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EC number: 272-902-4 | CAS number: 68919-76-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-07-16 to 2012-11-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD guideline 429 and EU method B.42 in a GLP-certified testing facility
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- (During the second and the fourth pre-test and during the acclimation phase of the main test, the relative humidity in the animal room was >95 % instead of 45 - 65 % for several hours due to cleaning and disinfection work in the animal house.)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- (During the second and the fourth pre-test and during the acclimation phase of the main test, the relative humidity in the animal room was >95 % instead of 45 - 65 % for several hours due to cleaning and disinfection work in the animal house.)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- other: liquid
- Details on test material:
- Internal Test Item Number: S1353211
Identity: 400112
Batch No.: 0001273679
Purity: 100%
Storage: At room temperature
Expiration Date: May 01, 2013
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.05 %
0.1 %
0.25 % - No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: soluble in acetone/olive oil
- Irritation: yes, at concentrations > 1%
- Systemic toxicity:
- Ear thickness measurements: yes
- Erythema scores: yes
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control
- Key result
- Parameter:
- SI
- Value:
- 1.37
- Test group / Remarks:
- 0.05%
- Key result
- Parameter:
- SI
- Value:
- 1.53
- Test group / Remarks:
- 0.1%
- Key result
- Parameter:
- SI
- Value:
- 2
- Test group / Remarks:
- 0.25%
Any other information on results incl. tables
Viability / mortality
No deaths occurred during the study period.
Clinical signs
No systemic findings were observed during the study period. On days 3 and 4, the animals treated with a test item concentration of 0.1% showed an erythema of the ear skin (score: 1). On days 3-6, the animals treated with the high dose showed an erythema of the ear skin as well (score: 1 on days 5 and 6, score: 2 on days 3 and 4).
Body weights
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising according to EU regulation
- Conclusions:
- The test item 400112 was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In order to study a possible skin sensitising potential of 400112, three groups each of four female mice were treated once daily with the test item at concentrations of 0.05, 0.1 and 0.25% (w/w) in acetone:olive oil (4:1; v/v) by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by four pre-experiments. A control group of four mice was treated with the vehicle (acetone:olive oil (4:1; v/v)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately 5 h after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
All treated animals survived the scheduled study period and no signs of systemic toxicity were observed. On days 3 and 4, the animals treated with a test item concentration of 0.1% showed an erythema of the ear skin (score: 1). On days 3-6, the animals treated with the high dose showed an erythema of the ear skin as well (score: 1 on days 5 and 6, score: 2 on days 3 and 4).
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 1.37, 1.53 and 2.0 were determined with the test item at concentrations of 0.05, 0.1 and 0.25% (w/w) in acetone:olive oil (4 :1; v/v). A clear dose response was observed.
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
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.
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