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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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