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Administrative data

Description of key information

Studies conducted to standards in place at the time of the study for skin and eye irritation were conducted.  Studies found slight to no effects on the skin and slight reversible irritation on the eye. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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.
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
Species:
rabbit
Strain:
New Zealand White
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
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.
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.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Protocols followed based on OECD and cosmetic irritation protocols; no confirmation of GLP
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
also applied Official French Cosmetic (OFC) method
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g applied under occlusive and semi-occlusive conditions
Duration of treatment / exposure:
4 hours or at 23 hours
Observation period:
48 hours
Number of animals:
6 / group
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all
Score:
>= 0
Max. score:
8
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

4 -aminophenol was not irritating according to CLP classification guidelines for these endpoints.