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EC number: 249-707-8 | CAS number: 29590-42-9
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP (1997) regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- MTDID 7819CE
- IUPAC Name:
- MTDID 7819CE
- Reference substance name:
- MTDID 7819LS
- IUPAC Name:
- MTDID 7819LS
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 7819 CE, MTDID 7819LS
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 7819CE: 99.61%, 7819LS: 98.79%
- Purity test date: MTDID 7819CE and MTDID 7819LS: 24 Sept, 2015
- Lot/batch No.: MTDID 7819CE:
- Expiration date of the lot/batch: MTDID 7819CE and MTDID 7819LS: 30 November 2016
- Storage condition of test material: At room temperature.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other:
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janier, Le Genest-Sint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: 18.7-23.4 grams
- Housing: Animals were group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilized sawdust as bedding
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest, Germany) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 November 2015 To: 07 December 2015
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0 (control), 25, 50, or 100% w/w test article
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Soluble in vehicle
- Irritation: At 100% test article, less than 25% increase in ear thickness was observed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: If the results indicate a Stimulation Index (SI) or greater than or equal to 3, the test article may be regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears of each animal was topically treated (25 uL/ear) with the appropriate test article concentration (0, 25, 50, or 100%), at the same time on Days 1, 2, and 3. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value (the estimated test article concentration that will yield a SI=3) was determined if possible, using linear interpolation.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: MTDID 7819CE: 25%: 2.8, 50%: 5.0, 100%: 6.0 MTDID 7819LS: 25%: 3.6, 50%: 3.6, 100%: 9.6 Positive Control animals: 4.7
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: MTDID 7819CE: 25%: 2382, 50%: 4320, 100%: 5116 MTDID 7819LS: 25%: 3061, 50%: 3104, 100%: 8253 Vehicle Control animals: 857 Positive Control animals: 4042
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test article shoud be considered to be a skin sensitizer, and the weight of evidence indicates that classification as GHS Category 1B is appropriate.
- Executive summary:
The skin sensitization potential of two samples of CASRN 29590-42-9 (MTDID 7819CE and MTDID 7819LS) was evaluated in a local lymph node assay per OECD 429 and OECD GLP (1997). Based on the results of a pre-screen test, test article concentrations of 25, 50, and 100% were tested in the main test (vehicle: acetone:olive oil 4:1), along with a concurrent positive control (25% alpha-hexylcinnamaldehyde in acetone:olive oil). The dorsal surface of both ears of female mice (5/group) were topically treated (25 uL/ear) with the appropriate test article concentration (0, 25, 50, or 100%), at the same time on Days 1, 2, and 3. Three days after the final exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintigrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. The stimulation indices of MTDID 7819CE at the three concentrations were 2.8, 5.0, and 6.0, and the EC3 was determined to be 27.3%. The stimulation indices of MTDID 7819LS at the three concentrations were 3.6, 3.6, and 9.6; an EC3 could not be determined, because all stimulation indices were >3. The stimulation index of the concurrent positive control was 4.7, which is very similar to the stimulation indices of the positive controls for the other two portions of this study (4.6 and 6.5), in which other acrylate monomers were tested. Based on the results of the study, the test article should be considered to be a skin sensitizer, and the weight of evidence indicates that classification as GHS Category 1B is appropriate.
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