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Diss Factsheets
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EC number: 605-296-0 | CAS number: 162627-17-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Tattooed New Zealands (albino rabbit)
- Details on test animals or tissues and environmental conditions:
- - Number: 6 animals,
- Bodyweight: 2.5 to 3.0 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
Prior to dosing the animals were starved for 16 hours.
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.
Test system
- Vehicle:
- other: CMC (carboxymethyl cellulose "Tylose") containing 40% test substance
- Controls:
- not required
- Amount / concentration applied:
- Undiluted test substance could not be administered. Therefore, a dose formulation was prepared containing 40.5% WS400130.
After warming this test substance dilution to 40°C, 0.1 ml of it was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control. - Duration of treatment / exposure:
- There was no mentioning in the report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 7 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- 7 days (i.e. the final observation time point was 7 days post instillation)
- Number of animals or in vitro replicates:
- 6 adult rabbits
- Details on study design:
- Eyes were evaluated for occular lesions using ultraviolet light. Before and after the test the eyes of all animals were examained after staining with 2% fluorescein thus supporting the recognition of corneal lesions.
The numerical scoring system listed in Table 1 in the field below was adopted. Time points of evaluation were: Pretest (prior to treatment), 1, 2, 4, 8, 24, 48, 72 and 96 hours after administration and daily thereafter until 7 days after administration. Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Remarks on result:
- other: Treated with a dose formulation containing 40.5% WS400130
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridal changes were not evident during the study
- Remarks on result:
- other: Treated with a dose formulation containing 40.5% WS400130
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 hours
- Remarks on result:
- other: Treated with a dose formulation containing 40.5% WS400130
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Chemosis was not evident during the study
- Remarks on result:
- other: Treated with a dose formulation containing 40.5% WS400130
- Irritation parameter:
- other: lacrimation score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 hours
- Remarks on result:
- other: Treated with a dose formulation containing 40.5% WS400130
- Irritant / corrosive response data:
- Corneal and iridic lesions and chemosis were not evident throughout the study. Conjunctival redness and lacrimation, both findings grade 1, were seen in all treated eyes at 1 and 2 hours post instillation having completely disappeared in all animals by 4 hours post instillation. Examination of the eyes at 4 and 8 hours post instillation and daily afterwards until 7 days post instillation did not reveal any findings.
- Other effects:
- There was no mentioning of any other effects in the report.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to EU regulation
- Conclusions:
- WS400130 could not be administered undiluted. Therefore, a dilution in CMC (Tylose) containing 40.5% WS400130 was tested. The outcome of the present study does not necessitate any labelling regarding eye irritation according to EU classification rules [REGULATION (EC) 1272/2008]. The findings noted were very minor in degree, restricted to the 1 and 2 hour post instillation time points and fully reversible within 4 hours. Therefore, they fell within the category “not irritating to eyes”.
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