Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 216-600-2 | CAS number: 1623-05-8
- 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:
- 2014
- 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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Deviations from the maximum daily mean relative humidity occurred. Lab historical data do not indicate an effect of the deviations.
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- MTDID 16437
- IUPAC Name:
- MTDID 16437
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 16437
- Substance type: Mono constituent
- Physical state: Liquid
- Analytical purity: 98.5%
- Purity test date: 04/08/2014
- Lot/batch No.: 114B1005
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: At room temperature in the dark under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: 19-23 grams
- Housing: Group housed in labeled Makrolon cages (MIII type; height 18 cm) containing sterilized sawdust as bedding. Paper and shelters were supplied as cage enrichment.
- 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): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 July 2014 To: 28 July 2014
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 0 (control), 10, 30, or 100% w/w test article in methyl ethyl ketone.
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Soluble in vehicle
- Irritation: No irritation observed (variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values).
- Lymph node proliferation response: Not performed in the pre-screen.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: DPM values are presented for each animal and each dose group. A Stimulation Index (SI) is calculated from each group using the individual SI values. The individual SI is the ratio of the DPM/animal compared to the DPM/vehicle control group. If the results indicated a SI greater than or equal to 3, the test substance may be regarded as a skin sensitizer. Consideration was given to the EC3 value (the estimated test substance concentration that will give a SI=3).
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears of each mouse was topically treated (25 uL/ear) with the test substance concentration, at approximately the same time each day from study Days 1 through 3. The control animals were treated in the same way as the experimental animals with the vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A positive control reliability check with Alpha-hexylcinnamaldehyde is conducted every six months.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the subtance concentrations 10, 30 and 100% were 1.4, 1.5 and 1.5, respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 30 and 100% were 351, 395 and 396 DPM, respectively. The mean DPM/animal value for the vehicle control group was 258 DPM.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test article did not show evidence of dermal sensitization potential.
- Executive summary:
The dermal sensitization potential of the test article (Clear colorless liquid, purity 98.5%, Batch 114B1005) was evaluated in the local lymph node assay (LLNA) with female CBA/J strain mice. The study was performed in compliance with OECD GLP ENV/MC/CHEM (98) 17 (revised 1997). The test method was based on OECD No. 429 (2010). The test article was prepared in methyl ethyl ketone. A pre-screen test was conducted to select test article concentrations of 10%, 30% and 100%. Female mice (4/treatment) received the negative control (methyl ethyl ketone), 10%, 30%, or 100% concentrations of the test substance. The corresponding treatment (25 uL/ear) was applied to the dorsal surface of both ears for three consecutive days. Three days after the last exposure (Day 6), all animals were injected with 0.25 mL sterile phosphate buffered saline containing 3 H-methyl thymidine and subsequently euthanized. The nodes were pooled for each animal, and lymphocyte proliferation was determined by measuring disintegrations per minute (DPM). The stimulation index (SI) was calculated for each group. Observations for mortality (once daily), body weights (Day 1 and Day 6), clinical signs (once daily), ear thickness (Days 1-3, and Day 6), and irritation (Days 1-3 and 6) were performed as well. A six-month reliability check with Alpha-hexyl cinnamaldehyde is performed to ensure that the model is appropriate for testing contact hypersensitivity. Mean DPM/node values for the 10%, 30%, and 100% test article concentrations were 351, 395, and 396 DPM respectively. The negative control mean DPM/node value was 258 DPM. The SI values for test concentrations of 10%, 30%, and 100% were 1.4, 1.5, and 1.5 respectively. No EC3 value was calculated because all SI values were < 3. The positive control SI was >3 so the test method was considered valid. No irritation of the ears was observed in any animal. No mortality, clinical signs of toxicity, or significant body weight changes were observed. Based on the results of the study, the test article did not show evidence of dermal sensitization potential.
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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