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EC number: 203-775-5 | CAS number: 110-52-1
- 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
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Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of test chemical was assessed in various experimental studies conducted on mose lymphoma. Based on the available data for the target and supporting studies, it can be concluded that the test chemical is not able to cause skin sensitization and thus cannot be considered as sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not sensitizing”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data from various test chemicals
- Justification for type of information:
- Data is summarized based on the available information from various read across test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 skin sensitization studies as - WoE 2 and WoE 3
Skin sensitization test was carried out to study the effects of the test chemical on rodents. - GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- No data available
- Species:
- mouse
- Strain:
- other: 2.Not specified 3.CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- 2.Not specified
3.TEST ANIMALS
Source: No data
Age at study initiation: 7-12 weeks - Vehicle:
- other: AOO (Acetone/olive oil, 80/20 v/v)
- Concentration:
- 2. 5%, 10% and 25%
3.25 µL - No. of animals per dose:
- 2.Not specified
3.groups of female mice (number not specified) - Details on study design:
- 2.Not specified
3.Pre –screen tests : No data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). Dose response data were used to measure the relative skin sensitization potency of all of the chemicals that were positive. When the LLNA dose-response curve included concentrations that induced at least one SI greater than 3 and one SI less than 3, EC3 values were calculated by linear interpolation. For chemicals that induced an SI greater than or equal to 3 at all concentrations tested, an EC3 value was extrapolated from the two lowest doses used. For this extrapolation method to work, a dose response should be evident. The relative sensitizing potencies of the chemical allergens were categorized via a recently proposed arbitrary classification scheme.
TREATMENT PREPARATION AND ADMINISTRATION: groups of CBA female mice (7–12 weeks of age) were exposed topically on the dorsum of both ears to 25 µL of test material or to an equal volume of the relevant vehicle alone. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were sacrificed 5 hours later, and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute (dpm). A stimulation index (SI) was calculated for each chemical-treated group as the ratio of the dpm of the treated group (or mean dpm when individual animals were assessed) to the dpm or mean dpm of the concurrent vehicle control group. - Positive control substance(s):
- not specified
- Statistics:
- 2.Not specified
3. - Positive control results:
- 2.Not specified
3. - Parameter:
- other: T/C ratio
- Remarks:
- 2
- Value:
- 1.2
- Test group / Remarks:
- Concentartion 5%
- Remarks on result:
- other: Not sensitizing
- Parameter:
- other: T/C ratio
- Remarks:
- 2
- Value:
- 1.4
- Test group / Remarks:
- Concentration 10%
- Remarks on result:
- other: Not sensitizing
- Parameter:
- other: T/C ratio
- Remarks:
- 2
- Value:
- 2.1
- Test group / Remarks:
- Concentration 25%
- Remarks on result:
- other: Not sensitizing
- Parameter:
- SI
- Remarks:
- 3
- Value:
- 2.8
- Remarks on result:
- other: Not sensitizing
- Cellular proliferation data / Observations:
- 2.Not specified
3. - Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Based on all the observations and results, it was concluded that the test chemical is not sensitizing to skin.
- Executive summary:
Various studies has been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in mice for test chemical are summarized as below;
The dermal sensitization potential of the given test chemical was evaluated in a mouse local lymphnode assay (LLNA). Groups mice were exposed topically on the dorsum of both ears to 5%, 10% and 25% of the test material or to an equal volume of relevant vehicle only. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected intravenously with [H3] thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes. The approach to estimation of the relative skin sensitization potential was based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value. A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.1 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.
In another study, the dermal sensitization potential of the given test chemical was evaluated in a mouse local lymphnode assay (LLNA). The study was performed as per OECD 429 Guidelines. Groups of female CBA mice (7-12 weeks of age) were exposed topically on the dorsum of both ears to 25µl of the test material or to an equal volume of relevant vehicle only. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were sacrificed 5 hours later, and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute (dpm). A stimulation index (SI) was calculated for each chemical-treated group as the ratio of the dpm of the treated group (or mean dpm when individual animals were assessed) to the dpm or mean dpm of the concurrent vehicle control group. The approach to estimation of the relative skin sensitization potential was based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value.A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.8 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.
All these studies lead to a conclusion that Test chemical is indeed not sensitizing to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Sensitizing”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies has been investigated for the test chemical to observe the potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in mice for test chemical are summarized as below;
The dermal sensitization potential of the given test chemical was evaluated in a mouse local lymphnode assay (LLNA). Groups mice were exposed topically on the dorsum of both ears to 5%, 10% and 25% of the test material or to an equal volume of relevant vehicle only. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected intravenously with [H3] thymidine and activity measured as a function of isotope incorporation in draining auricular lymph nodes. The approach to estimation of the relative skin sensitization potential was based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value. A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.1 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.
In another study, the dermal sensitization potential of the given test chemical was evaluated in a mouse local lymphnode assay (LLNA). The study was performed as per OECD 429 Guidelines. Groups of female CBA mice (7-12 weeks of age) were exposed topically on the dorsum of both ears to 25µl of the test material or to an equal volume of relevant vehicle only. Treatment was performed daily for 3 consecutive days. Five days after the initiation of exposure, all mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine. Mice were sacrificed 5 hours later, and the draining auricular lymph nodes were excised and pooled for each experimental group or each individual animal. The incorporation of tritiated thymidine measured by beta scintillation counting was reported in disintegrations per minute (dpm). A stimulation index (SI) was calculated for each chemical-treated group as the ratio of the dpm of the treated group (or mean dpm when individual animals were assessed) to the dpm or mean dpm of the concurrent vehicle control group. The approach to estimation of the relative skin sensitization potential was based on the mathematical estimation of the concentration of chemical necessary to obtain a threshold positive response (SI = 3); this is termed as the EC3 value.A substance was classified as a skin sensitizer if it induced a threefold or greater increase in local lymph node proliferative activity at one or more test concentrations when compared with concurrent vehicle-treated controls (SI≥3). The values for Stimulation Indices at various test concentrations were 1.2, 1.4 and 2.8 which are below 3, hence EC3 value couldnot be calculated. Therefore, the given test chemical was considered to be not sensitizing to skin of mice.
All these studies lead to a conclusion that Test chemical is indeed not sensitizing to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Sensitizing”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test substance were observed in various studies. From the results obtained from these studies it is concluded that the test chemical is not likely to cause skin sensitization and hence can be classified as “Not sensitizing”.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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