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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 04 December 2014 to 09 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’ARBRESLE CEDEX, France.
- Age at arrival: 7 to 8 weeks old
- Weight at arrival: 18 to 20 grams
- Housing: Polysulphone solid bottomed cages measuring 35.5 x 23.5 x 19 cm with nesting material
- Animals per cage: 1/cage during the study; up to 5 during acclimatisation
- Diet (e.g. ad libitum): ad libitum4 RF 21 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C+/-2 °C
- Humidity (%): 55%+/-15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 21 January 2015 To: 09 February 2015
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10% 5% 2.5% (Test Item) 25% (Positive Control)
- No. of animals per dose:
- 4 females
- Details on study design:
- RANGE FINDING TEST:
- Irritation: Animals treated for three consecutive days (Days 1, 2, 3) with 25 µL/ear/day ofthe vehicle or test item formulations at 1, 2.5, 5, 10, 25%:
The treated sites of all animals were examined daily, ear thickness measured by a suitable micrometer on Day 1 (before dosing),
on Day 3 (before dosing) and on Day 6. After sacrifice, regularly shaped biopsies obtained from both ears and weighed together.
Main test:
- No. of exposures:3
- Test groups: 3 with test item, 1 with positive control
- Control groups: 2 (test item negative control and vehicle of positive control )
- Site: Ears, 25 µL/ear/day
- Frequency of applications: once daily
- Duration: 3 days
- Concentrations: 5%, 10%, 25% (Test Item); 25% (Positive control)
- Day 5: intraperitoneal injection of 0.5 mL/animal of a solution of BrdU at a concentration of 10 mg/mL in physiological saline
- Day 6 : Sacrifice, the auricular lymph nodes were excised, pooled on individual basis and individually collected in a solution of 2 % BSA-PBS [2 % bovine serum albumine (BSA) in phosphate buffered saline, PBS]. Cell suspensions were prepared for the evaluation of proliferation .
BrdU was measured by ELISA using a commercial kit (Roche Applied Science, Mannheim, Germany, Catalogue Number 11 647 229 001, batch no. 10493100).
Absorbance (OD) was detected at 450 nm (with reference wavelength: 690 nm).
The BrdU labelling index was calculated for each mouse and a group mean was subsequently calculated. Results for each treatment group were expressed as the mean Stimulation Index (SI). The SI was derived by dividing the mean BrdU labelling index/mouse within each test item
group and the positive control groups by the mean labelling indices for the respective vehicle group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Differences between each treated group and the concurrent negative control group (individual BrdU labelling indices) were assessed by Dunnett’s
test. The homogeneity of the data was verified by Bartlett’s test before Dunnett’s test. If data were found to be inhomogeneous a Modified t test
(Cochran and Cox) was applied.
Results and discussion
- Positive control results:
- In the group treated with the positive control item, a Stimulation Index of 4.37 was calculated. As it was greater than 2, the study was regarded as
valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- low-dose group
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- mid-dose group
- Key result
- Parameter:
- SI
- Value:
- 0.86
- Test group / Remarks:
- high-dose group
Any other information on results incl. tables
Preliminary phase:
Five concentrations (25, 10, 5, 2.5 and 1% w/w) of the test item were selected to be used in the preliminary test. The concentration of 25% was found to be not administrable due to the viscosity of the obtained formulation. No signs of toxicity (clinical signs or toxicologically relevant body weight losses) were observed at any of the tested concentrations. The evaluation of visible reactions showed no erythema at any of the concentrations investigated (10, 5, 2.5 and 1% w/w). The evaluation of ear thickness indicated that no increase was induced by treatment (values of Day 6 compared to Day 1). The evaluation of ear punch weight indicated that an increase, without any dose-relation, was observed in the treated animals ranging from 19 to 24%, when compared to the animals treated with the vehicle. Based on the results described above, the highest concentration selected for the main assay was 10% w/w.
Main assay:
No mortality was recorded in animals treated at all dose levels investigated (10, 5 and 2.5% w/w). Blue staining of the ears was noted in the animals treated with the test item, generally starting from Day 2 up to the end of the observation period. This finding was due to the coloration of the test item.
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
No significant increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated Stimulation Indices (SI) were 0.90, 0.89 and 0.86, respectively at low, mid- and high dose levels.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated Stimulation Indices were 0.90, 0.89 and 0.86 at low, mid- and high dose levels, respectively.
- Executive summary:
Preliminary test
Five concentrations were tested in the preliminary test [25, 10, 5, 2.5 and 1% w/w in acetone:olive oil 4:1 (v/v)] in order to identify a non toxic and minimally irritant concentration and avoid false positive results. Concentration of 25% w/w was found to be not administrable due to the high viscosity. No signs of toxicity (significant clinical signs or body weight losses) were observed at the administered concentrations. According to the results obtained, the concentration of 10% w/w was judged to be not irritant.
Main assay:
In the main assay, the test item was topically administered at the concentrations of 10, 5 and 2.5 w/w in acetone:olive oil 4:1 (v/v).
No mortality nor significant clinical signs were recorded in any animal. Body weight changes were considered not remarkable.
No increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated Stimulation Indices were 0.90, 0.89 and 0.86 at low, mid- and high dose levels, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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