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EC number: 245-010-8 | CAS number: 22457-23-4
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA not available at time of testing.
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- other: 10% Ethanol
- Concentration / amount:
- 100, 30, 10, 3% in 10% ethanol
- Route:
- epicutaneous, open
- Vehicle:
- other: 10% Ethanol
- Concentration / amount:
- 100, 30, 10, 3% in 10% ethanol
- No. of animals per dose:
- 6
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
- Executive summary:
Open Epicutaneous Test
Test Material is applied epicutaneously, uncovered, undiluted, and if possible and relevant, dissolved in concentrations of 30, 10, 3% in ethanol. Constant volumina of each concentration are applied with a pipette on standard areas of the clipped flank of each animal.
STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Abstract only
- Qualifier:
- according to guideline
- Guideline:
- other: The technique employed in this study was that of the repeated insult method approyed "by the Food and Drug Administration.
- Deviations:
- not specified
- Principles of method if other than guideline:
- The technique employed in this study was that of the repeated insult method approved by the "Food and Drug Administration".
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- LLNA not available at time of testing.
- Species:
- human
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The fifty-seven subjects were selected on a random basis in the order of their applying for participation in this study, except that no person was accepted who had active dermatologic conditions or other indicated illnesses. Previous sensitivities or a history of allergy were not considered to be reasons for rejection.
Out of the 57 volunteers who started this study, 53 completed all of the sensitivity tests and the challenge test series. The minimal loss of personnel in this full study resulted from personal reasons (two subjects developed upper respiratory infections during the study; one had a change in working hours and was unable to attend the tests; and one found it personally inconvenient).
Out of the 53 individuals who completed all of the tests, 50 were female and 3 male. Forty-seven of these subjects were between 18 and 32 years of age with the remaining six individuals being between 35 and 52 years of age.
The preponderance of female subjects increased the potentialities for sensitization and irritation responses. - Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Fifty-seven volunteers were inducted into this sensitization and challenge test study in accordance with the schedule and technique described in the Procedure. Fifty-three of these subjects completed the entire test series.
There were no reactions either irritative or allergenic to any of the preparations employed in this study. - Executive summary:
An investigation was conducted to ascertain the irritative and sensitizing potentialities of the titled seven coded preparations. Preparation DCIC was prepared in a 5% concentration, while the remaining six preparations were in 2% concentrations using dimethyl phthalate as the solvent.
Fifty-seven volunteers were inducted into this sensitization and challenge test study in accordance with the schedule and technique described in the Procedure. Fifty-three of these subjects completed the entire test series.
There were no reactions either irritative or allergenic to any of the preparations employed in this study.
Referenceopen allclose all
Single application test
Slovent: ethanol
Lowest irritant concentration = 100%
Highest non irritant concentration = 30%
Repeated applications over 21 successive days
Concentration % | Skin irritation after days | ||
7 | 14 | 21 | |
100 | (+) | (+) | + |
30 | - | (+) | (+) |
10 | - | - | - |
3 | - | - | - |
Degree of skin irritation:
–= none
+= slight
++= moderate
+++= strong
Capacity to induce allergic sensitization
After daily applications over three weeks Concentration in % |
Sensitisation rate Number of animals Positive/Total |
|
Day 21 | Day 35 | |
100 | 0/6 | 0/6 |
30 | 0/6 | 0/6 |
10 | 0/6 | 0/6 |
3 | 0/6 | 0/6 |
Results:
STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.
The study was conducted according to the schedule and procedures as discussed in the preceding section of this report. There were no complications and no alterations in the planned procedure were necessary.
Out of the 57 volunteers who started this study, 53 completed all of the sensitivity tests and the challenge test series. The minimal loss of personnel in this full study resulted from personal reasons (two subjects developed upper respiratory infections during the study; one had a change in working hours and was unable to attend the tests; and one found it personally inconvenient).
Out of the 53 individuals who completed all of the tests, 50 were female and 3 male. Forty-seven of these subjects were between 18 and 32 years of age with the remaining six individuals being between 35 and 52 years of age.
The preponderance of female subjects increased the potentialities for sensitization and irritation responses.
There were no reactions either irritative or allergenic at any time either during the sensitization series or as a result of the challenge tests.
Because of the large number of tests which were applied and the necessary adhesive materials to keep these tests in place, there were at different times twenty-two reactions of irritation to the adhesive tape. In four of these subjects the reactions were becoming discomforting toward the end of the sensitization series. In the remainder of the individuals who reacted to the tape, the responses were primarily redness and puffiness which had disappeared by the time it was necessary to repeat the tests in the same sites.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In several sensitisation studies, no sensitisation was observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the negative results of several studies, the material can be considered not sensitising for CLP.
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