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EC number: 247-368-0 | CAS number: 25956-17-6
- 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
Endpoint summary
Administrative data
Description of key information
Skin Irritation
The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients. The test chemical falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that the test chemical was not irritating to rabbit ears.
Eye Irritation
An ocular irritation study was carried out to assess the irritation potential of the test chemical.0.1 ml of 1.0% aqueous solution of the test chemical was instilled into the rabbit eyes and the effects were observed (duration not specified).0.1 ml of 1.0% aqueous solution of the test chemical did not any changes in rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.
An in vitro assay was performed using Hen’s egg test on the chorioallantoic membrane (HET-CAM) with a 1 % aqueous dilution of the test chemical to determine its irritation potential. The 1% aqueous solution of the test chemical did not cause any damaging effect on the CAM as the obtained evaluation resulted in score 0 Hence, the test chemical can be considered to be not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the comedogenicity and irritancy potential of the test chemical in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: No data
Age at study initiation: No data
Weight at study initiation: 3 kg
Fasting period before study: No data
Housing: singly housed, in suspended cages
Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
Water (e.g. ad libitum): water, ad libitum
Acclimation period: No data
ENVIRONMENTAL CONDITIONS
Temperature (°C): No data
Humidity (%):No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): 12 hour light and 12 hr dark cycle
IN-LIFE DATES: From: No data To: No data - Type of coverage:
- other: Entire inner surface of one ear
- Preparation of test site:
- other: A colony of rabbits that had genetically good ears and which were free from mites were used for the assay
- Vehicle:
- other: The test chemical was mixed in propylene glycol at a 9 to 1 dilution for testing.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Dose of 1ml of the test material was applied once daily for five days per week for 2 weeks.
- Duration of treatment / exposure:
- five days per week for 2 weeks
- Observation period:
- 2 weeks
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
Area of exposure: Ear
% coverage: A dose of 1ml of the test chemical is applied and spread once daily to the entire inner surface of one ear five days per week for 2 weeks.
Type of wrap if used: No data
REMOVAL OF TEST SUBSTANCE
Washing (if done): No data
Time after start of exposure: No data
SCORING SYSTEM: The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:
0 = No irritation
1 = few scales, no Erythema
2 = diffuse scaling, no Erythema
3 = Generalized scaling with Erythema
4 = Scaling, Erythema and Edema
5 = Epidermal necrosis and slough - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 2
- Max. score:
- 5
- Reversibility:
- no data
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Grade 2 indicates diffuse scaling, no Erythema
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test chemical falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that the test chemical was not irritating to rabbit ears.
- Executive summary:
The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients. Ingredients are mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated ( 10% concentration). A colony of New Zealand albino rabbits that have genetically good ears and is free from mites is used. Three rabbits, weighing two to three kilograms, are used for each assay. Animals are housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals are maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of test chemical was applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control. The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:
0 = No irritation, 1 = few scales, no Erythema, 2 = diffuse scaling, no Erythema, 3 = Generalized scaling with Erythema, 4 = Scaling, Erythema and Edema
and 5 = Epidermal necrosis and slough.
The test chemical falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that the test chemical was not irritating to rabbit ears.
Reference
Table 1: Ingredients and their Comedogenicity and Irritancy
Test chemical |
Comedogenicity* [Grade 0-5] |
Irritancy** [Grade 0-5] |
2 |
2 |
*Comedogenicity or the ability of test substance to produce follicular hyperkeratosis
** Irritancy or ability of test substance to produce surface epithelial irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate the ocular irritation potential of the test chemical
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml of 1.0% aqueous solution
- Duration of treatment / exposure:
- no data available
- Observation period (in vivo):
- no data available
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- no data available
- Details on study design:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: not specified
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No changes were observed, hence the test chemical can be considered as not irritating
- Interpretation of results:
- other: not irritating
- Conclusions:
- 0.1 ml of 1.0% aqueous solution of the test chemical had no cause any changes in rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.
- Executive summary:
An ocular irritation study was carried out to assess the irritation potential of the test chemical.0.1 ml of 1.0% aqueous solution of the test chemical was instilled into the rabbit eyes and the effects were observed (duration not specified).0.1 ml of 1.0% aqueous solution of the test chemical did not cause any changes in rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: chorioallantoic membrane (HET-CAM)
- Principles of method if other than guideline:
- Assessment of the eye irritation potential of the test chemical in the Hen’s egg test on the chorioallantoic membrane (HET-CAM)
- GLP compliance:
- not specified
- Species:
- other: Hens egg
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 1 % aqueous dilution
- Duration of treatment / exposure:
- at day 9 of incubation for 30 sec
- Number of animals or in vitro replicates:
- 6 eggs per groups
- Details on study design:
- TEST SITE
- Area of exposure: chorioallantoic membrane
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds
- Time after start of exposure: no data
SCORING SYSTEM: - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other: not irritating
- Conclusions:
- The 1% aqueous solution of test chemical did not cause any damaging effect on the CAM as the obtained evaluation resulted in score 0 . Hence, the test chemical can be considered to be not irritating to eyes.
- Executive summary:
Hen’s egg test on the chorioallantoic membrane (HET-CAM) were performed with a 1 % aqueous dilution of the test chemical.The diluted test item was applied onto the CAM of fertilized chicken eggs at day 9 of incubation and was rinsed off 30 sec after application and evaluation of the irritation parameters was performed. The 1% aqueous solution of the test chemical did not cause any damaging effect on the CAM as the obtained evaluation resulted in score 0
Hence, the test chemical can be considered to be not irritating to eyes.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation
Various studies have been summarized to evaluate the dermal irritation potential of the test chemical in living organisms. These include in vivo experimental studies performed on rabbits for the test chemical.
The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients. Ingredients are mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated ( 10% concentration). A colony of New Zealand albino rabbits that have genetically good ears and was free from mites was used. Three rabbits, weighing two to three kilograms, are used for each assay. Animals are housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals are maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of test chemical was applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control. The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear was evaluated on a scale of 0 to 5. The grades are summarized as follows:
0 = No irritation, 1 = few scales, no Erythema, 2 = diffuse scaling, no Erythema, 3 = Generalized scaling with Erythema, 4 = Scaling, Erythema and Edema and 5 = Epidermal necrosis and slough. The test chemical falls under Grade 2 (diffuse scaling and no erythema). Hence it can be concluded that the test chemical was not irritating to rabbit ears.
This is supported by the results of the tests for dermal irritations on intact and abraded skin were performed on rabbits. 0.316, 1.0, 3.16 and 10 g/kg bw of the test chemical was applied on the skin of rabbits and observed for effects. The test chemical showed no gross irritation at levels tested; also no skin staining occured. Hence, the test chemical was considered to be not irritating to skin.
The above results are further supported by a Prophetic patch test used for determination of cutaneous toxicity of a chemical compound.
The test chemical was applied either as a neat or as a 25% aqueous solution to the skin of 200 human subjects. The initial exposure to the compound was for 72 hours, and this was followed by a 24-hour application 10 to 14 days later. None of the subjects exhibited compound induced irritation. Hence, the test chemical was considered to be not irritating to skin.
These results are also supported by a study performed to determine the dermal irritation potential of the test chemical in rabbits.
The test chemical was applied daily at rates of 0.5 g/kg, five days a week for 15 applications on abraded and 65 applications on intact skin of rabbits, of 0.1 and 1% solutions in water or as a hydrophilic ointment and observed for effects.No dermal irritation was noted after daily application of the test chemical. Also, No changes in the body weight, clinical laboratory studies and gross and microscopic pathology were observed. Hence, the test chemical was considered to be not irritating to skin.
Based on the available results, the test chemical can be considered to lack the potential to cause irritation/corrosion to skin. Hence, the test chemical can be considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulations, the test chemical can be classified under the category “Not Classified”.
Eye irritation
In different studies, the test chemical has been investigated for potential for ocular irritation in living organisms to a greater or lesser extent. These include in vivo experimental studies performed on rabbits as well as in vitro experimental studies for the test chemical. The results are summarized as follows:
An ocular irritation study was carried out to assess the irritation potential of the test chemical.0.1 ml of 1.0% aqueous solution of the test chemical was instilled into the rabbit eyes and the effects were observed (duration not specified).0.1 ml of 1.0% aqueous solution of the test chemical did not any changes in rabbit eyes. Hence, the test chemical can be considered not irritating to rabbit eyes.
This is supported by an in vitro assay performed using Hen’s egg test on the chorioallantoic membrane (HET-CAM) with a 1 % aqueous dilution of the test chemical to determine its irritation potential. The diluted test item was applied onto the CAM of fertilized chicken eggs at day 9 of incubation and was rinsed off 30 sec after application and evaluation of the irritation parameters was performed. The 1% aqueous solution of the test chemical did not cause any damaging effect on the CAM as the obtained evaluation resulted in score 0
Hence, the test chemical can be considered to be not irritating to eyes.
The above in vitro result is supported by another in vitro screening assay using the measurement of cytotoxicity in human keratinocytes (NRU-assay) was performed to assess the ocular irritation potential of the test chemical. Monolayers of human keratinocytes (HaCat) were exposed in 96-well microtiter plates to various concentrations of the test chemical for 24 hours and cell viability was measured by neutral red uptake. The concentration causing a 50 % reduction in neutral red uptake compared to the concurrent control (NRU-50) is determined. This figure, as a measure for cytotoxicity of a test item in this cell culture, is compared to findings with known eye irritants under identical test conditions and allows a prediction of the eye irritation potential of a test item. No NRU-50 value could be determined as the viability was still 71 % in the first and 69 % in the second assay after treatment with the highest test concentration of 10000 μg/ml medium. Thus, the NRU-50 was > 10000 μg/ml. The NRU-50 values obtained with the positive control SLS (12.5 and 15.6 μg/ml) were in the range of the historical control data of the laboratory and demonstrate the validity and sensitivity of the assay.
According to the classification system of the performing laboratory discriminating between nonirritant, not-classified and severe, the test chemical was classified as non-irritant, as the cut-off for this classification is ≥750 μg/ml under the described test conditions.
The in vitro and the in vivo results are in agreement with each other, indicating a very strong possibility that the test chemical lacks the potential to cause any irritation to eyes. Hence, the test chemical can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulations, the test chemical can be classified under the category “Not Classified”.
Justification for classification or non-classification
Based on the available results, the test chemical can be considered to lack the potential to cause irritation/corrosion to skin. Hence, the test chemical can be considered to be not irritating to skin. Comparing the above annotations with the criteria of CLP regulations, the test chemical can be classified under the category “Not Classified”.The in vitro and the in vivo results are in agreement with each other, indicating a very strong possibility that the test chemical lacks the potential to cause any irritation to eyes. Hence, the test chemical can be considered to be not irritating to eyes. Comparing the above annotations with the criteria of CLP regulations, the test chemical can be classified under the category “Not Classified”.
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