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EC number: 205-785-5 | CAS number: 151-13-3
- 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
Endpoint summary
Administrative data
Description of key information
The substance and its analogues are not irritating to skin and eye
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Remarks:
- Acute dermal toxicity protocol
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 402, Acute Dermal Toxicity
- Principles of method if other than guideline:
- Relevant data are obtained on the endpoint in studies of acute dermal toxicity and skin sensitisation
- GLP compliance:
- not specified
- Remarks:
- not specified in publication
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 5000 mg/kg bw. Considering a density of 0.9326 and average weight of a test rabbit of 2 kg, a dose of approximately equivalent to 2.7 ml was applied to the torso of the animals
- Duration of treatment / exposure:
- Not specified
- Observation period:
- Not specified
- Number of animals:
- 6
- Details on study design:
- not specified
- Irritation parameter:
- other: qualitative assessment
- Remarks:
- visual examination
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no skin irritation effects noted among the other pathologies described in report
- Irritant / corrosive response data:
- In an acute dermal toxicity study with 6 rabbits with occlusive exposure for 24 h, 1 animal died and necropsy results were described. No mention was made of skin irritation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute dermal toxicity study in rabbits was informative for the endpoint of skin irritation. Animals exposed to the analogue test substance under an aggressive protocol failed to show notable skin irritation. This data suggests that, like other structural analogues, the target (registered) test substance is not a skin irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Vertellus, Lot# 0000143574
- Expiration date of the lot/batch: 2018 March 21
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, closed container, in a dry, well ventilated location
- Stability under test conditions: assumed to be stable - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Local slaughterhouse, e.g. A. Moksel AG, Buchloe, Germany.
ENVIRONMENTAL CONDITIONS : room temperature, closed container, in a dry, well ventilated location
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS. Before mounting the corneas in corneal holders (BASF, Duratec) with the endothelial side against the O-ring of the posterior chamber, they were visually examined for defects and any defective cornea were discarded. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red) containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always be filled first. The corneas were incubated for one hour at 32 ± 1 °C. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- 10 min
- Duration of post- treatment incubation (in vitro):
- 2 hr
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: The assay used isolated corneas obtained as a by-product from animals freshly slaughtered at an abattoir, e.g. A. Moksel AG, Buchloe, Germany.
QUALITY CHECK OF THE ISOLATED CORNEAS : The eyes were carefully examined for defects and any defective eyes will be discarded.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : Physiological saline 0.9% NaCl
SOLVENT CONTROL USED (if applicable) : N/A
POSITIVE CONTROL USED : 100% Ethanol
APPLICATION DOSE AND EXPOSURE TIME : 750 µL, 10 min
TREATMENT METHOD: Closed chamber
POST-INCUBATION PERIOD: Yes, 2 hr
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 3
- POST-EXPOSURE INCUBATION: Yes, 2 hr
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: BASF-OP3.0, Duratec
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490) , Jenway 6405
- Others (e.g, pertinent visual observations, histopathology): Each cornea was observed visually and pertinent observations were recorded.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Opacity is determined using a manufacturer-specific formula, using illuminance through a holder without cornea and illuminance through a holder with cornea as independent variables. Change in opacity between treated and untreated samples is determined, and the irritation potential of the test substance is evaluated based upon the following conditions:
≤ 3: No Category
> 3; ≤ 55: No prediction can be made
> 55: Category 1 - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 1.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0.91
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: permeability score
- Run / experiment:
- mean
- Value:
- 0.013
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: N/A - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was evaluated for potential to cause eye irritation using an ex vivo BCOP assay according to OECD guideline 437. An in vitro irritation score of 1.10 was calculated based on corneal opacity and permeability following treatment of the ex vivo eye model with the test substance. The test substance did not meet GHS criteria for classification of eye irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Experimental data are lacking on a guideline skin irritation test of butyl ricinolate. As an ester of ricinoleic acid, the primary fatty acid of castor oil, the substance is not considered a skin irritant in experimental or clinical settings. Dermaleffects (sensitisation and irritation) were not observed for an analogue, methyl ricinoleate (Manciaux, 1999) or ethyl ricinoleate (clinical studies, Johnson, 2007). No local irritation was demonstrated for the methyl ester of 12-hydroxystearic acid in skin and eye irritation testing (Gross, 2018). The Cosmetic Ingredient Review Expert Panel (CIR) concluded that castor oil derived esters are not irritating (Johnson, 2007).
Using the structure of the IATA for skin irritation (ECHA, 2016), the follow analysis is obtained:
1. There are no physico-chemical properties of butyl ricinoleate which are associated with skin irritation.
2. There are existing human clinical data on a structural analogue, ethyl ricinoleate, which shows no skin irritation under 48-hour occlusive patches (Johnson, 2007). The overall assessment on a category of structurally related ricinoleate compounds is that the category members overall are not skin irritants for exposures from intentionally applied consumer products (Johnson, 2007). There are clinical case reports of the acid itself resulting in skin irritation; these are evaluated by the Expert Panel of toxicologists and clinicians of the CIR; these data have not changed the panel’s conclusion that the category members are non-irritants. Sato et al., 1996, showed that the esters of C8-C18 carboxylic acids are essentially nonirritating in comparison with the activity of a series of carboxylic acids, alcohols and aldehydes. The findings of patch testing as well as nitrocellulose-replica analysis of the local skin anatomy revealed that C8-C12 carboxylic acids were the most irritating of the series, whereas C16-C18 showed no irritation. The acids were relatively more irritating than alcohols and aldehydes, but esters of all chain lengths were nonirritating.
3. In experimental studies in rabbits, ethyl ricinoleate showed no skin irritation in an acute dermal toxicity study (Johnson, 2007). Methyl ricinoleate showed no skin irritation in an epicutaneous sensitisation study (Manciaux, 1999). Another structural analogue, the methyl ester of 12-hydroxystearic acid, showed no dermal irritation in an OECD 492in vitroreconstructed skin model (Gross, 2018). These data are supportive of the position of the CIR that ricinoleate esters are not skin irritants. In experimental research experience, Patzelt et al., 2011, documented the failure of oils (fatty acid glyceryl esters) to penetrate into the stratum corneum. Mack-Correa and colleagues, 2013, using trans-epidermal water loss (TEWL) and various microscopic techniques, documented the lack of percutaneous absorption of glyceryl trioleate whereas the corresponding acid, oleic acid, was measured quantitatively in the dermis, and was associated with interruption of the normal lipid structure of the skin.
4. Structure-activity relationship modeling was not undertaken, as there are few models which have been validated for prediction of this outcome.
5. As there is no indication of skin irritation as a result of dermal exposure, the possibility of skin corrosion from exposure is not entertained.
The result of this integrated evaluation of the existing data on butyl ricinoleate analogues and category members is that the esters of ricinoleate have adequate data indicating that butyl ricinoleate is not a skin irritant.
References:
ECHA, 2016. Information Requirement and the Chemical Safety Report, Endpoint specific Guidance, Chapter R.7a, v.5.0, December.
Gross, C. 2018. Test Report, Eurofins Biopharma, Munich, Germany, 22 March. 2018.
Johnson, W., Jr. 2007. Int. J. Toxicol. 26 (Suppl 3):31-77.
Mack-Correa, M.C., Mao, G., Saad, P., et al., 2014. Exper. Dermatol. 23: 39-44
Patzelt, A., Lademann, J., Richter, H., et al., 2012. Skin Research Technol. 18: 364-369.
Sato A., Obata, K., Ikeda, Y. 1996. Contact Dermatitis, 34:12-16.
Justification for classification or non-classification
The substance does not meet the criteria for classification as a skin or eye irritant, according to Regulation EC No. 1272/2008.
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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