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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Amended Safety Assessment of p-Methylaminophenol Sulfate and p-Methylaminophenol
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2007
Bibliographic source:
Cosmetic Ingredient Review, 2007
Reference Type:
secondary source
Title:
Opinion on p-methylaminophenol sulfate. COLIPA no A22
Author:
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP
Year:
2006
Bibliographic source:
SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS – SCCP, COLIPA no A22, during the 7th plenary meeting of 28 March 2006
Reference Type:
secondary source
Title:
HUMAN HEALTH TIER II ASSESSMENT FOR p-Methylaminophenol and its sulfate
Author:
INVENTORY MULTI-TIERED ASSESSMENT AND PRIORITISATION (IMAP) - National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
Year:
2017
Bibliographic source:
INVENTORY MULTI-TIERED ASSESSMENT AND PRIORITISATION (IMAP) - NICNAS, 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
To assess the skin irritation potential of N-methyl-p-aminophenol sulphate in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: p-Methylaminophenol sulfate
- IUPAC name: Bis(4-hydroxy-N-methylanilinium) sulphate
- Molecular formula: C14H20N2O6S
- Molecular weight: 344.386 g/mole
- Smiles:CNc1ccc(cc1)O.CNc1ccc(cc1)O.OS(=O)(=O)O
- Inchl: 1S/2C7H9NO.H2O4S/c2*1-8-6-2-4-7(9)5-3-6;1-5(2,3)4/h2*2-5,8-9H,1H3;(H2,1,2,3,4)
- Substance type: Organic
- Physical state: Solid crystalline (off white - white)
Specific details on test material used for the study:
- Name of test material: p-Methylaminophenol sulfate- IUPAC name: Bis(4-hydroxy-N-methylanilinium) sulphate- Molecular formula: C14H20N2O6S- Molecular weight: 344.386 g/mole- Smiles:CNc1ccc(cc1)O.CNc1ccc(cc1)O.OS(=O)(=O)O- Inchl: 1S/2C7H9NO.H2O4S/c2*1-8-6-2-4-7(9)5-3-6;1-5(2,3)4/h2*2-5,8-9H,1H3;(H2,1,2,3,4)- Substance type: Organic- Physical state: Solid crystalline (off white - white- Batch: F1058599- Purity: 99.8%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
sex: male

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: 0.5% aqueous Carboxymethylcellulose
Controls:
yes
Amount / concentration applied:
0.5 ml of 3% N-methyl p-aminophenol sulphate in 0.5% aqueous Carboxymethylcellulose
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the dressing
Number of animals:
3 male rabbits
Details on study design:
TEST SITE- Area of exposure: left flank (3 minutes), the anterior right flank (1 hour) and the posterior right flank (4 hours) of one animal- Type of wrap if used: semi-occlusive dressing and a restraining bandage.

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No cutaneous reactions were observed

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
No cutaneous reactions were observed after 72 hours in the rabbits. Hence, N-methyl-p-aminophenol sulphate can be considered not irritating to rabbit skin.
Executive summary:

The dermal irritation potential of N-methyl-p-aminophenol sulphate was assessed in rabbits.The study was performed as per OECD 404 Guidelines. Doses of 0.5 ml of N-methyl-p-aminophenol sulphate at a concentration of 3% were placed on gauze pads and successively applied to a clipped area on the left flank (3 minutes), the anterior right flank (1 hour) and the posterior right flank (4 hours) of one New Zealand White male rabbit. Untreated skin served as a control. Because the dosage form was not irritating in the first animal, it was applied for 4 hours to the two additional animals. The treated sites were observed for signs of irritation at1, 24, 48 and 72 hours after removal of the dressing.

No cutaneous reactions were observed after 72 hours in the rabbits.

Hence,N-methyl-p-aminophenol sulphate can be considered not irritating to rabbit skin.