4-nitro-m-xylene

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-05-05 to 1989-03 (revised 1991-11)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study according to OECD TG.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

no

Remarks:

however, deviations from the protocol occurred.

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-nitro-m-xylene

EC Number:

201-947-4

EC Name:

4-nitro-m-xylene

Cas Number:

89-87-2

Molecular formula:

C8H9NO2

IUPAC Name:

2,4-dimethyl-1-nitrobenzene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Continous dietary administration to rats for 28 days.

Frequency of treatment:

Continous treatment, feed was available ad libitum.

Doses / concentrations

Remarks:

Doses / Concentrations:
0 ppm, 100 ppm, 600 ppm, 3000 ppm
Basis:
nominal in diet

No. of animals per sex per dose:

5 male and 5 female rats per dose

Control animals:

yes, plain diet

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

600 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: - At this dose (mid-dose) none of the parameters determined in the course of this study showed changes that were considered to be of toxicological significande - 600 ppm corresponds to an actual substance intake of about 60 mg/kg body weight per day.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Changes observed were the following:

- slight growth retardation in the mid- and top-dose group, while the retardation in the mid-dose group was considered of no toxicological relevance, since it was only slight and not statistically significant

- increases in liver weight, accompanied by decreases in total protein and albumin content in plasma (top-dose)

- in males of the top-dose: decreases in red blood cell count and haemoglobin concentration, increased adrenals weight (top-dose)

- in females: increased spleen weight

Applicant's summary and conclusion

Conclusions:

It is concluded that the no-toxic effect level of 4-nitro-1,3-dimethylbenzol in the present study is 600 ppm in the diet. This level is equivalent to a nominal overall intake of about 60 mg/kg body weight per day.