Registration Dossier
Registration Dossier
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EC number: 220-120-9 | CAS number: 2634-33-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one
- EC Number:
- 220-120-9
- EC Name:
- 1,2-benzisothiazol-3(2H)-one
- Cas Number:
- 2634-33-5
- Molecular formula:
- C7H5NOS
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Proxel Press Paste
BX228, CofA Reference 9211301
Purity 74.3%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Weight 3587-4825 g.
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Controls:
- other: each animal serves as its own control
- Amount / concentration applied:
- Concentration in vehicle: 1 g/ml
Total volume applied 0.5 ml - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- The animals were assessed for up to 4 days
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight or well defined erythema was present on the application sites of all animals for up to and including Day 2 or 3.Very slight oedema was present on 5 of the 6 animals after decontamination. This persisted in 2 animals for a further 2 or 3 days.
Applicant's summary and conclusion
- Conclusions:
- Materials and methods
A sample of PROXEL Press Paste was assessed for its skin irritation potential according to US EPA PAG 81-5.
A group of six male rabbits received a single four-hour application of 500 mg (moistened with 0.5 mL water) of the test sample to the shorn flank. The animals were assessed for up to 4 days for any signs of skin irritation.
Results and discussion
Following a single four-hour application, very slight or well defined erythema was present on the application sites of all animals for up to and including Day 2 or 3. Very slight oedema was present on 5 of the 6 animals after decontamination. This persisted in 2 animals for a further 2 or 3 days. No other signs of irritation were seen.
Conclusion
PROXEL Press Paste was a slight irritant to rabbit skin, following a single four-hour application. - Executive summary:
A study was conducted to determine the skin irritation potential of the substance in rabbits according US EPA Guideline OPP 81 -5. A group of six male rabbits received a single four-hour application of 500 mg (moistened with 0.5 mL water) of the test sample to the shaved flank. The animals were assessed for up to 4 days for any signs of skin irritation. Very slight or well defined erythema was observed on the application sites of all animals up to Day 2 or 3. Very slight oedema was present on 5 of the 6 animals, which persisted in 2 animals till Day 3. No other signs of irritation were seen. Under the study conditions, the substance was not considered to be irritating to rabbit skin (Robinson, 1993).
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