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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from SCCP, 2006

Data source

Reference
Reference Type:
secondary source
Title:
Opinion on p-Methylaminophenol Sulphate
Author:
European Commission
Year:
2006
Bibliographic source:
Scientific Committee On Consumer Products, SCCP/0963/05, 2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
A rat bone marrow micronucleus assay was performed to determine the mutagenic nature of N-Methyl-p-aminophenol sulfate.
GLP compliance:
yes
Type of assay:
other: Rat bone marrow micronucleus assay

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: N-Methyl-p-aminophenol sulfate- IUPAC name: 4-(Methylamino)phenol Sulfate - Molecular formula: C7H9NO.1/2H2O4S- Molecular weight: 344.386 g/mol- Substance type: Organic- Physical state: No data - Purity: 98.7%- Impurities (identity and concentrations): 1.3%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
No data available
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
No data available
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with the suitable vehicle at dose levels of 0, 100, 200 or 400 mg/kg bwDIET PREPARATION- Rate of preparation of diet (frequency): No data available- Mixing appropriate amounts with (Type of food): No data available- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): Water- Concentration in vehicle: 0, 100, 200 or 400 mg/kg bw- Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
Duration of treatment / exposure:
24 and 48 (highest dose group only) hours after the treatment
Frequency of treatment:
Once
Post exposure period:
No data available
Doses / concentrations
Remarks:
Doses/Concentrations: 0, 100, 200 or 400 mg/kg bw
No. of animals per sex per dose:
Total: 50 ratsControl: 5 males, 5 femalesPositive control: 5 males, 5 females100 mg/kg bw: 5 males, 5 females200 mg/kg bw: 5 males, 5 females400 mg/kg bw: 5 males, 5 females
Control animals:
yes, concurrent vehicle
Positive control(s):
Yes, in accordance with the OECD guideline

Examinations

Tissues and cell types examined:
Micronuclei isolated from bone marrow
Details of tissue and slide preparation:
No data available
Evaluation criteria:
The test chemical was considered positive only if a significant increase in the MNPCE frequency was noted.
Statistics:
No data available

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
yes
Positive controls valid:
yes
Additional information on results:
There was no indication of bone marrow toxicity in the micronucleus test because the PCE/NCE ratio was not lower in all treated groups than in the negative control group.

Applicant's summary and conclusion

Conclusions:
p-Methylaminophenol sulphate did not induce chromosome aberrations or damage to the mitotic apparatus in bone marrow cells of rats after oral treatment and hence it is not likely to classify as a gene mutant in vivo.
Executive summary:

A rat bone marrow micronucleus assay was performed to determine the mutagenic nature of p-Methylaminophenol sulfate in male and female Sprague-Dawley rats. On the basis of a preliminary toxicity study conducted, the doses for the main study was 0, 100, 200 or 400 mg/kg bw, and concurrent negative and positive controls were included in the study. The highest dosed group animals were sacrificed after 24 and 48 hrs after the treatment. The results showed no indication of bone marrow toxicity in the micronucleus test because the PCE/NCE ratio was not lower in all treated groups than in the negative control group. However, oral bioavailability can be assumed by the systemic clinical signs and the death of one animal treated with 400 mg/kg. The mean MNPCE frequencies were not significantly increased in any of the groups treated with the test substance. In addition, p-Methylaminophenol sulphate did not induce chromosome aberrations or damage to the mitotic apparatus in bone marrow cells of rats after oral treatment. Therefore, since no mutagenic effects could be observed, it is not likely to classify as a gene mutant in vivo.