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EC number: 438-940-2 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 - 19 Dec 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 438-940-2
- EC Name:
- -
- Cas Number:
- 56992-87-1
- Molecular formula:
- C10 H12 N2 O3 S
- IUPAC Name:
- 2-methyl-N-(4-sulfamoylphenyl) prop-2-enamide
- Test material form:
- other: powder aggregated into lumps
- Details on test material:
- - Name of test material (as cited in study report): SPM-N
- Physical state: white lumps with powder
- Lot/batch No.: T-9314
- Expiration date of the lot/batch: 29 Aug 2008
- Storage condition of test material: at room temperature in the dark
- Other: pH 7.6-7.5 (1% in water, indicative range)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 263 ± 11 g (mean ± SD, males); 189 ± 5 g (mean ± SD, females)
- Housing: during the study period, animals were housed individually in labelled Macrolon cages (MII type; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). During the acclimatisation period, animals were housed in groups in Macrolon type MIV cages.
- Diet: pelleted rodent diet SM R/M-Z (SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0-21.7
- Humidity (%): 40-59
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 5 Dec 2007 To: 19 Dec 2007
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: the test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), covered with aluminium foil, which was covered with Coban elastic bandage. A piece of Micropore tape was additionally used to fix the wrapping in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was cleaned of residual test substance using tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Concentration: 200 mg/mL (w/w) (calculated from 10 mL/kg bw amount and 2000 mg/kg bw)
- Constant volume or concentration used: yes
VEHICLE
- Concentration (if solution): 10 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and morbidity twice daily; the occurrence of clinical signs was recorded at periodic intervals on Day 1 (0, 2, 4 h after administration) and once daily thereafter until Day 15; body weight was recorded on Day 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- Systemic effects were observed on Day 1 up to 4 h after administration. Flat posture was observed in 2/5 males 2 and 2-4 h after dosing on Day 1, respectively, while chromodacryorrhoea was noted in 4/5 males and 1/5 females 0, 2 or 4 h after administration (see Table 1 and 2).
- Body weight:
- The body weight gains were within the normal ranges in males and females during the whole study period.
- Gross pathology:
- No substance-related findings were noted at macroscopic post mortem examination of the animals..
- Other findings:
- - Other observations: Mild local effects on the treated skin were seen throughout the study period. White staining of the skin was noted in all animals for up to 4 consecutive days in the period Day 2-5. Scales or scabs were seen in 1/5 males and 3/5 females for 1-10 consecutive days in the period Day 4-15, while focal erythema was observed in 2/5 females on Day 3 or 3-4, respectively.
Any other information on results incl. tables
Table 1: Mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Males |
||||
2000 |
0/5/5 |
0 h on Day 1 – Day 10 |
- |
0 |
Females |
||||
2000 |
0/5/5 |
0 h on Day 1 – Day 15 |
- |
0 |
Overall LD50 > 2000 mg/kg bw |
* first number = number of dead animals
second number = number of animals with systemic clinical signs
third number = number of animals used
Table 2: Overview of clinical signs and duration
Observations |
Males (time of observation) |
Females (time of observation) |
||||||||
No. |
1 |
2 |
3 |
4 |
5 |
1 |
2 |
3 |
4 |
5 |
Systemic |
||||||||||
Flat posture |
|
|
|
2-4 h, Day 1 |
2 h, Day 1 |
|
|
|
|
|
Chromodacryorrhoea (snout) |
0 h, Day 1 |
2 h, Day 1 |
4 h, Day 1 |
4 h, Day 1 |
|
4 h, Day 1 |
|
|
|
|
Treated skin |
||||||||||
Scales grading slight (1) to severe (3) |
|
|
Day 6-10 grade: 1 |
|
|
|
|
|
|
Day 12 grade: 1 |
White staining |
Day 2-5 |
Day 2-4 |
Day 2-3 |
Day 2-3 |
Day 2 |
Day 2-4 |
Day 2-4 |
Day 2-4 |
Day 2 |
Day 2 |
Scabs grading slight (1) to severe (3) |
|
|
|
|
|
|
Day 4-15 grade: 1 |
Day 5-14 grade: 1 |
|
Day 8-11 grade: 1 |
Focal erythema grading slight (1) to very severe (4) |
|
|
|
|
|
Day 3 grade: 1 |
|
|
|
Day 3-4 grade: 1 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
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