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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
Skin (OECD 404): not irritating (0.5 g, rabbit, semi-occlusive, 4 h)
Eye (OECD 405): not irritating (0.1 mL/44 mg, rabbit, single application without washing)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Oct - 2 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- adopted Aug 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, the Netherlands
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 1.44-1.62 kg
- Housing: animals were housed individually in cages (56 cm x 44 cm x 37,5 cm) with perforated floors (Scanbur, Denmark)
- Diet: K-H pelleted diet for rabbits (SSNIFF Spezialdiäten GmbH, Soest, Germany), approximately 100 g/day. Hay (Technilab-BMI BV, Someren, the Netherlands) was provided at least 3 times/week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4-22.4
- Humidity (%): 45-61%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 Oct 2007 To: 2 Nov 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated sites of the animals served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.5 mL
(0.5 g test substance was moistened with 0.5 mL vehicle before application)
The test material was ground to a powder using a pestle and mortar prior to weighing. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² on the dorsal area
- Type of wrap if used: the test substance was applied to a metalline patch (2 cm x 3 cm), which was mounted on Micropore tape that was wrapped around the abdomen and secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was removed from the skin using tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- No erythema or edema was recorded in any of the animals at any reading time point.
- Other effects:
- There was no mortality, no clinical signs were observed and the body weight was within the normal range during the study period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Oct - 16 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted Aug 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, the Netherlands
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 2.02-2.10 kg
- Housing: animals were housed individually in cages (56 cm x 44 cm x 37,5 cm) with perforated floors (Scanbur, Denmark)
- Diet: K-H pelleted diet for rabbits (SSNIFF Spezialdiäten GmbH, Soest, Germany), approximately 100 g/day. Hay (Technilab-BMI BV, Someren, the Netherlands) was provided at least 3 times/week.
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9-22.6
- Humidity (%): 44-56%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 Oct 2007 To: 16 Nov 2007 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required: the untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 44.0 mg (range 36.9-47.7 mg) (corresponding to a volume of approximately 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein was instilled in the eyes immediately after the 24 h reading and the corneal epithelial damage assessed with a slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- Conjunctival redness (score 2) was observed in 3/3 animals 1 h after instillation. The redness persisted in 3/3 animals (score 1) until the 48 h reading time point. Chemosis (score 1-2) was observed in 3/3 animals and iridial irritation (score 1) was seen in 2/3 animals at the 1 h reading time point. Both effects had cleared completely by the 24 h reading. All effects were completely reversible within 72 h.
Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals. - Other effects:
- There was no mortality, no clinical signs were observed and the body weight was within the normal range during the study period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1: individual irritation scores
Rabbit #
|
Time
|
conjunctivae
|
iris
|
cornea
|
|
redness |
chemosis |
||||
1
|
1 h1 |
2 |
1 |
1 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.67 |
0.0 |
0.0 |
0.0 |
|
2
|
1 h1 |
2 |
2 |
0 |
0 |
24 h2 |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.67 |
0.0 |
0.0 |
0.0 |
|
3
|
1 h1 |
2 |
1 |
1 |
0 |
24 h |
1 |
0 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
|
Average* |
0.67 |
0.00 |
0.0 |
0.0 |
* mean of 24 + 48 + 72 h
1Remains of test substance in the eye
2Remains of the test substance on the outside of the eyelids
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
To assess the skin irritation potential of 2-methyl-N-(4-sulfamoylphenyl) prop-2-enamide (SPM-N), a study was performed according to OECD Guideline 404 and under GLP conditions (Stitzinger, 2008c). 0.5 g test substance, moistened with 0.5 mL water, was applied to the clipped skin of New Zealand White rabbits under semi-occlusive conditions for 4 h. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. There were no skin irritation effects observed in any of the animals at any reading time point.
In the acute dermal toxicity study, SPM-N (in propylene glycol) at a dose of 2000 mg/kg bw was applied to the clipped skin of rats under occlusive conditions for 24 h (Stitzinger, 2008b). White staining of the skin was noted in all animals for up to 4 consecutive days in the period Day 2-5. Slight scales or scabs were seen in 1/5 males and 3/5 females for 1-10 consecutive days during Day 4-15, while focal erythema of grade 1 was observed in 2/5 females on Day 3 or 3-4, respectively.
The skin irritation study, performed according to the standard test for the hazard assessment and classification (OECD Guideline 404 with 4 h exposure period under semi-occlusive conditions) did not result in skin irritation. The longer exposure period (24 h) employed in the acute dermal toxicity study shows that even under more rigorous conditions the test substance does not cause skin irritation that leads to a classification. Therefore, SPM-N is considered not to be a skin irritant.
Eye
The eye irritation potential of SPM-N was evaluated in a study performed according to OECD Guideline 405 and in compliance with GLP (Stitzinger, 2008d). An average of 44 mg (weight corresponds to 0.1 mL) was instilled into one eye each of 3 male New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after the treatment. Remains of the test substance were noted in the treated eye of 3/3 animals on Day 1, while remains were present on the outside of the eyelids on Day 2 in 1/3 animals.
Chemosis (score 1-2) was observed in 3/3 animals and iridial irritation (score 1) was seen in 2/3 animals at the 1 h reading time point, but both had cleared completely by the 24 h reading time point. Conjunctival redness (score 2) was observed in 3/3 animals 1 h after instillation. The redness persisted in 3/3 animals until the 48 h reading time point, but was completely reversed by the following scoring time. The mean score for conjunctival redness after 24, 48, and 72 h was 0.67 for each of the 3 animals. The effects on cornea, iris and chemosis after 24, 48, and 72 h were scored 0 for all 3 animals. Based on the results of this study, SPM-N is considered not to be an eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.
Justification for selection of eye irritation endpoint:
There is only one study available.
Justification for classification or non-classification
The available data on skin and eye irritation 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.
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