Registration Dossier
Registration Dossier
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EC number: 213-758-4 | CAS number: 1008-72-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines, not GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 2-formylbenzenesulphonate
- EC Number:
- 213-758-4
- EC Name:
- Sodium 2-formylbenzenesulphonate
- Cas Number:
- 1008-72-6
- Molecular formula:
- C7H5NaO4S
- IUPAC Name:
- Sodium 2-formylbenzenesulfonate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HC: NZW, Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average weight for each animal: about 3 kg.
- Housing: in air-conditions room in individual cages
- Diet: ad libitum
- Water: ad libitum (drinking water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 40-50 %
- Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day (artificial light from 7 till 19 h).
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- other: water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material dissolved in water
- Duration of treatment / exposure:
- Substance was applied for 4h with a dressing then dressing was removed and the treated zone was washed with water.
- Observation period:
- 7 days. The effects were recorded after 1h, 24h, 48h and till 7 days after treatment.
- Number of animals:
- 3 albino rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 X 6 cm (one flank)
- % coverage: 2.5 x 2.5 cm (gauze)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 h of exposure
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): observation after 1, 24, 48, 72 h and then after 7 days.
SCORING SYSTEM:
- Method of calculation: DRAIZE, J.H.; The Apptaisal of Chemicals in Foods, Drugs, and Cosmetics, pp. 46 - 48. Association of Food and Drug Officials of the United States, Austin, Texas 1959). Ref. OECD Guideline No. 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal 13
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 14
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 13
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 14
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: animal 15
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The observation after 24h, 48h, 72h and 7 days showed no sign of erythema or edema for none of the three rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin irritant according to the CLP Regulation (EC n.1272/2008)
- Conclusions:
- The substance is not skin irritating according to the CLP Regulation (EC n. 1272/2008).
- Executive summary:
The substance has been tested for skin irritation on three albino rabbits.
The study was conducted according to the OECD Guideline N. 404. The exposure time of the substance was 4 hours. The observation after 24h, 48h, 72h and 7 days showed no sign of erythema or edema for none of the three rabbits. The substance is not skin irritating according to the CLP Regulation (EC n. 1272/2008).
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