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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test done before GLP and Guidelines were established.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Hazardous Substances and Articles, Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino rabbits

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact / abraded
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
six

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no observation at 48 h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no observation at 48 h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no observation at 48 h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal: 1-6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no observation at 48 h

Any other information on results incl. tables

Rabbit Number
Erythema and Eschar Formation Reading (Hours) 1 2 3 4 5 6 Average
Intact Skin 24 1 1 1 1 1 1 1.00
Intact Skin 72 0 0 0 0 0 0 0.00
Abraded Skin 24 1 1 1 1 1 1 1.00
Abraded Skin 72 0 0 0 0 0 0 0.00
Subtotal 2.00
Edema Formation
Intact Skin 24 0 0 0 0 0 0 0.00
Intact Skin 72 0 0 0 0 0 0 0.00
Abraded Skin 24 0 0 0 0 0 0 0.00
Abraded Skin 72 0 0 0 0 0 0 0.00
Subtotal 0.00
Primary Irritation Score: 2.00 : 4 =0.50 Total 2.00

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
THE SUBJECT MATERIAL WOULD NOT BE CLASSIFIED AS A PRIMARY IRRITANT TO ALBINO RABBITS WITHIN THE DEFINITION OF THE ACT REFERENCE: SECTION 1500.3 AND REQUIRES NO CAUTIONARY LABELING WITH RESPECT TO THAT SECTION.
Executive summary:

THE SUBJECT MATERIAL WOULD NOT BE CLASSIFIED AS A PRIMARY IRRITANT TO ALBINO RABBITS WITHIN THE DEFINITION OF THE ACT REFERENCE: SECTION 1500.3 AND REQUIRES NO CAUTIONARY LABELING WITH RESPECT TO THAT SECTION.