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EC number: 222-294-1 | CAS number: 3407-42-9
- 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 Sensitization
Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
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:
- 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: Patch test
- Principles of method if other than guideline:
- Patch test were performed to determine the allergic potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Currently no LLNA Study is available for assessment
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Patch tested subjects were mostly patients with various facial dermatoses. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 1,2,10%
- Day(s)/duration:
- 48 or 72 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: white petrolatum
- Concentration / amount:
- 1,2,10%
- Day(s)/duration:
- 48 or 72 jhours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 327
- Details on study design:
- OTHER: Patch tested subjects were mostly patients with various facial dermatoses. Samples were prepared in 3 different concentrations using white petrolatum as a vehicle.Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself is not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration. Routine photo patch tests were also performed at the same time on most of the test subjects.
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1,2,10%
- No. with + reactions:
- 0
- Total no. in group:
- 327
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
- Executive summary:
The test chemical was patch tested on patients with various facial dermatoses at three different concentrations to determine suitable concentrations for patch testing.The test chemical samples were prepared in 3 different concentrations(1,2,10%) using white petrolatum as a vehicle. Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself was not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration.Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
Reference
Results of the Patch test
Concentration of test chemical in white petrolatum |
Reactions |
No of patients tested |
|
Allergic |
Irritant |
||
10 |
2.5 |
0.6 |
327 |
2* |
1.5 |
0 |
327 |
1 |
0.6 |
0 |
327 |
*- optimal concentration determined by the study
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been reviewed to determine the sensitizing potential of the test chemical in living organisms. These include in vivo experimental studies on humans along with estimated results for the test chemical.
The test chemical was patch tested on patients with various facial dermatoses at three different concentrations to determine suitable concentrations for patch testing. The test chemical samples were prepared in 3 different concentrations (1,2,10%) using white petrolatum as a vehicle. Forty-eight hours closed patch tests were performed using Al-tests or Torii-ban (a domestic product) in 1976, Al-tests, Torii-ban or Finn-chamber in 1977 (4, 10), and only Finn-chamber thereafter. No testing was conducted during the summer seasons. Reactions were read approximately one hour after the removal of the test material (at 48 hours after application) and on the next day (at 72 hours after application), following the ICDRG scoring standard. Any reactions stronger than + by ICDRG reading were counted. Reactions at 72 hours which were rated equal to or stronger than those at 48 hours were assumed to be allergic reactions, while the reverse were deemed irritant reactions. The optimal testing concentration may be the highest concentration never producing an irritant reaction, provided that the allergic reaction produced by that concentration in itself was not too severe to be very harmful to the patient or to his further reactivity (angry back syndrome). The optimal concentrations were thus determined by trying to approximate this ideal concentration. Irritant reactions were seen in only 1 case with 10% concentration of the test chemical. No other dermal reactions were observed in the patients tested with 2%, 1% test chemical. 2% test chemical was determined as the optimal concentration for the allergic reactions studies.Based on the above observations, the test chemical can be considered to be not sensitizing to skin.
This study is supported by the results of another study, where Chubu Patch Test Research Team has collaborated with 12 participating institutions to conduct a patch test for the test chemical. Among outpatients at the 12 participating institutions, the targeted patients where those who were suspected of cosmetic skin inflammation or post-inflammatory pigmentation. There were a total of 327 cases of 45 males and 282 females ranging in age from 12 to 78 years old. The patch test unit used Finn-chamber (Epitest, Finland) -Scanpor tape (Norgesplaster, Norway). The artificial light source for the light patch test was FL20SBLB or BL equipped with Dermaray I or type I (Eisai), and the irradiation energy was 3 J / cm2 (at 365 nm) or more. The test chemical was based on white petrolatum and has three levels of concentration i.e 10%, 2% and 1%. The patch test and the light patch test were performed according to the International Contact Dermatitis Research Team (ICDRG) standards, and the results of each arriving facility were registered in the following code: 0:- ; 1: Ph? + ; 2: Ph + ; 3: Ph廾or more, 4: + ?, 5: +, 6: Over and over, 7: IR? (Stimulation response + based on Japanese standard); 8: IR (Stimulated response廾over Japanese standard source), 9: NT (not tested). The computer used was FACOM 230-15 (Fujitsu) Hara. Of the 327 patients tested, significant stimulation response was observed only in 1 case with 10% test chemical. No reactions were observed in almost 300 patients when tested 10, 2, 1% test chemical in petrolatum. Based on these observations, the test chemical can be considered to be not sensitizing to skin.
The experimental results indicate a strong possibility that the test chemical was indeed not sensitizing to skin. Hence, it can be classified under the category “Not Classified” according to CLP Regulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The experimental results indicate a strong possibility that the test chemical was indeed not sensitizing to skin. Hence, it can be classified under the category “Not Classified” according to CLP Regulation.
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