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EC number: 241-409-6 | CAS number: 17372-87-1
- 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
Endpoint summary
Administrative data
Description of key information
No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
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 was performed to determine the allergic contact dermatitis caused by the chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in petrolatum
- Day(s)/duration:
- 2-3 days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50% in petrolatum
- Day(s)/duration:
- 2-3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 9 patients
- Details on study design:
- Details on study design
OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and
again at 4–7 days.
The reactions of the patients were graded as?+. + and ++ categories. - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- 9 patients were tested with the dye.No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
- Executive summary:
The sensitization potential of the test chemical was determined by performing patch tests on humans. 9 patients were tested with the test chemical.
50% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories
No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
Reference
Table 1: Patch test results
Chemical |
No of patients tested |
?+ |
+ |
++ |
17372 -87 -1 (50% petrolatum.) |
9 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been reviewed to determine the allergenic potential of the test chemical in living organisms. These include experimental results performed on humans for the test chemical. The studies are summarized as follows:
The sensitization potential of the test chemical was determined by performing patch tests on humans. 9 patients were tested with the test chemical.
50% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories
No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.
In similar manner patch test was conducted on 81 year old male patient with a history of recurrent leg dermatitis to determine the contact sensitization caused by the test chemical.
The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 50% in petrolatum. Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.
After 2 months he was again patch tested with test chemical at dose of 1% in petrolatum which produced strong allergic reaction (++).
Strong allergic reaction (++) was obtained when the patient was tested with 1% in petrolatum. Therefore the test chemical was considered as skin sensitizing to the skin.
This is supported by the results of a study in which a patch test was conducted on a 24 year old tennis player who had a 5 month history of an unhealed itching injury on his left leg to assess sensitization potential of test chemical.
The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 1% and 50% in petrolatum. Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.
The patient developed strong positive reaction (++) at both the tested concentration. Hence the test chemical was considered as sensitizing to the skin.
These results are further supported by a study where a patch test was conducted on a 64 year old female patient with a past history of recurrent contact dermatitis with an extensive leg ulcer due to the test chemical.
The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 2% (aqueous) and 50% (Petrolatum). Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.
Strong allergic reaction was observed in treated patients at dose of 2% aq. (++) and 50% petro (+++).
Hence the test chemical was considered as sensitizing to the skin.
The above results are supported by a study where patch test was conducted on 64 year old female patient suffering from ulcus cruis developed erythema and vesicles on her right leg and right forearm due to exposure to the test chemical. The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 2% (aqueous) and 1% and 50% (petrolatum). Patches were removed and a second reading was made after 2 days. Reactions were recorded according to the ICDRG scoring system.
Since the chemical produced allergic skin reaction at the tested concentration, the test chemical was considered as sensitizing to the skin.
Eventhough the key study claims that the test chemical does not cause any dermal reactions in 9 patients, but strong allergic reactions were observed in the remaining studies. Taking in to consideration the results of the majority supporting studies, the test chemical can be considered to cause an allergic reaction to skin. Hence, it can be considered to be a potential skin sensitizer. Comparing the annotations with the criteria of CLP, the test chemical can be classified under the category “Skin Sensitizer 1”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Eventhough the key study claims that the test chemical does not cause any dermal reactions in 9 patients, but strong allergic reactions were observed in the remaining studies. Taking in to consideration the results of the majority supporting studies, the test chemical can be considered to cause an allergic reaction to skin. Hence, it can be considered to be a potential skin sensitizer. Comparing the annotations with the criteria of CLP, the test chemical can be classified under the category “Skin Sensitizer 1”.
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