Registration Dossier
Registration Dossier
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EC number: 250-465-0 | CAS number: 31098-20-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Jul - 03 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- the test substance was moistened with 0.5 mL distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): the test material was moistened with 0.5 mL distilled water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the test site was covered with a 2.5 x 2.5 cm cotton gauze patch that was held in place with a strip of surgical adhesive tape. The trunk of the rabbits was then wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing: the test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system. The test sites were examined 1, 24, 48 and 72 hours after the exposure ended.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- There were no skin irritation effects observed in any of the animals at reference time points 1, 24, 48 and 72 h. All scores for erythema and edema were 0 at all reference time points.
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 was not irritating to the skin of New Zealand White rabbits.
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