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EC number: 943-460-6 | CAS number: 1360828-80-3
- 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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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May to 28 July, 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- An in vivo test was done for chemical registration purposes in China in accordance with the Guidelines for the testing of chemicals "Skin Sensitization Study" (406) published by the Ministry of Environmental Protection of People's Republic of China in 2013. The test results are being provided for classification purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- China in accordance with the Guidelines for the testing of chemicals "Skin Sensitization Study" (406) published by the Ministry of Environmental Protection of People's Republic of China in 2013.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An in vivo test was done for chemical registration purposes in China in accordance with the Guidelines for the testing of chemicals "Skin Sensitization Study" (406) published by the Ministry of Environmental Protection of People's Republic of China in 2013. The test results are being provided for classification purposes.
Test material
- Reference substance name:
- (1R,2R)-1-amino-2-difluoromethyl)-N- (1-methylcyclopropylsulfonyl)cyclo propanecarboxyamide hydrochloride
- EC Number:
- 943-460-6
- Cas Number:
- 1360828-80-3
- Molecular formula:
- C9H15CIF2N203S
- IUPAC Name:
- (1R,2R)-1-amino-2-difluoromethyl)-N- (1-methylcyclopropylsulfonyl)cyclo propanecarboxyamide hydrochloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- White solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- Albino
- Sex:
- female
- Details on test animals and environmental conditions:
- On arrival, the guinea pigs were between 4 to 6 weeks old and in the weight range of 254 to 313 g. Prior to test administration, the guinea pigs were between 5 to 7 weeks old and in the weigh trange of 300.03 to 357.27 g. The guinea pigs were female, nulliparous, and non-pregnant. All animals were acclimatized for 8 days prior to the study.
The animals were fed pellet diet with complete nutrition and were provided with purified water. Food and water were available to the animals ad libitum during the test. They were housed in plastic cages with corn cob bedding and each cage contained no more than 12 animals. The temperature in the animal roooms were between 17 to 23°C and the relative humidity was between 40 to 70%. The animals experienced 12 hours of light and 12 hours of dark.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.4 mL
- Day(s)/duration:
- Days 0, 7, and 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.3 mL
- Day(s)/duration:
- Day 27
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 32 animals total were divided into three groups. One preliminary irritation test group (2 animals), one negative control group (10 animals), and one treated group (20 animals).
- Details on study design:
- For the treated animal group, the left flanks of the guinea pigs were clipped free of hair. For both treated and control groups animals in the challenging group, right flanks of the guinea pigs were clipped free of hair on the morning prior to testing. The induction treatment group was given 0.255 g of raw test material via a patch. The treated group was given dosing on the left flank on day 0 (first induction day), day 7 and day 14. The negative control group received no treatment. The patches were rmoved after 6 hours of exposure and the test sites were gently cleanse dof any residual test item with water. At approximately 24 hours after the patch was removed, each dosing site was observed for both erythema and edema. The challenging treatment and control groups were given 0.237 g of raw test material via a patch. The challenge treatment and control groups were dosed on their right flanks on day 27. At appxoimately 24 and 48 hours after exposure, the application sites were observed for erythema and edema.
All animals were observed once per day for mortality and moribund states during the test period. Animals were weighed on arrival day, grouping day, and at the end of the study.
At the end of the test all surviving animals were euthanized by carbon dioxide asphyxiation and discarded without necropsy. - Challenge controls:
- Challenge controls were dosed with 0.237 g of raw test materialls via a patch.
- Positive control substance(s):
- yes
- Remarks:
- DNCB (2,4-Dinitrochlorobenzene)
Results and discussion
- Positive control results:
- Historical data for the skin sensitization results of positive control 2,4-Dinitrochlorobenzene (DNCB) were referred to. DNCB resulted in a severity index of 0.85, 24 hours following removal of the patch in the treated group. DNCB resulted in a severity indext of 1.45, 48 hours following removal of the patch in the treated group. The incidence for the treated group was 16/20.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Induction 1: Day 0: 24 hours after removal of test patches
- Group:
- test chemical
- Dose level:
- 0.255 g raw test material and 0.4 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible changes were observed in all animals of treated group.
- Reading:
- other: Induction 2: Day 7: 24 hours after removal of test patches
- Group:
- test chemical
- Dose level:
- 0.255 g raw test material and 0.4 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible changes were observed in all animals of treated group
- Reading:
- other: Induction: 3: Day 14: 24 hours after removal of test patches
- Group:
- test chemical
- Dose level:
- 0.255 g raw test material and 0.4 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible changes were observed in all animals of treated group
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.237 g raw test material and 0.3 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible changes were observed in all animals of both negative control group and treated group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.237 g raw test material and 0.3 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No visible changes were observed in all animals of both negative control group and treated group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.237 g raw test material and 0.3 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible changes were observed in all animals of both negative control group and treated group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.237 g raw test material and 0.3 mL purified water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible changes were observed in all animals of both negative control group and treated group
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- positive control
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on above results, Difluorosulfonamide HCl is not a skin sensitizer to guinea pigs.
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.
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