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EC number: 236-291-8 | CAS number: 13282-70-7
- 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
One valid study is available for the test item NDPSa (Cas n.: 13282-70-7,other identifier: H-31339).
GHS Cat. 1; LLNA in mice; OECD TG 429; E.L. Wilkinson (2015)
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: 2014-11-11 To: 2015-01-20
- 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
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- CBA/JHsd mice
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Harlan Sprague Dawley, Frederick, Maryland, U.S.A.
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Microbiological status of animals, when known:Water samples are analyzed for total bacterial counts, and the presence of coliforms, lead, and other contaminants. Samples from freshly washed cages and cage racks are analyzed to ensure adequate sanitation by the cagewashers.
- Age at study initiation: 9 weeks old.
- Weight at study initiation: between 19.8 and 21.5 grams.
- Housing: solid-bottom cages with appropriate bedding and nestlets toys as enrichment.
- Diet (e.g. ad libitum): PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 ad libitum.
- Water (e.g. ad libitum): tap water ad libitum.
- Acclimation period:quarantined for 8 days.
- Indication of any skin lesions: none.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.
- IN-LIFE DATES: From: 12 November 2014 To: 17 November 2014 - Vehicle:
- propylene glycol
- Concentration:
- The 70% concentration, prepared in propylene glycol, was chosen as the high dose based on solubility testing. (insoluble) Hence, concentrations greater than 70% were not evaluated.
- No. of animals per dose:
- All females.
Group 1 : 6
Group 2: 5
Group 3: 5
Group 4: 5
Group 5: 5
Group 6: 6 - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility:Due to insolubility of the test substance, concentrations greater than 70% were not evaluated.
MAIN STUDY
Five groups of 5 or
6 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle), 5%, 25%, 50%, or 70% H-31339 on both ears. Propylene glycol (PG) was used as the diluting vehicle. One group of 6 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in PG as a positive control. On test day 6 of the assay, mice received 3H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance groups was then evaluated and compared to the vehicle group.
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:Statistically significant increases in cell proliferation measurements compared to the vehicle group were observed at all test concentrations of H-31339. Stimulation indices (SIs) of greater than 3.0 were observed at all test concentrations of H-31339. The EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was calculated to be 0.6%. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with H-31339.
TREATMENT PREPARATION AND ADMINISTRATION:Twenty-five μL of vehicle, test substance preparation, or positive control were administered topically to the dorsum of each mouse ear for 3 consecutive days (test days 1-3) at concentrations listed in the Study Design. Test days 4-5 were days of rest followed by intravenous injection of 20 μCi of 3H-thymidine in PBS per mouse on test day 6. Two mice (359 in the 25% test substance group and 558 in the 70% test substance group) were not injected with the appropriate amount of radioactive material and the lymph nodes for these mice were analyzed but not reported. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Significance was judged at p < 0.01. Lymph node dpm data were transformed to Log to obtain normality or homogenous variances.
- Positive control results:
- The positive control, hexylcinnamaldehyde (HCA), was purchased commercially. Any available information on the positive control was included in the study records. Impurities in the positive control were not expected to interfere with the study results. The positive control appeared to be stable under the conditions of the study. No evidence of instability, such as a change in color or physical state, was observed.
A 25% HCA solution in the vehicle was blended using a vortex mixer and stored in a vial protected from light until dosing was completed. - Key result
- Parameter:
- SI
- Value:
- 0
- Variability:
- threshold positive response
- Test group / Remarks:
- 1
- Key result
- Parameter:
- SI
- Value:
- 19.98
- Variability:
- threshold positive response
- Test group / Remarks:
- 2
- Key result
- Parameter:
- SI
- Value:
- 32.71
- Variability:
- threshold positive response
- Test group / Remarks:
- 3
- Key result
- Parameter:
- SI
- Value:
- 28.57
- Variability:
- threshold positive response
- Test group / Remarks:
- 4
- Key result
- Parameter:
- SI
- Value:
- 21.37
- Variability:
- threshold positive response
- Test group / Remarks:
- 5
- Key result
- Parameter:
- SI
- Value:
- 9.74
- Variability:
- threshold positive response
- Test group / Remarks:
- 6
- Cellular proliferation data / Observations:
- Statistically significant increases in cell proliferation measurements compared to the vehicle group were observed at all test concentrations of H-31339. Stimulation indices (SIs) of greater than 3.0 were observed at all test concentrations of H-31339. The EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was calculated to be 0.6%. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with H-31339. Under the conditions of this study, H-31339 produced a dermal sensitization response in mice.
Category EC3 Value (%)
Extreme <0.1
Strong ≥ 0.1 - <1
Moderate ≥1 - <10
Weak ≥10 - ≤ 100
CLINICAL OBSERVATIONS: Careful clinical observations were performed on test day 1, prior to each dose (at approximately the same time ± 2 hours) on test day 2 and 3, and on the day of sacrifice.
BODY WEIGHTS: No biologically relevant changes in body weights were observed at any test concentration.
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness).
No clinical signs of toxicity were observed in the study. - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on these data, and according to the guidance provided by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), H-31339 is considered a strong dermal sensitizer in mice.
- Executive summary:
The objective of this study was to evaluate the potential of H-31339 to produce a dermal sensitization response in mice using the local lymph node assay (LLNA). Five groups of 5 or 6 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle), 5%, 25%, 50%, or 70% H-31339 on both ears. Propylene glycol (PG) was used as the diluting vehicle. One group of 6 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in PG as a positive control. On test day 6 of the assay, mice received 3H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance groups was then evaluated and compared to the vehicle group.
No biologically relevant changes in body weights were observed at any test concentration. No clinical signs of toxicity were observed in the study.
Statistically significant increases in cell proliferation measurements compared to the vehicle group were observed at all test concentrations of H-31339. Stimulation indices (SIs) of greater than 3.0 were observed at all test concentrations of H-31339. The EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was calculated to be 0.6%. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with H-31339. Under the conditions of this study, H-31339 produced a dermal sensitization response in mice.
Based on these data, and according to the guidance provided by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), H-31339 is considered a strong dermal sensitizer in mice.
Reference
Stimulation Index Data
Group | Material Tested | n | Mean (dpm) | S.D. (dpm) | SI |
1 | 0 % Vehicle | 6 | 717.92 | 163.58 | n/a |
2 | 5 % | 5 | 14341.45 # | 2684.63 | 19.98 |
3 | 25 % | 4b | 23481.00 # | 7188.52 | 32.71 |
4 | 50 % | 5c | 20513.45 # | 10008.19 | 28.57 |
5 | 70 % | 4b | 15345.00 # | 2911.64 | 21.37 |
6 | 25 % Positive Control | 6 | 6992.58 | 2073.54 | 9.74 |
a Data were not included in the statistical analysis of the test substance groups.
b One mouse was not injected with the appropriate amount of radioactive material and the lymph nodes for this mouse were not analysed.
c The dpm value for one mouse was deemed an outlier by statistical analysis; however, the dpm data for this mouse were included in the statistical analysis. The group mean calculated stimulation index remained >3.0 whether the outlier was included or excluded in the calculation; therefore, the data were reported.
# Statistically significant increase in dpm data from vehicle at p < 0.01 by Jonckheere-Terpstra trend test.
* Statistically significant increase in dpm data from vehicle at p < 0.01 by Dunnett/Tamhane-Dunnett test.
@ Statistically significant increase in dpm data from vehicle at p < 0.01 by Dunn's test.
~ Due to lack of control group values or variability among group means, statistical analyses were unable to be performed.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
LLNA skin sensitisation:
The objective of this study was to evaluate the potential of H-31339 to produce a dermal sensitization response in mice using the local lymph node assay (LLNA). Five groups of 5 or 6 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle), 5%, 25%, 50%, or 70% H-31339 on both ears. Propylene glycol (PG) was used as the diluting vehicle. One group of 6 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in PG as a positive control. On test day 6 of the assay, mice received 3H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance groups was then evaluated and compared to the vehicle group.
No biologically relevant changes in body weights were observed at any test concentration. No clinical signs of toxicity were observed in the study.
Statistically significant increases in cell proliferation measurements compared to the vehicle group were observed at all test concentrations of H-31339. Stimulation indices (SIs) of greater than 3.0 were observed at all test concentrations of H-31339. The EC3 value (the estimated concentration required to induce a threshold positive response, i.e., SI = 3) for the test substance under the conditions of this study was calculated to be 0.6%. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with H-31339. Under the conditions of this study, H-31339 produced a dermal sensitization response in mice.
Based on these data, and according to the guidance provided by the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), H-31339 is considered a strong dermal sensitizer in mice.
Justification for selection of Skin sensitisation toxicity endpoint -
one key 1 study usedHarmonised classification:
The substance has harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information on test item, self-classification is proposed according to the CLP or GHS.
GHS 1.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Due to the results of the LLNA toxicity study, with a conclusive outcome of being a strong dermal sensitizer, a classification is justified for category GHS 1.
This classification has been selected on the adverse effects outcome of the key 1 study report.
GHS Category 1
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