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EC number: 856-663-9 | CAS number: 2400970-89-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 October 2020 thru 10 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts
- Molecular formula:
- C33H66N3S6Sb to C51H102N3S6Sb
- IUPAC Name:
- Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- PYSICAL DESCRIPTION: Highly viscous amber liquid.
PURITY: >99%
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: WT05-19
- Expiration date of the lot/batch: not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp.
- Stability under storage conditions: stable for the duration of testing.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Received from Envigo RMS Inc. on October 14, 2020 (Preliminary Irritation Group Animals) and on October 14 and 21, 2020 (Test and Control Group Animals)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Preliminary Animals: Young adult (11 weeks); Test and Control Animals: Young adult (11-12 weeks)
- Weight at study initiation: 18.8 - 22.9 grams
- Housing: All caging conformed to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011)
- Diet (e.g. ad libitum): Envigo Teklad Global 16% Protein Rodent Diet® #2016. The diet was available ad libitum.
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period: 14 or 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%):53 - 66
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12
- IN-LIFE DATES: From: To: 28 October 2020 thru 10 November 2020
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10%, 25% and 50%
- No. of animals per dose:
- Preliminary Irritation (4 groups): 2 per group
Test (3 groups): 5 per group
Vehicle (Negative) Control: 5
Positive Control: 5 - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Solubility testing indicated that the test substance was soluble in Acetone/Olive Oil (4:1 v/v)
- Irritation: None at any dose
- Systemic toxicity: None at any dose
- Erythema scores: Draize method
MAIN STUDY
Criteria used to consider a positive response: The mean and standard deviation of the dpm values were calculated for each dose group. A stimulation index (SI) was derived for each experimental group by dividing the mean dpm of each experimental group by the mean dpm of the vehicle control group. Any test substance that produces an SI > 3 in the LLNA is normally considered “positive” for dermal sensitization potential (Kimber et al., 1994). All calculations were performed on the DPM minus background values. The EC3 value was not calculated since all dose levels induced a stimulation index of less than 3.0.
TREATMENT PREPARATION AND ADMINISTRATION:
Concentrations of 10%, 25% and 50% were selected for the main test based on results of the preliminary screening test. Dilutions of the test substance were prepared as w/w mixtures in Acetone/Olive Oil (4:1 v/v; AOO). The vehicle control, AOO, and a single concentration of a 25% w/w mixture of HCA in AOO were also prepared. All dosage preparations were freshly prepared on the day of application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical analysis was performed on the DPM minus background values. Significance was judged at p < 0.05. The treated groups and negative vehicle control group were compared using a One-Way Analysis of Variance (ANOVA), followed by comparison of the treated groups to control by Dunnett’s t-test for multiple comparisons. Where variances are considered significantly different by Bartlett’s test, groups were compared using a non-parametric method (Kruskal-Wallis non parametric analysis of variance followed by Dunn’s test) (INSTAT Biostatistics, Graph Pad Software, San Diego, CA). Outlier analysis was conducted using Grubbs (1969).
Results and discussion
- Positive control results:
- Very slight erythema (score of 1) was evident at four positive control sites on Day 3. Desquamation was present at two sites on Days 3 and 6.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks:
- 10% Concentration
- Value:
- 0.74
- Key result
- Parameter:
- SI
- Remarks:
- 25% Concentration
- Value:
- 0.57
- Key result
- Parameter:
- SI
- Remarks:
- 50% Concentration
- Value:
- 0.96
- Cellular proliferation data / Observations:
- EC3 CALCULATION
: Not calculated since all dose levels induced a stimulation index of less than 3.0
CLINICAL OBSERVATIONS: All animals were active and healthy throughout the study.
BODY WEIGHTS: Two mice each from the vehicle control and positive control groups and six from the test groups lost or failed to gain body weight during the study. All other mice gained body weight during the study.
DERMAL IRRITATION: For the high dose group only, very slight erythema (score of 1) was evident at one test site on Day 2 and at three sites on Day 3.
Any other information on results incl. tables
Group |
Mean DPM minus background |
SI |
Sensitization Response |
|
Vehicle Control |
1 |
3034.91 |
- |
N/A |
Positive Control (25% HCA) |
2 |
11737.68 |
3.87 |
Positive – valid study |
10% Test Substance |
3 |
2233.63 |
0.74 |
Not a Sensitizer |
25% Test Substance |
4 |
1727.84 |
0.57 |
Not a Sensitizer |
50% Test Substance |
5 |
2905.09 |
0.96 |
Not a Sensitizer |
Group 5 - 50% Test Substance In AOO: Erythema/Edema Scores
Animal No. |
Sex |
Days |
|||||||
1 |
2 |
3 |
6 |
||||||
Left |
Right |
Left |
Right |
Left |
Right |
Left |
Right |
||
3621 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
1/0 |
1/0 |
0/0 |
0/0 |
3622 |
F |
0/0 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3623 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3624 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3625 |
F |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not considered to be a contact dermal sensitizer at concentrations less than or equal to 50% in the mouse Local Lymph Node Assay (LLNA).
- Executive summary:
In an in vivo Local Lymph Node Assay (LLNA) conducted in accordance with EU Method B.42 under GLP conditions with mice, test substance was not considered to be a contact dermal sensitizer at concentrations less than or equal to 50%. All animals were active and healthy throughout the study. Two mice each from the vehicle control and positive control groups and six from the test groups lost or failed to gain body weight during the study. All other mice gained body weight during the study. For the high dose group only, very slight erythema (score of 1) was evident at one test site on Day 2 and at three sites on Day 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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