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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Methods used standard for the period. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Substances Act as described in the Federal Register, Section 1500.41 1973
Principles of method if other than guideline:
24 hour exposure on abraded and intact skin
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not reported

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Six male albino rabbits. No environmental conditions reported.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of DUP as supplied applied to intact skin under 1X1 double thickness gauze square.
Duration of treatment / exposure:
24h
Observation period:
48h
Number of animals:
6
Details on study design:
TEST SITE
Haskell Laboratory study
- Area of exposure: trunk and lateral areas; area of 1" X 1" used
- % coverage: Not reported
- Type of wrap if used: double thickness gauze square covered by rubber sheeting which was loosely wrapped around the trunk and secured with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: 24h

SCORING SYSTEM: according to the system of the Federal Substances Act as described in the Federal Register, Section 1500.41 1973 A

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: 1/6
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: numerical score = mild, assigned, based on current OECD 404
Irritation parameter:
edema score
Basis:
other: 6/6
Time point:
other: 24h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
other: numerical score = mild, assigned, based on current OECD 404
Irritation parameter:
erythema score
Basis:
other: 4/6
Time point:
other: 48h
Score:
1
Max. score:
1
Reversibility:
other: N/A
Remarks on result:
other: numerical score = very slight, assigned, based on current OECD 404
Irritation parameter:
edema score
Basis:
other: 6/6
Time point:
other: 48h
Score:
0
Max. score:
0
Reversibility:
other: N/A
Remarks on result:
other: numerical score = no oedema, assigned, based on current OECD 404
Irritant / corrosive response data:
DUP produced mild-very slight erythema when applied to the intact skin of rabbits
Other effects:
Not reported

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
An assessment of dermal irritation in the rabbit following 24 hours exposure resulted in only slight erythema.
Executive summary:

An assessment of dermal irritation in the rabbit following 24 hours exposure according to FHSA test methods resulted in only slight erythema.