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Diss Factsheets
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EC number: - | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 13, 2018 to April 25, 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 21604-2008 Chemicals-Test method of acute dermal irritation/corrosion
- GLP compliance:
- no
- Remarks:
- According GLP but not certified
Test material
- Reference substance name:
- Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
- Cas Number:
- 2210238-42-7
- IUPAC Name:
- Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
- Test material form:
- solid
- Remarks:
- This solid sample was obtained from the original liquid form by removing water.
- Details on test material:
- CAS number: 2210238-42-7
Constituent 1
- Specific details on test material used for the study:
- -Storage conditions
Store container tightly closed in well-ventilated place. Store in corrosive resistant container with a resistant inliner. Store locked up. Don't store with acids.
-Test item stability under storage conditions
Stable in container after opening. Stable in water and in light. Stability in soil is not applicable.
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
4 male healthy and adult rabbits with 2.3 - 2.5 kg body weight which purchased from TianQin biotechnology Ltd., Changsha. The number of the manufacturing license: SCXK(Xiang) 2014-0010. On arrival, the animals were acclimated to the laboratory accommodation 5 days before commencement of the exposure.
Common nutrient feed were supplied by TianQin Biotechnology Ltd., Changsha. The number of the manufacturing license: SCXK(Xiang)2014-0011.
The animals were housed in common environment. The temperature of the experimental animal room was 21 - 23°C and the relative humidity was 44 - 60 percent. The used license NO. of the experimental animal: SYXK(Xiang) 2017-0001.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- About 0.5 g test substance, wetted with pure water, was applied uniformly to a small area of skins on the left sides of the animals. The area for applying the test substance should be smaller than which was prepared.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours to the 12th day after patch removal.
- Number of animals:
- 4
- Details on study design:
Approximately 24 h before the test, about 3 cm x 3 cm areas of fur was removed from both left and right sides of the animals dorsal. Only the animals with healthy intact skins were used.
About 0.5 g test substance, wetted with pure water, was applied uniformly to a small area of skins on the left sides of the animals. The area for applying the test substance should be smaller than which was prepared. The test substance was covered with a gauze patch, which was fixed with nonirritating tapes throughout the 4 h exposure period. At the end of the exposure period, the residual test substance was removed with water.
The signs of skin irritation at application site were observed at 24, 48, 72 h to the 12th day after patch removal. The scores were recorded. Adjacent areas of untreated skins of each rabbit served as control for the test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Mild erythema and edema for 3 animals were observed at 24 h after the residual test substance removed, purple-red erythema and eschar were observed in one of these three animals at 48 h, and recovered at the 12th day, the skin irritations of other 2 animals alleviated and recovered during 72 h to the 4th day. No skin irritation was observed in the other animal during the observation period.
The result and contents were showed in table 2.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result, registration substance do not met the GHS criteria.
- Executive summary:
The body weights of animals increased at the end of the test.
Mild erythema and edema for 3 animals were observed at 24 h after the residual test substance removed, purple-red erythema and eschar were observed in one of these three animals at 48h, and recovered at the 12th day, the skin irritations of other 2 animals alleviated and recovered during 72h to the 4th day. No skin irritation was observed in the other animal during the observation period.
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