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EC number: 700-910-4 | CAS number: 1354201-99-2
- 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:
- 22 August - 17 September, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Also according to GLP principles.
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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- EC Number:
- 700-910-4
- Cas Number:
- 1354201-99-2
- Molecular formula:
- C11H28NO2PS2
- IUPAC Name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- Test material form:
- solid
- Remarks:
- pale yellow glassy solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): S-10713
- Substance type: Straw color, lump solid
- Physical state: solid
- Lot/batch No.: AQ11216TZ
- Expiration date of the lot/batch: July 2013
- Stability: Stable under normal conditions
- Storage condition of test material: Room temperature; in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9-10 weeks old
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (range 21-24g)
- Housing: Animals were group housed in labeled makrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
Temporary deviations from the minimum and maximum daily mean relative humidity occurred. The study integrity was not adversely affected by the deviations.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 10, 40, 80% w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Two test substance concentrations were tested: 50% and 80% concentration. The highest concentration was the maximum concentration that could technically be applied and that could be prepared homogeneously.
List of protocol deviations:
1. The clinical signs were observed slightly too early on Day 3: at 2 hours and 21 minutes after dosing instead of 3-4 hours after dosing.
Evaluation: Sufficient information was available; the slight deviation in observation time on Day 3 was considered not to have adversely affected the dose level selection.
The study integrity was not adversely affected by the deviations.
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 for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer (according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and the Regulation (EC) No 1272/2008 of the European Parliament
- The EC3 was determined according to Basketter et al: "A comparison of statistical approaches to the derivation of EC3 values from local lymph node assay dose responses", J Appl Toxicol 1999;19:261-266
ANIMAL ASSIGNMENT
Three groups of five animals were treated with one test substance concentration per group. One group of five animals was treated with vehicle.
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance preparation: The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. Homogeneity was obtained to visually acceptable levels.
Rationale for vehicle: The vehicle was selected based on trial formulations performed at WIL Research and on test substance data supplied by the sponsor.
Induction - Days 1, 2 and 3; Excision of nodes - Day 6; Tissue processing for radioacitivity - Day 6; Radioactivity measurements - Day 7; Performed according to test guidelines.
Observations:
Mortality/Viability: Twice daily.
Body weights: On Day 1 (pre-dose) and Day 6 (prior to necropsy).
Clinical signs: Once daily on Days 1-6 (on Days 1-3 between 3 and 4 hours after dosing).
Irritation: Once daily on Days 1-6 (on Days 1 - 3 immediately after dosing) according to the numerical scoring system as descibed in the guideline. Furthermore, a description of all other (local) effects was recorded according to guidelines.
Necropsy: No necropsy was performed according to protocol. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- The results of a reliability test with three concentrations of Hexylcinnamaldehyde in Acetone/Olive oil (4:1 v/v), performed not more than 6 months previously and using the same materials, animal supplier, animal strain and essential procedures was available. For both scientific and animal welfare reasons, no concurrent positive control group was added to the study. An extensive database is available with reliability checks performed each half year during at least the recent 9 years showing reproducible and consistent positive results.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- > 0 - < 10
- Parameter:
- SI
- Value:
- 3.3
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 3.6
- Test group / Remarks:
- 40%
- Parameter:
- SI
- Test group / Remarks:
- 80%
- Remarks on result:
- not determinable
- Remarks:
- Based on the clinical signs, this concentration was not used for interpretation of the sensitization potential
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 032
- Test group / Remarks:
- 20%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 229
- Test group / Remarks:
- 40%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 6 727
- Test group / Remarks:
- 80%
Any other information on results incl. tables
Results Pre-screen test:
Very sight erythema was noted in both animals at 50% and 80% on Days 4 and 5. No signs of systemic toxicity were noted in the animals examined. Variations in ear thickness during the observation period were less than 25% from Day 1 pre-dose values.
Based on these results, the highest test substance concentration selected for the main study was an 80% concentration.
Other results - main study:
Slight irritation of the ears was shown in all animals treated at 40% and 80% between Days 3 and/or 5. One animal at 80% showed slight irritation on Day 2, 4 and 5 and well defined erythema on Day 3. One animal at 10% showed scabs on one ear on Day 4 only. The irritation in these animals was considered not to have a toxicologically significant effect on the activity of the nodes.
The auricular lymph nodes of the animals treated at 10%, 40% or 80% appeared larger in size as compared to the other treated groups. The largest auricular lymph nodes were found in the highest dose group. No macroscopic abnormalities of the surrounding area were noted in any of the animals.
No mortality occurred. No clinical signs of systemic toxicity were observed at 10 and 40% concentration. On Day 3 lethargy, ptosis and abnormal gait were noted in one animal at the 80% concentration. Based on the clinical signs the highest concentration of 80% cannot be used for interpretation of the sensitization potential.
Body
weights and body weight gain of experimental animals at 10 and 40%
remained in the same range as
controls over the study period. One animal at 80% showed very slight
body weight loss.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the results of a LLNA skin sensitisation study, the substance is considered to be a skin sensitiser, as the SI appeared to be ≥ 3 when tested at 10% with and EC3 value < 10% .
- Executive summary:
An LLNA skin sensitisation study was performed according to OECD TG 429 and following GLP prinicples, with three concentrations: 10, 40 and 80%. Slight irritation of the ears was shown in all animals treated at 40% and 80% between Days 3 and/or 5. One animal at 10% showed scabs on one ear on Day 4 only.
The auricular lymph nodes of animals in all dose groups appeared larger in size as compared to the other treated groups. No macroscopic abnormalities of the surrounding area were noted in any of the animals. No mortality or unexpected weight loss occurred at 10 and 40%. Due to observation of clinical signs in the highest dose group (80%), data from these animals were not used for interpretation of the sensitization potential.
The SI values calculated for the substance concentrations 10 and 40% were 3.3 and 3.6 respectively, the EC3 value (the estimated test substance concentration that will give an SI =3) was established to be between 0 and 10%. Based on these results, the test material has to be regarded as a skin sensitizer.
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