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EC number: 606-744-8 | CAS number: 213464-77-8
- 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
- Study period:
- July 15 to July 18, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- Commission Directive 92/69/EEC, (B.5)
US EPA OPPTS 870.2400
MAFF 59 Nohsan No. 4200
Deviations: none - Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- IR5878
ISO common name: Orthosulfamuron
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals:
Species and Strain: Male and Female New Zealand White rabbits
Age: 2 months
Body weight: 1.8 ÷ 2.3 kg
Housing: for the entire duration of the study the rabbits were kept in metal cages with stainless feeders.
Feed: diet “2 RB 15 GLP certificate” produced by Charles River Italia’s feed licensee Mucedola Srl, Settimo Milanese. The diet was supplemented by the Producer with vitamins and traces elements. The diet was available ad libitum to the animals. Water was distributed ad libitum to the animals
Environmental conditions:
Temperature and humidity measured during the study were 19 ± 2°C and 55 ± 10%, respectively.
Light: artificial lighting with a 12-hour circadian cycle (07:00 – 19:00).
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1g/animal
- Observation period (in vivo):
- The eyes were examined at 1,24,48 and 72 hours after the test article application. After the 24 hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
- Number of animals or in vitro replicates:
- 4 males and 2 females
- Details on study design:
- Both eyes of each experimental animal provisionally selected for the study were examined within 24 hours of testing. All these rabbits were free of eye irritation ocular defects or pre-existing corneal injury. 0.1g of the test article was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball . The lids were then gently held together for about one second in order to rpevent loss of the material. The other eye (the left eye) served as a control. At 24 hours a washout was performed following the application of one drop of sodium fluorescein.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: Conjunctivae Redness
- Run / experiment:
- Animal #9M
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Redness
- Run / experiment:
- Animal #15M
- Value:
- ca. 2
- Irritation parameter:
- other: Conjunctivae Redness
- Run / experiment:
- Animal #20M
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Redness
- Run / experiment:
- Animal #41F
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Redness
- Run / experiment:
- Animal #43F
- Value:
- ca. 2
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #9M
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #15M
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #20M
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #21M
- Value:
- ca. 2
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #41F
- Value:
- ca. 1
- Irritation parameter:
- other: Conjunctivae Chemosis
- Run / experiment:
- Animal #43F
- Value:
- ca. 2
- Other effects / acceptance of results:
- Redness score (refers to palpebral and bulbar conjunctive, excluding cornea and iris) = 0 (normal), 1 (some blood vessels hyperemic), 2 (Diffuse, crimson colour, individual blood vessels not easily discernible), 3 (Diffuse beefy red)
Chemosis score (lids and or nictitating membranes) = 0 (no swelling), 1 (any swelling above normal), 2 (obvious swelling with partial eversion of lids), 3 (swelling with lids about half closed), 4 (swelling with lids more than half closed)
Any other information on results incl. tables
|
Conjunctivae |
Cornea |
Iris |
|||||||||||||||||||||
|
Redness |
Chemosis |
Opacity |
Iritis |
||||||||||||||||||||
Rabbit No. |
9M |
15M |
20M |
21M |
41F |
43F |
9M |
15M |
20M |
21M |
41F |
43F |
9M |
15M |
20M |
21M |
41F |
43F |
9M |
15M |
20M |
21M |
41F |
43F |
Time |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 h |
1 |
2* |
1 |
2* |
1 |
2* |
1 |
1 |
1 |
2* |
2* |
2* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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
- Conclusions:
- The test article IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit eyes.
- Executive summary:
IR5878 as such was placed into the conjunctival sac of the right eye of New Zealand White rabbits (4 males and 2 females). 0.1 mg of IR5878 was applied to the eye of each animal for an exposure period of 24 hours.
IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit eyes.
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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