Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2014-12-09 to 2014-12-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 21609-2008 Chemicals - Test method of acute eye irritation/corrosion
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- authorized by CNAS
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Purity: 100.0%
- Lot No.: KNC110310
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Tianqin biotechnology Ltd., Changsha
- Weight at study initiation: 2.0 ~ 2.3 kg
- Housing: housed in common environment
- Diet: All ofthe feeds were supplied by Tianqin Biotechnology Ltd., Changsha
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 57-62
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Observation period (in vivo):
- 4 day
- Number of animals or in vitro replicates:
- 2 female and 2 male
- Details on study design:
- - Treatment of the test substance: An appropriate amount of the test substance was grinded
- Exposure: The animal left eyelid was opened lightly, and about 100 mg of the test substance was applied on the cornea, the lids are then gently held together for one second.
- Observation: The eyes were examined at 1h, 24h, 48h, 72 h and the 4th day, and the scores were recorded.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: All 4 animal tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: all 4 animal tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- One hour after administration, the conjunctiva of the rabbits signed No.1 and No.2 were cardinal red congestion and light dropsy and having more excretion. The conjunctiva of the rabbits signed No.3 and No.4 were bright red congestion and light dropsy and having a small amount excretion. Twenty-four hours after administration, the conjunctiva of the rabbits signed No.2 and No.4 were cardinal red congestion and light dropsy and having a great quantity excretion. The dropsy of the conjunctiva of the rabbits signed No.1 and No.3 disappeared. Forty-eight hours after administration, the irritation of the four rabbits lightened. And the eye of the rabbits signed No.1, No.3 and No.4 recovered in the time of 72 h after administration. The eye of the rabbits signed No.2 recovered in the time of the 4th day. The irritation of Cornea and Iris were not observed.
- Other effects:
- Individual body weights were rising after exposing.
Any other information on results incl. tables
Eye Damage and Scoring:
|
Female #1 |
Female #2 |
Male #3 |
Male #4 |
||||||||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|
cornea opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
2 |
1 |
1 |
0 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
2 |
1 |
0 |
chemosis |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified
- Conclusions:
- The mean cornea opacity and iris scores at 24, 48 and 72 h for each animal were all 0. The mean conjunctivae scores were 0.67, 1.33, 0.33, 1 and the mean chemosis scores were 0, 1, 0, 0.33, respectively at 24, 48 and 72 h after installation. All the irritations disappeared within 4 days.
- Executive summary:
The irritation/corrosion effects of the test substance on eyes of rabbit were assessed in accordance with GB/T 21609-2008 Chemicals - Test method of acute eye irritation/corrosion.
100 mg of the test substance was applied on the left cornea of 2 female and 2 male White New Zealand rabbits. The untreated right eye was used as control.
The mean cornea opacity and iris scores at 24, 48 and 72 h for each animal were all 0. The mean conjunctivae scores were 0.67, 1.33, 0.33, 1 and the mean chemosis scores were 0, 1, 0, 0.33, respectively at 24, 48 and 72 h. All the irritations disappeared within 4 days.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Iako ECHA većinu materijala na ovim stranicama osigurava na vašem jeziku, dio ove stranice samo je na engleskom. Dodatne informacije o politici višejezičnosti ECHA-e.
Dobro došli na stranice ECHA-e Ove stranice ne podržavaju potpuno Internet Explorer 7 (i njegove ranije inačice). Preuzmite noviju inačicu Internet Explorera.
Na ovom portalu koristimo kolačiće kako bismo vam osigurali najbolje iskustvo njegova pregledavanja.
Saznajte više o tome kako upotrebljavamo kolačiće.