N-methylaniline

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

the study will be available on 2011/08/01

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: 3b. significant methodological deficiences concerning the endpoint to be examined.

Justification for data waiving:

other:

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

The toxic properties of xylidine and monomethylaniline

Author:

Treon JF, Deichmann WB, Sigmon HB, Wright H, Witherup SO, Heyroth FF, Kitzmiller KV, Keenan C

Year:

1949

Bibliographic source:

Journal of industrial hygiene and toxicology, vol 31, number 1

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The toxicity of monomethylaniline was determined by repeated application of this substance dermally to rabbits. The dosages were applied on abdominal skin of rabbits for one hour on each of five days per week during periods of more than 21 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-methylaniline

EC Number:

202-870-9

EC Name:

N-methylaniline

Cas Number:

100-61-8

Molecular formula:

C7H9N

IUPAC Name:

N-methylaniline

Test animals

Species:

rabbit

Strain:

not specified

Sex:

not specified

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

1 hour on 20 square inches shorn skin

Frequency of treatment:

Daily, 5 days per week, more than 21 days up to 50 days or until death occurred earlier.

Doses / concentrations

Remarks:

Doses / Concentrations:
0.10, 0.16, 0.22, 0.38, 0.39 and 0.72 g/kg
Basis:
nominal per unit body weight

No. of animals per sex per dose:

1 or 2

Results and discussion

Effect levels

Dose descriptor:

dose level: dosage not inducing observed effects after repeated exposure for 50 days.

Effect level:

100 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No mortality or loss of body weight of three rabbits exposed to 0.10 or 0.16 g/kg for 50 days.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Table 1: Mortality of rabbits associated with the repeated dermal administration of monomethylaniline.

Concentration	Duration	Number	Number	Weight
g/kg	days	exposed	dead	loss
0.10	50	2	0	no
0.16	50	1	0	no
0.22	22	1	1	?
0.38	12	1	1	?
0.39	22	1	0	18%
0.72	27	1	0	18%

Applicant's summary and conclusion

Conclusions:

N-methylaniline proved to readily penetrate the intact skin of rabbits. Although the results are not consistent, repeated dermal administration above 100 mg/kg appear to have a toxic effect on rabbits. However, dermal exposure appears to ask for higher dosages to induce similar signs of toxicity than oral administration or exposure by inhalation.