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EC number: 688-332-8 | CAS number: 199119-58-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 April 1997 to 2 May 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to GLP and in line with standardised guidelines OECD 404, EU Method B.4 and EPA OPP 81-5 with no deviations thought to impact on the reliability of the presented results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: J-MAFF 59 NohSan No. 4200
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium 4,6-dimethoxy-N-({[3-(2,2,2-trifluoroethoxy)pyridin-2-yl]sulfonyl}carbamoyl)pyrimidin-2-aminide
- EC Number:
- 688-332-8
- Cas Number:
- 199119-58-9
- Molecular formula:
- C14H13F3N5O6SNa
- IUPAC Name:
- sodium 4,6-dimethoxy-N-({[3-(2,2,2-trifluoroethoxy)pyridin-2-yl]sulfonyl}carbamoyl)pyrimidin-2-aminide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: solid
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 18-24 weeks
- Weight at study initiation: 3790 - 4650 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): approximately 13-14 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From 29 April 1997 to 2 May 1997
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test material moistened with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80 to allow good skin contact. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days post administration
- Number of animals:
- 3 males, 3 females (6 animals in total)
- Details on study design:
- TEST SITE
- Area of exposure: On the day prior to application, an area approximately 10 cm wide from one flank to the other, of each animal, was shaved with an electric clipper. The test material was moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80 and applied to the test site by means of a gauze patch. A control patch, moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80, was applied to the other flank.
- Type of wrap if used: The treated area was covered with a gauze patch which was loosely covered with aluminium foil and held in place with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, the dressing was and the application site was cleansed with lukewarm water.
- Time after start of exposure: approximately 4 hours
SCORING SYSTEM:
The Draize scale (Draize 1959), was used to assess the degree of erythema and oedema at the application sites approximately 1 hour and 1, 2 and 3 days after the removal of the dressings. Any other clinical signs were also noted. Mortality was checked daily and bodyweigths were measured and recorded immediately before dose administration and at the 72 hour examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight erythema was observed in two male and two female animals 1 hour after patch removal and was still seen in one male and two females at the 24 hour observation. All skin reactions were fully reversible within 48 hours.
- Other effects:
- There were no signs of ill-health in any animal during the study and bodyweights were not affected by treatment.
Any other information on results incl. tables
Table 2: Erythema and Oedema Scores
Animal No. |
Erythema |
Oedema |
||||||||
Time after decontamination |
Mean Score |
Time after decontamination |
Mean Score |
|||||||
1 hour |
1 day |
2 days |
3 days |
1 hour |
1 day |
2 days |
3 days |
|||
755 (M) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
569 (M) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
803 (M) |
1 |
1 |
0 |
0 |
0.3 |
0 |
0 |
0 |
0 |
0 |
368 (F) |
1 |
1 |
0 |
0 |
0.3 |
0 |
0 |
0 |
0 |
0 |
410 (F) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
422 (F) |
1 |
1 |
0 |
0 |
0.3 |
0 |
0 |
0 |
0 |
0 |
The mean values have been calculated using the day 1, 2 and 3 values.
Overall mean score(erythema) 24 - 72 hours = 0.2
Overall mean score(oedema) 24 - 72 hours = 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin irritation potential of the test material was determined in accordance with standardised guidelines OECD 404, EU Method B.4 and EPA OPP 81 -5. Six rabbits (3 male and 3 female) received a single four hour application of 0.5 g of the test material and were assessed for the following 3 days for any signs of skin irritation. Very slight erythema was observed in two male and two female animals 1 hour after patch removal and was still seen in one male and two females at the 24 hour observation. All skin reactions were fully reversible within 48 hours. There were no signs of ill-health in any animal during the study and bodyweights were not affected by treatment.
Under the conditions of the study, the test material was considered to be not-irritating to the skin in the albino rabbit. The test material does not require classification for skin irritation in line with Regulation No. 1272/2008.
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