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Toxicological information

Repeated dose toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent

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.