Bis(4-hydroxy-N-methylanilinium) sulphate

Skin irritation / corrosion

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

Reference

Reference 1

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 2

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 3

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

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

Test material information

Constituent 1

Reference substance name:

Bis(4-hydroxy-N-methylanilinium) sulphate

EC Number:

200-237-1

EC Name:

Bis(4-hydroxy-N-methylanilinium) sulphate

Cas Number:

55-55-0

Molecular formula:

C14H20N2O6S

IUPAC Name:

bis(4-hydroxy-N-methylanilinium) sulfate

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 or test system 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.