5 and 10% in a preliminary test
- Ear thickness measurements: no changes in ear thickness were observed for the three concentration 2.5, 5 and 10% in a preliminary test
- Erythema scores: all 0 for all concentrations, mice and time points (days 1, 2, 3, 4, 5, 6)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: animals were assigned randomly achieving body weight homogeneity between groups
- Criteria used to consider a positive response: stimulation index of one concentration > 3
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of the three respective formulations (substance dissovled in Pluronic) were applied to the dorsal surface of each ear using a pipette - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- none
- Positive control results:
- Stimulation index (SI) of (w/v) hexyl cinnamic aldehyde: 6.7
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 2.3
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Disintegration per minute (per mouse (average)):
vehicle control: 772.8
2.5%: 513.0
5%: 1759.3
10%: 894.5
DETAILS ON STIMULATION INDEX CALCULATION: ratio of DPM/mouse of test concentrations and vehicle control
EC3 CALCULATION: not applicable
CLINICAL OBSERVATIONS: no irritation or other effects observed
BODY WEIGHTS: no treatment related effects - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present assay, the test item at the maximum feasible concentration of 10 % and also at concentrations of 5 % or 2.5 % (w/v) was shown to have no skin sensitization potential in the Local Lymph Node Assay.
- Executive summary:
A study according OECD TG 429 was performed to evaluate the skin sensitising potential of the test item. A formulation evaluation and a Dose Range Finding test (DRF) were performed to find an appropriate vehicle and the maximum applicable concentration according to the relevant guidelines. Solubility of the test item in vehicles preferred in the LLNA was evaluated and concentration series of 100 %, 50 %, 25 %, 10 % etc. were used. The maximum attainable concentration (based on solubility) was 10 % (w/v) in aqueous 1 % (w/v) Pluronic®PE 9200 (Plu). According to results of the DRF, where no adverse effect was observed up to this maximum concentration, the test item was examined in the main test as 10 %, 5 % or 2.5 % (w/v) formulations in the selected vehicle of Plu. Appropriate positive control (alpha-Hexylcinnamaldehyde, HCA), furthermore two negative control groups dosed with the vehicles of the test and positive control groups, respectively, were employed. The positive control item (25 % (w/v) HCA in Acetone:Olive oil 4:1 (v/v) mixture, AOO) induced significant stimulation over the relevant control (SI = 6.7) thus confirming the validity of the assay. No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group. No significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the relevant control (Plu) was noted for the test item at the applied test concentrations. The observed stimulation index values were 1.2, 2.3 and 1.7 at test item concentrations of 10 %, 5 % and 2.5 % (w/v), respectively. No significant dose-response relationship was observed. Accordingly, the substance was considered to be not a skin sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study according OECD TG 429 was performed to evaluate the skin sensitising potential of the test item. A formulation evaluation and a Dose Range Finding test (DRF) were performed to find an appropriate vehicle and the maximum applicable concentration according to the relevant guidelines. Solubility of the test item in vehicles preferred in the LLNA was evaluated and concentration series of 100 %, 50 %, 25 %, 10 % etc. were used. The maximum attainable concentration (based on solubility) was 10 % (w/v) in aqueous 1 % (w/v) Pluronic®PE 9200 (Plu). According to results of the DRF, where no adverse effect was observed up to this maximum concentration, the test item was examined in the main test as 10 %, 5 % or 2.5 % (w/v) formulations in the selected vehicle of Plu. Appropriate positive control (alpha-Hexylcinnamaldehyde, HCA), furthermore two negative control groups dosed with the vehicles of the test and positive control groups, respectively, were employed. The positive control item (25 % (w/v) HCA in Acetone:Olive oil 4:1 (v/v) mixture, AOO) induced significant stimulation over the relevant control (SI = 6.7) thus confirming the validity of the assay. No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group. No significantly increased lymphoproliferation (indicated by an SI ≥ 3) compared to the relevant control (Plu) was noted for the test item at the applied test concentrations. The observed stimulation index values were 1.2, 2.3 and 1.7 at test item concentrations of 10 %, 5 % and 2.5 % (w/v), respectively. No significant dose-response relationship was observed. Accordingly, the substance was considered to be not a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.
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