Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
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 dermal toxicity study
GLP compliance:
no
Test type:
other: acute dermal 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:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
1260, 2000, 3160, 5010, 7940 mg/kg bw
No. of animals per sex per dose:
1 per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Based on:
test mat.
Remarks on result:
other: death occured at 5010 mg/kg bw and higher, clinical signs like reduced appetite and activity (survivors), increased weakness, collapse and death (2 to 3 days) occured after application

Any other information on results incl. tables

Mortality

1260 mg/kg: male -, female (0/1), combinded (0/1)

2000 mg/kg: male (0/1), female -, combinded (0/1)

3160 mg/kg: male -, female (0/1), combinded (0/1)

5010 mg/kg: male (1/1), female -, combinded (1/1)

7940 mg/kg: male -, female (1/1), combinded (1/1)

Time of mortality: 2 to 3 days after test substance application

Clinical signs:

Reduced appetite and activity (three to seven days in survivors), increasing weakness, collapse, and death

Gross autopsy findings:

Decedents: lung hyperemia, liver discoloration, enlarged gall bladder, and gastrointestinal inflammation

Survivors (14 days): animal # 1: viscera appeared normal, animals #2 and #3: slight discoloration of liver and kidneys

Applicant's summary and conclusion