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EC number: 264-705-7 | CAS number: 64147-40-6
- 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 vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 December 2012 until 14 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to respective guidelines and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: At the time of this report, no adopted national or international guidelines for the in vitro sensitisation test battery evaluation nor the individual tests were available. However, the individual studies were performed according published methodology.
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Chemical reactivity has been shown to be well associated with the allergenic potency. Within this context measuring the amount of proteins with nucleophillic side chains sich as cysteine or lysine residues after incubation with putative allergens may serve as surrogate markers. Due to the complexity of the skin sensitisation process a single in vitro assay is not sufficient to address this endpoint. Therefore a combination of several methods addressing two majore steps of the sensitisation process: protein reactivity and activation of dendritic cells has been proposed in a strategy to assess the sensitising potential.
The test substance was incubated with synthetic peptides for 24 hours at room temperature and the remaining non-depleted peptide concentration was determined by high performance liquid chromatography (HPLC) with gradient elution and UV detection at 220nm. The peptides are custom-made material containing phenylalanine to facilitate UV-detection and either cysteine or lysine as the reactive center. Based on the molecular weight of the test subtance and the peptides, the test substance should be incubated with the C-containing peptide in a ratio of 1:10 (0.5nM peptide, 5 nM test substance) and with the K-containing peptide in a ratio of 1:50 (0.5 nM peptide, 25nM test substance). However, as no molecular weight of the test substance was available a gravimetric procedure was applied. The test substance was dissolved in propanol at a concentration of 3.76% (corresponding to 100nM at a theoretical molecular weight of ca. 375 g/mol and a purity of 100%). Three samples of the test substance were incubated with each peptide in ratios of 1:5 (0.376 mg peptide, 1.88 mg test substance; for C-peptide0 or 1:24 (0.389 mg peptide, 9.4 mg test substance; for K-peptide) based on absolute mass. Additionally triplicates of the concurrent vehicle control (=NC) were incubated with the peptides. Further, a co-elution control was performed in order to detect possible interference of the test
substance with the peptides. The samples consisted of the test substance, vehicle and the respective peptide buffer but without peptide. Moreover the samples were additionally analyzed by measuring UV absorbance at 258 nm and the area ratio 220 / 258 was calculated as a measure of peak purity. The peptide depletion of test-substance incubated samples was compared to the peptide depletion of the NC samples and expressed as relative peptide depletion.
For the test substance the mean peptide depletion as average of C- and K-peptide depletion is calculated and used for evaluation of the chemical reactivity. - GLP compliance:
- yes
- Type of study:
- other: Reactivity of the test substance towards synthetic cysteine (C) or lysine (K)-containing peptides was evaluated.
Test material
- Reference substance name:
- Castor oil, dehydrated
- EC Number:
- 264-705-7
- EC Name:
- Castor oil, dehydrated
- Cas Number:
- 64147-40-6
- Molecular formula:
- Not applicable for this UVCB.
- IUPAC Name:
- Castor oil, dehydrated
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Castor oil, dehydrated
- Physical state: Liquid, yellowish, clear
- Lot/batch No.: 12.002.030
- Storage condition of test material: ambient room temperature, dry storage, under light exclusion
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- other: not applicable
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not applicable as it is an in vitro study
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: Not applicable
- Vehicle:
- other: see below for information on vehicle
Challenge
- Route:
- other: Not applicable
- Vehicle:
- other: see below for information on vehicle
- No. of animals per dose:
- Not applicable
- Details on study design:
- Not applicable since this study is not a traditional test
- Challenge controls:
- Negative control (NC): vehicle control = propanol (PrOH). Acetonitrile (ACN) was performed as an additional vehicle control for the PC EGDMA.
Positive control (PC): Ethylene glycol dimethacrylate (EGDMA; CAS-no. 97-90-5) (prepared as a 50 mM solution in propanol and inacetonitrile). As EGDMA may result in different peptide depletions when formulated in different vehicles the standard vehicle was used in addition to the vehicle used for test substance formulation.
Co-elution control: Sample prepared of the respective peptide buffer and the test substance but without peptide. - Positive control substance(s):
- yes
- Remarks:
- Ethylene glycol dimethacrylate (EGDMA; CAS-no. 97-90-5) (prepared as a 50 mM solution in propanol and inacetonitrile).
Results and discussion
Any other information on results incl. tables
Reaction with cysteine-peptide
Reaction with cysteine peptide |
peak area [mAU*s] at 220 nm |
peptide concentration [mM] |
||||||
|
sample 1 |
sample 2 |
sample 3 |
sample 1 |
sample 2 |
sample 3 |
Mean |
SD |
NC: PrOH |
724.5 |
715.5 |
709.2 |
0.492 |
0.486 |
0.482 |
0.487 |
0.005 |
Castor oil, dehydrated - 12/0806-1 |
715.8 |
outlier* |
698.9 |
0.486 |
- |
0.475 |
0.481 |
0.008 |
PC: EGDMA in PrOH |
376.6 |
346.0 |
304.5 |
0.259 |
0.239 |
0.211 |
0.236 |
0.024 |
PC: EGDMA in ACN |
383.4 |
349.6 |
340.5 |
0.264 |
0.241 |
0.235 |
0.247 |
0.015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reaction with cysteine peptide |
Peptide depletion % |
||||
|
sample 1 |
sample 2 |
sample 3 |
Mean |
SD |
NC: PrOH |
-1.1 |
0.1 |
1.0 |
0.0 |
1.1 |
Castor oil, dehydrated - 12/0806-1 |
0.1 |
- |
2.4 |
1.2 |
1.6 |
PC: EGDMA in PrOH |
46.7 |
50.9 |
56.7 |
51.5 |
5.0 |
PC: EGDMA in ACN |
45.6 |
50.3 |
51.5 |
49.2 |
3.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Reaction with cysteine peptide |
peak area [mAU*s] at 258 nm |
Area ratio 220/258 |
||||
|
sample 1 |
sample 2 |
sample 3 |
sample 1 |
sample 2 |
sample 3 |
NC: PrOH |
18.7 |
20.3 |
20.3 |
38.7 |
35.2 |
35.0 |
Castor oil, dehydrated - 12/0806-1 |
20.1 |
- |
19.8 |
35.7 |
- |
35.3 |
PC: EGDMA in PrOH |
10.4 |
9.2 |
8.2 |
36.1 |
37.6 |
37.1 |
PC: EGDMA in ACN |
10.5 |
9.7 |
9.4 |
36.4 |
36.1 |
36.0 |
The peptide concentration and peptide depletion of the PC: EGDMA in ACN was calculated relative to the vehicle acetonitrile. The NC acetonitrile had a mean cysteine-peptide concentration of 0.485 mM (single data not shown).
*Sample 2 of the test substance was considered to be an outlier (peak area at 220 nm: 575.2) probably caused by an error during sample preparation and was hence not used for calculations.
Reaction with lysine-peptide
Reaction with lysine peptide |
peak area [mAU*s] at 220 nm |
peptide concentration [mM] |
||||||
|
sample 1 |
sample 2 |
sample 3 |
sample 1 |
sample 2 |
sample 3 |
Mean |
SD |
NC: PrOH |
662.6 |
662.7 |
661.2 |
0.495 |
0.495 |
0.494 |
0.495 |
0.001 |
Castor oil, dehydrated - 12/0806-1 |
673.3 |
679.7 |
674.8 |
0.503 |
0.508 |
0.504 |
0.505 |
0.002 |
PC: EGDMA in PrOH |
581.6 |
577.9 |
566.3 |
0.434 |
0.432 |
0.423 |
0.430 |
0.006 |
PC: EGDMA in ACN |
587.6 |
586.8 |
580.9 |
0.439 |
0.438 |
0.434 |
0.437 |
0.003 |
Reaction with lysine peptide |
Peptide depletion % |
||||
|
sample 1 |
sample 2 |
sample 3 |
Mean |
SD |
NC: PrOH |
-0.1 |
-0.1 |
0.1 |
0.0 |
0.1 |
Castor oil, dehydrated - 12/0806-1 |
-1.8 |
-2.7 |
-1.9 |
-2.1 |
0.5 |
PC: EGDMA in PrOH |
12.2 |
12.8 |
14.5 |
13.2 |
1.2 |
PC: EGDMA in ACN |
12.8 |
12.9 |
13.8 |
13.1 |
0.5 |
Reaction with lysine peptide |
peak area [mAU*s] at 258 nm |
Area ratio 220/258 |
||||
|
sample 1 |
sample 2 |
sample 3 |
sample 1 |
sample 2 |
sample 3 |
NC: PrOH |
19.0 |
18.9 |
18.4 |
34.9 |
35.1 |
36.0 |
Castor oil, dehydrated - 12/0806-1 |
19.4 |
19.5 |
18.7 |
34.7 |
34.9 |
36.0 |
PC: EGDMA in PrOH |
16.7 |
16.4 |
16.7 |
34.8 |
35.2 |
33.8 |
PC: EGDMA in ACN |
16.8 |
16.9 |
16.9 |
35.0 |
34.7 |
34.3 |
The peptide concentration and peptide depletion of the PC: EGDMA in Can was calculated relative to the vehicle acetonitrile. The NC acetonitrile had a mean lysine-peptide concentration of 0.503 mM (single data not shown).
Additional observations
The test substance was solved in propanol. However, when mixed with the peptide stock solutions the samples became opaque. Visual observation after the 24-hour incubation time did not reveal precipitates in all samples but the samples were emulsions, still. Thus the samples were centrifuged prior to HPLC analysis. No co-elution of test substance and peptide occurred as demonstrated by the area ratio 220/258 and the co-elution control.
Mean peptide depletion
|
Cysteine-peptide |
Lysine-peptide |
Mean of both depletions % |
||
|
Mean depletion % |
SD |
Mean depletion % |
SD |
|
Castor oil, dehydrated - 12/0806-1 |
1.2 |
1.6 |
-2.1 |
0.5 |
0.6 |
PC: EGDMA in PrOH |
51.5 |
5.0 |
13.2 |
1.2 |
32.3 |
PC: EGDMA in ACN |
49.2 |
3.1 |
13.1 |
0.5 |
31.2 |
Chemical reactivity was determined by mean peptide depletion and was rated as high,
moderate, low, or minimal3:
Mean peptide
depletion [%] Reactivity
> 42.47 high reactivity
> 22.62 < 42.47 moderate reactivity
> 6.38 < 22.62 low reactivity
< 6.38 minimal reactivity
3According to the classification tree model described by Gerberick et al. for substances with available molecular weight highly reactive test substance (mean peptide depletion > 42.47 %) is predicted to be a strong sensitizer, a moderately reactive test substance (22.62 % < mean peptide depletion < 42.47 %) a moderate sensitizer, a test substance of low reactivity (6.38 % < mean peptide depletion < 22.62 %) a weak sensitizer, and a test substance of minimal reactivity (mean peptide depletion < 6.38 %) a non-sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance shows a minimal chemical reactivity in the DPRA assay.
- Executive summary:
In the Direct Peptide Reactivity Assay (DPRA), the reactivity of the test substance towards synthetic cysteine (C)- or lysine (K)-containing peptides was evaluated (Kolle, 2013a). For this purpose, the substance was incubated with synthetic peptides for 24 h at room temperature and the remaining non-depleted peptide concentration was determined by high performance liquid chromatography (HPLC) with gradient elution and UV-detection at 220 nm. The test substance was solved in propanol and incubated in ratios of 1:5 for C-peptide or 1:24 for K-peptide based on absolute mass. Additionally triplicates of the concurrent vehicle control (= NC) were incubated with the peptides. Further, a co-elution control was performed in order to detect possible interference of the test substance with the peptides. The samples consisted of the test substance, vehicle and the respective peptide buffer but without peptide. Moreover the samples were additionally analysed by measuring UV absorbance at 258 nm and the area ratio 220 / 258 was calculated as a measure of peak purity. The peptide depletion of test-substance incubated samples was compared to the peptide depletion of the NC samples and expressed as relative peptide depletion. For the test substance, the mean peptide depletion as average of C- and K-peptide depletion was calculated and used for evaluation of the chemical reactivity. Based on the observed results and applying the prediction model proposed in Gerbericket al.(2007), it was concluded that castor oil, dehydrated showed minimal chemical reactivity in the DPRA under the chosen test conditions (Kolle, S, N, 2013).
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