Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Consumer Product Safety Commission (Code of Federal Regulations, Title 16, Section1500.41)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: 0.5% aqueous gum tragacanth, containing 0.05% anhydrous sodium sulphite (Na2SO3)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 2.5%(w/v)suspension
Number of animals:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary irritation index
Score:
0.2
Remarks on result:
other: mildly irritant
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: data provided as primary index value
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: data provided as primary index value
Irritant / corrosive response data:
The treatment led to slight edema of both the intact and abraded site in one rabbit at 24hr after application indicating very mild skin irritancy.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
4-aminophenol was slightly irritant to rabbit skin based on US Consumer Product Safety Commission criteria.