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Toxicological information

Eye irritation

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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

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 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

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)

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.