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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:
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:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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 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).