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Toxicological information

Skin irritation / corrosion

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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:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
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

Constituent 1
Chemical structure
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-(acryloyloxy)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

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 (e.g. ad libitum): 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 (if done): 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:
CLP: not classified