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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
other: acute oral toxicity study
GLP compliance:
no
Test type:
other: acute oral toxicity study

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
EC Number:
221-375-9
EC Name:
N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
Cas Number:
3081-14-9
Molecular formula:
C20H36N2
IUPAC Name:
N1,N4-bis(5-methylhexan-2-yl)benzene-1,4-diamine
Details on test material:
Santoflex 77 (purity: 96%)

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
501, 631, 794, 1000 mg/kg bw
No. of animals per sex per dose:
5 (combined males and females)
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
730 mg/kg bw
Based on:
test mat.
95% CL:
690 - 770
Remarks on result:
other: Signs of intoxication: reduced appetite and activity (four to six days in survivors), increasing weakness, collapse, and death; gross autopsy (decedents): hemorrhagic areas of the lungs, liver discoloration and acute gastrointestinal inflammation

Any other information on results incl. tables

Mortality

501 mg/kg: male (1/2), female (0/3), combinded (1/5)

631 mg/kg: male (1/3), female (0/2), combinded (1/5)

794 mg/kg: male (1/2), female (2/3), combinded (3/5)

1000 mg/kg: male (3/3, female (2/2), combinded (5/5)

Time of mortality: Two to seven days after test substance application, most deaths occured in four days

Clinical signs:

Reduced appetite and activity (four to six days in survivors), increasing weakness, collapse, and death

Gross autopsy

Decedents: hemorrhagic areas of the lungs, liver discoloration and acute gastrointestinal inflammation

Survivors (10 day): viscera appeared normal

Applicant's summary and conclusion

Executive summary:

LD50 rat: 730 mg/kg bw