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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study; original reference in Japanese, compilation of data from English summary and tables

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
EC Number:
212-344-0
EC Name:
N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
Cas Number:
793-24-8
Molecular formula:
C18H24N2
IUPAC Name:
N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine
Details on test material:
IUCLID4 Test substance: other TS: purity 99 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
0, 250, 500, 1000, 2000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 005 mg/kg bw
95% CL:
711 - 1 604
Remarks on result:
other: clinical signs, pathological lesions in digestive organs and respiratory
Sex:
female
Dose descriptor:
LD50
Effect level:
893 mg/kg bw
95% CL:
634 - 1 346
Remarks on result:
other: clinical signs, pathological lesions in digestive organs and respiratory

Any other information on results incl. tables

RS-Freetext:
LD50: 1005 mg/kg (95% confidence limit: 711-1604 mg/kg)

MORTALITY:
-Time of death: day 2-4 p.a.
-Number of deaths at each dose males : 0/5, 0/5, 0/5, 2/5, 5/5

-Number of deaths at each dose females: 0/5, 0/5, 0/5, 3/5, 5/5


CLINICAL SIGNS:
from 500 mg/kg males and females: reduced volume of feces; 
from 1000 mg/kg: hypoactivity, diarrhea, bradypnea,
hypothermia, prone position;
2000 mg/kg males: abnormal gait

2000 mg/kg: lacrimation, weakness of limbs

NECROPSY FINDINGS:
pathological lesions in digestive organs and respiratory
system

POTENTIAL TARGET ORGANS:
not reported

SEX-SPECIFIC DIFFERENCES:
male rats were less sensitive than female rats

Applicant's summary and conclusion