4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline

EC Number:

251-607-4

EC Name:

4-(tert-butyl)-N-sec-butyl-2,6-dinitroaniline

Cas Number:

33629-47-9

Molecular formula:

C14H21N3O4

IUPAC Name:

N-sec-butyl-4-tert-butyl-2,6-dinitroaniline

impurity 1

Reference substance name:

Xylene

EC Number:

215-535-7

EC Name:

Xylene

Cas Number:

1330-20-7

Molecular formula:

C8H10

IUPAC Name:

m-xylene

Test animals

Species:

dog

Strain:

Beagle

Sex:

male/female

Administration / exposure

Route of administration:

oral: capsule

Duration of treatment / exposure:

4 weeks

Frequency of treatment:

Twice a day

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

3 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

10 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

30 mg/kg bw/day (nominal)

Doses / concentrations 5

Dose / conc.:

80 mg/kg bw/day (nominal)

Doses / concentrations 6

Dose / conc.:

160 mg/kg bw/day (nominal)

Doses / concentrations 7

Dose / conc.:

240 mg/kg bw/day (nominal)

No. of animals per sex per dose:

1

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

When compared to controls, a slightly lower body weight gain was observed in aminels given 10 mg/kg/day and in the female given 160 mg/kg/day. Since these effects were not dose-related and due to restricetd number of animals, they were not attributed to treatment with the test item. In the male given 240 mg/kg/day, a slightly lower body weight gain was also noted, sinc it was correlated with lower food consumption observed throughout the study, this effect was considered to treatment-related.

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Description (incidence and severity):

Similar food consumption was noted in control and treated animals except in the male given 240 mg/kg/day which sowed a trend to a lower food consumption (generally 75% of the quantity given) ; this was associated with a lower body weight gain and could be considered to be treatment-related.

Haematological findings:

effects observed, non-treatment-related

Urinalysis findings:

no effects observed

Organ weight findings including organ / body weight ratios:

no effects observed

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

ca. 160 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

body weight and weight gain

Target system / organ toxicity

Key result

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

The twice daily administrationof th test item, Technical Butralin, at 1.5, 5, 15, 40, 80 or 120 mg/kg/administration (i.e. 3, 10, 30, 80, 160 or 240 mg/kg/day) to beagle dogs for 4 weeks was well tolerated up to 160 mg/kg/day.
At 240 mg/kg/day, it resulted in reduced body weight gain associated with a reduced food consumption in males.