Registration Dossier
Registration Dossier
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EC number: 250-465-0 | CAS number: 31098-20-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 - 20 Aug 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom
- Test type:
- standard acute method
- Limit test:
- yes
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl: CD(SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 206-226 g (females) and 191-232 (males). One male weighed less than the 200 g specified in the Standard Test Method, but this was not considered to have affected the integrity of the study.
- Fasting period before study: no
- Housing: animals were housed individually during the exposure period and in groups of 5 by sex for the remainder of the study; in suspended polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse SQC Expanded diet No.1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- the test substance was moistened with distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: a shorn area on the back and flank of the rats
- % coverage: 10
- Type of wrap if used: self-adhesive semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was cleaned with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for mortality and clinical signs 1/2, 1, 2 and 4 hours after dosing and then once daily for 14 days. The body weight was recorded prior to dosing, and 7 and 14 days after dosing. The test site was observed for primary irritation (erythema and edema, according to the Draize scoring system) once daily for 14 days.
- Necropsy of survivors performed: yes, the animals were subjected to gross pathological examination
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:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and gross pathological examination revealed no substance-related findings.
- Other findings:
- There were no signs of dermal irritation; all erythema and edema scores were 0.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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