Bis(4-hydroxy-N-methylanilinium) sulphate

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

To assess the eye 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)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

sex: male

Test system

Vehicle:

other: 0.5% aqueous Carboxymethylcellulose

Controls:

yes

Amount / concentration applied:

0.1 ml of 3% N-methyl p-aminophenol sulphate in 0.5% aqueous Carboxymethylcellulose

Duration of treatment / exposure:

single exposure, The upper and lower lids were held closed for about 1 second to avoid any loss of test substance.

Observation period (in vivo):

1 hour after compound administration, and 24, 48 and 72 hours thereafter.

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

TEST SITE- Area of exposure: conjunctival sac of the left eye of the animals.REMOVAL OF TEST SUBSTANCE- Washing (if done): not washed

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:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

Very slight chemosis and redness of the conjunctiva were noted in 1/3 animals 1 hour after ocular instillation only. No other signs of ocular irritation were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Very slight chemosis and redness of the conjunctiva were noted in 1/3 animals 1 hour after ocular instillation only. No other signs of ocular irritation were observed during the study.Since the effects observed were reversible by 72 hours, n-methyl-p-aminophenol sulphate can be considered not irritating to eyes.

Executive summary:

The ocular irritation potential of N-methyl-p-aminophenol sulphate was assessed in rabbits.

The study was performed as per OECD 405 Guidelines. 0.1 ml of 3% N-methyl p-aminophenol sulphate in 0.5% aqueous Carboxymethylcellulose was instilled in the left eye of 3 male New Zealand White rabbits.The upper and lower lids were held closed for about 1 second to avoid any loss of test substance.The untreated right eye of each animal served as a control. The treated eyes remained unwashed throughout the study. The rabbits were observed for signs of irritation1 hour after compound administration, and 24, 48 and 72 hours thereafter.

Very slight chemosis and redness of the conjunctiva were noted in 1/3 animals 1 hour after ocular instillation only. No other signs of ocular irritation were observed during the study.

Since the effects observed were reversible by 72 hours, n-methyl-p-aminophenol sulphate can be considered not irritating to eyes.