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EC number: 250-465-0 | CAS number: 31098-20-1
- 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:
- 07 - 22 Aug 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
Test material
- Reference substance name:
- Potassium 3-sulphonatopropyl acrylate
- EC Number:
- 250-465-0
- EC Name:
- Potassium 3-sulphonatopropyl acrylate
- Cas Number:
- 31098-20-1
- Molecular formula:
- C6H10O5S.K
- IUPAC Name:
- potassium 3-(prop-2-enoyloxy)propane-1-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): SPA, sulfopropyl acrylate
- Physical state: white powder
- Analytical purity: no data
- Lot/batch No.: 0200014/001
- Storage condition of test material: room temperature, in the dark
-pH: 5.4 in a 10% w/w aqueous solution
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: animals were individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, weighing approximately 88 mg - Duration of treatment / exposure:
- The treated eye was not washed
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48 and 72 h, and 7 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Initially, 1 animal was treated. After assessing the ocular response in the first animal, 2 additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic (Amethocaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of these animals 1-2 minutes before treatment.
The test substance was placed into the conjunctival sac of the right eye and the upper and lower lids were then held together for 1 second to prevent loss of the test substance. The left eye remained untreated and was used as a control. Immediately after the treatment, the pain reaction was assessed using a 6 point scale. Assessment of ocular damage was made approximately 1, 24, 48 and 72 hours and 7 days after treatment.
REMOVAL OF TEST SUBSTANCE
- Washing: the eye was not washed after treatment
SCORING SYSTEM: Draize scoring system.
TOOL USED TO ASSESS SCORE: opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- A dulling of the normal lustre of the cornea was noted in all treated eyes at the 1-hour time point. Diffuse corneal opacity was noted in two treated animals 24 hours after treatment and in one animal at the 48-hour time point. Iridial inflammation was seen in all treated eyes at the 1- and 24-hour time point, persisting in one eye until the 48-hour observation. Moderate conjuntival irritation was observed in all treated eyes after 1, 24 and 48 hours, with minimal to moderate irritation still present at the 72-hour time point. Areas of haemorrhage (approximately 2 mm x 2 mm) were noted on the nictitating membrane on one animal at the 24, 48 and 72-hour observations. All treated eyes were normal within 7 days.
Any other information on results incl. tables
Table 1. Individual results of the eye irritation study. |
||||||||||
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
|
conjunctivae |
|
iris |
cornea |
redness |
swelling |
redness |
swelling |
|
|
|||||
1 |
1 |
2 |
2 |
1 |
0 d |
|
||||
24 |
2 H |
2 |
1 |
1 |
||||||
48 |
2 H |
2 |
1 |
1 |
||||||
72 |
2 H |
2 |
0 |
0 |
||||||
7 d |
0 |
0 |
0 |
0 |
||||||
average |
2 |
2 |
0.67 |
0.67 |
Time to reversion |
7 d |
7 d |
72 h |
72 h |
|
2 |
1 |
2 |
2 |
1 |
0 d |
|
|
|||
24 |
2 |
2 |
1 |
1 |
||||||
48 |
2 |
1 |
0 |
0 |
||||||
72 |
1 |
1 |
0 |
0 |
||||||
7 d |
0 |
0 |
0 |
0 |
||||||
average |
1.67 |
1.33 |
0.33 |
0.33 |
Time to reversion |
7 d |
7 d |
48 h |
48 h |
|
3 |
1 |
2 |
2 |
1 |
0 d |
|
|
|||
24 |
2 |
2 |
1 |
0 |
||||||
48 |
2 |
1 |
0 |
0 |
||||||
72 |
1 |
1 |
0 |
0 |
||||||
7 d |
0 |
0 |
0 |
0 |
|
|
|
|
||
average |
1.67 |
1.33 |
0.33 |
0.0 |
Time to reversion |
7 d |
7 d |
48 h |
24 h |
Average = mean of 24 + 48 + 72 h scores
d: dulling of the normal lustre
H: area of haemorrhage (app. 2 mm x 2 mm) on the nictating membrane
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the study, the test substance induced some mild irritancy to the eye of New Zealand White rabbits. However, the slight signs of irritation observed were fully reversible after 7 days and were not sufficient to warrant classification for eye irritation.
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