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EC number: 605-293-4 | CAS number: 162568-25-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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).
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
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 (incl. QA statement)
- Remarks:
- Certified by BAM according to DIN EN 45001.
Test material
- Test material form:
- other: The test material contained 50% WS400517 in organic solvent
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Number: 3 animals,
- Average bodyweight: 3.2 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: The test material contained 50% WS400517 in organic solvent and was used after warming to 37°C
- Controls:
- not required
- Amount / concentration applied:
- After warming undiluted test material (no vehicle) to 37°C, 0.1 ml of it was instilled 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 post instillation
- Number of animals or in vitro replicates:
- 3 adult rabbits
- Details on study design:
- Eyes were evaluated for occular lesions using ultraviolet light. 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 for each animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days post instillation
- Remarks on result:
- other: Only 1 animal with corneal lesions, i.e. opacity
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridal changes were not evident during the study
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days post instillation
- Remarks on result:
- other: fully reversible in 2 animals, whereas in the other animal still grade 1 at 7 days post instillation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days post instillation
- Irritation parameter:
- other: lacrimation score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days post instillation
- Irritant / corrosive response data:
- Adverse effects on the iris were not evident during the 7-day observation period. Corneal findings (opacity and area affected, grade 1 to 2) were confined to one animal (No. 2) and occurred rather late during the observation period (from 3 to 6 days post test material instillation). By 7 days post instillation, the corneal finding was no longer evident. Conjunctival redness, chemosis and lacrimation, grade 1 to 2, were seen in all animals and had completely resolved in two animals (Nos. 1 and 3) within 5 days after instillation. In the other animal (No. 2) a trend to reversibility was evident during the observation period with chemosis and lacrimation having completely resolved and conjunctival redness, grade 1, still present by 7 days post instillation. The ocular findings in treated eyes are detailed in Table 2.
- Other effects:
- Daily determination of bodyweight did not reveal any test related changes. Bodyweight gain was normal.
Any other information on results incl. tables
Table 2: Ocular Lesions of each Animal |
||||||||||
|
|
Cornea |
|
Iris |
|
Conjunctivae |
||||
Animal |
Time after dosing |
|
Opacity (0-4) |
Area (0-4) |
|
(0-2) |
|
Redness (0-3) |
Chemosis (0-4) |
Lacrimation (0-3) |
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
1 |
1 hour |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
2 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
4 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
8 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
24 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
48 hours |
|
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
72 hours |
|
0 |
0 |
|
0 |
|
1 |
1 |
0 |
|
96 hours |
|
0 |
0 |
|
0 |
|
1 |
0 |
0 |
|
5 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
6 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
7 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
2 |
1 hour |
|
0 |
0 |
|
0 |
|
1 |
1 |
1 |
|
2 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
4 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
8 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
24 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
48 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
72 hours |
|
2 |
2 |
|
0 |
|
2 |
2 |
1 |
|
96 hours |
|
2 |
2 |
|
0 |
|
2 |
2 |
1 |
|
5 days |
|
2 |
2 |
|
0 |
|
1 |
1 |
0 |
|
6 days |
|
1 |
1 |
|
0 |
|
1 |
0 |
0 |
|
7 days |
|
0 |
0 |
|
0 |
|
1 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
3 |
1 hour |
|
0 |
0 |
|
0 |
|
1 |
1 |
1 |
|
2 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
4 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
8 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
2 |
|
24 hours |
|
0 |
0 |
|
0 |
|
2 |
2 |
1 |
|
48 hours |
|
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
72 hours |
|
0 |
0 |
|
0 |
|
2 |
1 |
0 |
|
96 hours |
|
0 |
0 |
|
0 |
|
1 |
0 |
0 |
|
5 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
6 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
7 days |
|
0 |
0 |
|
0 |
|
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating, see explanation in conclusion
- Remarks:
- expert judgment
- Conclusions:
- According to European classification rules [REGULATION (EC) 1272/2008] the degree and incidence of conjunctival redness seen in the present study could lead to classification as an eye irritant Category 2. However, the material tested in the present study contained a substantial amount of at least one formulation constituent classified as skin and eye irritant Category 2 [REGULATION (EC) 1272/2008]. Therefore and because of the absence of any relevant toxicity or indication of an irritating potential in all other toxicity studies performed with neat WS400517 or with any of its formulations, the eye irritation seen in the present study is attributed to the irritating formulation constituent and not to WS400517. Consequently, it is proposed not to classify WS400517 as an eye irritant according to EU classification rules [REGULATION (EC) 1272/2008].
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.
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