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EC number: 617-298-9 | CAS number: 82097-50-5
- 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:
- 18 Jul 2012 to 23 Jul 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 2004/73/EC B.5 (L 152 2004)
- Version / remarks:
- 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
- EC Number:
- 617-298-9
- Cas Number:
- 82097-50-5
- Molecular formula:
- C14H16ClN5O5S
- IUPAC Name:
- 2-(2-chloroethoxy)-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoyl]benzene-1-sulfonamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Age at study initiation: Approximately 12 weeks
- Weight at study initiation: 3110– 3328 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: UNI diet for rabbits. Ad libitum
- Water: Tap water. Ad libitum
- Acclimatisation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 48 – 73 %
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12 hours of light/12 hours of dark
IN-LIFE DATES: From: 18 July 2012 To: 23 July 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- The test item was administered as an instillation of a single dose
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PRE-STUDY EXAMINATION
- The pH of the test material was measured as pH 5.0, permitting the test material to be used in the animal studies.
- The test was performed on 3 male rabbits. Before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect using a hand-held slit-lamp. Only animals free of ocular damage were used. The eyes were not anaesthetised.
APPLICATION
The test material was placed into the conjunctival sac of the left eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for several seconds immediately after treatment, to prevent loss of the test material
OBSERVATION TIME POINTS
Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 hours following treatment. The eyes were further examined using 2% fluorescein solution approximately 24 hours before treatment and then 24, 48 and 72 hours after treatment
SCORING SYSTEM:
The eye irritation scores were evaluated according to the scoring system by Draize (1977). A modified version of the system described by Kay J H and Calandra J C (1962) was used to classify the ocular irritancy potential of the test material. For criteria, see 'Any other information on materials and methods incl. tables'.
TOOL USED TO ASSESS SCORE: fluorescein
OTHER OBSERVATIONS
- Individual body weight was recorded at dosing and at termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other:
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- An Initial Pain Reaction (IPR) score of 2 was observed in all animals.
Conjunctival redness (score 2) was seen in all rabbits and conjunctival discharge (score 1) was observed in two animals at 1 hour after treatment. Conjunctival discharge had reversed in all animals at the 24 hour observation. Conjunctival redness had reversed at the 72 hours observation.
Fluorescein staining was negative in all animals at any time point.
As all signs of eye irritation had fully reversed, the study was terminated after a period of 72 hours observation. - Other effects:
- - The body weights of all rabbits were considered to be within the normal range of variability.
- No clinical signs of systemic toxicity were observed in any animals in this study.
- No mortality occurred in this study.
Any other information on results incl. tables
Table 3. Individual Draize Scores and Individual Total Scores* for Ocular Irritation
Rabbit number and sex |
| Male #1 |
| Male #2 | Male #3 |
| ||||||
| IPR = 2 |
|
| IPR = 2 |
|
| IPR = 2 |
| ||||
Time after treatment | 1 Hr | 24 Hr | 48 Hr | 72 Hr | 1 Hr | 24 Hr | 48 Hr | 72 Hr | 1 Hr | 24 Hr | 48 Hr | 72 Hr |
CORNEA E = Degree of Opacity F = Area of Cornea involved |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
* Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS D = Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2 0 0 |
1 0 0 |
0 0 0 |
0 0 0 |
2 0 1 |
1 0 0 |
1 0 0 |
0 0 0 |
2 0 1 |
1 0 0 |
1 0 0 |
0 0 0 |
* Score (A+B+C) x 2 | 4 | 2 | 0 | 0 | 6 | 2 | 2 | 0 | 6 | 2 | 2 | 0 |
* Total Score | 4 | 2 | 0 | 0 | 6 | 2 | 2 | 0 | 6 | 2 | 2 | 0 |
IPR: Initial pain reaction
Hr: Hour(s)
* Kay J H and Calandra J C (1962)
Table 4. Individual Total Scores and Group Mean Scores for Ocular Irritation Calculated from the Draize Scores
Rabbit Number and Sex | * Individual Total Scores At: | |||
1 Hour | 24 Hours | 48 Hours | 72 Hours | |
Male #1 | 4 | 2 | 0 | 0 |
Male #2 | 6 | 2 | 2 | 0 |
Male #3 | 6 | 2 | 2 | 0 |
* Group Total | 16 | 6 | 4 | 0 |
* Group Mean Score | 5.33 | 2.00 | 1.33 | 0.00 |
*: Kay J H and Calandra J C (1962)
Table 5. Individual Fluorescein Staining
Rabbit Number and Sex | Fluorescein Staining | |||
24 Hours Prior to Instillation | 24 Hours After Instillation | 48 Hours After Instillation | 72 Hours After Instillation | |
Male #1 | - | - | - | - |
Male #2 | - | - | - | - |
Male #3 | - | - | - | - |
- : Absence of Fluorescein Stain
Table 6. Individual Bodyweights and Bodyweight Change
Rabbit Number and Sex |
Individual Bodyweight (g) |
Bodyweight Change (g) | |
Before treatment | End of experiment | ||
Male #1 | 3328 | 3389 | 61 |
Male #2 | 3251 | 3307 | 56 |
Male #3 | 3110 | 3176 | 66 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.
- Executive summary:
In an OECD TG 405 primary eye irritation study, performed under GLP, 0.1 g of the test item was instilled into the conjunctival sac of the left eye of each of 3 adult male New Zealand White rabbits. The untreated right eyes served as the control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test material instillation. Observations with fluorescein staining were made approximately 24 hours before treatment and then 24, 48 and 72 hours after treatment.
No mortality occurred during the study. An Initial Pain Reaction (IPR) score of 2 was observed in all animals.
The average cornea opacity, iris and chemosis score of all three animals over 24, 48 and 72 hours was 0. The average conjunctivae score of animal #1 at 24 h was 0.33 (redness), fully reversible within 48 h. The average conjunctivae score of animal #2 and #3 at 48 h was 0.67 (redness), fully reversible within 72h.
Fluorescein staining was negative in all animals at all time points. As all signs of eye irritation had fully reversed, the study was terminated after a period of 72 hours observation. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The test item was graded as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system.Under the condition of this study and according to GHS criteria, the test substance was considered not to be irritating to the eyes of rabbits.
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