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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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value, limit test)
Dermal (OECD 402), rat: LD50 ≥ 2000 mg/kg bw (limit test)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 - 31 Oct 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted 2002
- 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:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar Crl:WI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 214-242 g (range)
- Fasting period before study: maximum 20 hrs prior to the administration until 3-4 hrs after administration
- Housing: animals were housed in groups of 3 animals per cage in labelled Macrolon cages (MIV 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)
- 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): 21.1-23.2
- Humidity (%): 26-63
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 Oct 2008 To: 31 Oct 2008 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the testing laboratory and on test substance data supplied by the sponsor
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 per step)
- 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 hrs 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 - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: According to OECD 423, the LD50 cut-off is set at 5000 mg/kg bw based on a limit test with 2000 mg/kg bw, since no mortality occurred in any step.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- A hunched posture was observed in 6/6 rats 2 h after dosing. 3/6 animals had piloerection and the remaining 3/6 rats had slight uncoordinated movements from dosing until 4 h after administration. Slight alopecia was noted 2/6 animals from Day 9 or 10 until the end of the study period.
- Body weight:
- No effect on body weight was noted.
- Gross pathology:
- No substance-related findings were noted during macroscopic post mortem examination.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1: Mortality and clinical signs
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Females |
||||
2000 |
0/6/6 |
0-4 h on Day 1, Day 9-15 |
- |
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- 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
- 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 - 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 - 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.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Oral
In a study performed according to the acute toxic class method (OECD Guideline 423), 2-methyl-N-(4-sulfamoylphenyl) prop-2-enamide (SPM-N) in propylene glycol was administered via gavage to two subsequent groups of 3 female Wistar rats at the limit dose of 2000 mg/kg bw (Stitzinger, 2008a). No mortality occurred within the 14-day observation period. A hunched posture was observed in 6/6 rats 2 h after dosing. 3/6 animals had piloerection and the remaining 3/6 rats had slight uncoordinated movements from dosing until 4 h after administration. The body weight was not affected during the observation period and no substance-related findings were noted during macroscopic post-mortem examination. According to OECD Guideline 423, Annex 2d, a cut-off value of 5000 mg/kg bw was derived, since no mortality occurred in any step at the limit dose of 2000 mg/kg bw.
Dermal
The acute dermal toxicity of SPM-N was assessed in a limit test performed according to OECD Guideline 402 and under GLP conditions (Stitzinger, 2008b). A single dose of 2000 mg/kg bw of the test substance in propylene glycol was applied to the shaved skin of 5 rats/sex/dose under occlusive conditions for 24 h. There was no mortality and no effects on body weight were noted during the 14-day observation period. Clinical signs were observed on Day 1 up to 4 h after administration: flat posture was observed in 2/5 males, while chromodacryorrhoea was noted in 4/5 males and 1/5 females 0, 2 or 4 h after administration. The necropsy and gross pathological examination did not reveal any treatment-related effects. Slight local effects on the treated skin area were seen throughout the study period. White staining of the skin was noted in all animals for up to 4 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. The LD50 value for systemic toxicity is considered to be > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
There is only one study available.
Justification for selection of acute toxicity – inhalation endpoint
The acute inhalation toxicity study is not required as no inhalation exposure is expected taking into account the physico-chemical properties and the conditions of use.
Justification for selection of acute toxicity – dermal endpoint
There is only one study available.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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