Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Principles of method if other than guideline:
Preliminary LD50 for dose selection
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
2,2,4(or 2,4,4)-trimethylhexamethylenediamine
IUPAC Name:
2,2,4(or 2,4,4)-trimethylhexamethylenediamine
Test material form:
other: liquid
Details on test material:
2,2,4(or 2,4,4)-trimethylhexamethylenediamine of Hüls AG, purity not reported.

Test animals

Species:
hamster, Chinese
Strain:
other: Han-Chinese
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: 
- Age: 3 to 4 months
- Source: Zentralinstitut für Versuchskunde, Hanover (Germany)
- No. of animals per dose: 1 male + 1 female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
ADMINISTRATION: 
- Vehicle: water (aqua ad injectabilia); 10 ml/kg bw applied
- Post dose observation period: not reported
Doses:
30; 60; 125; 250 mg/kg bw
No. of animals per sex per dose:
1
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 125 mg/kg bw
Mortality:
MORTALITY:   
250 mg/kg bw: 2/2 animals died within 3 hours.   
125 mg/kg bw: The male died within 24 hours.
Clinical signs:
CLINICAL SIGNS:   
250 mg/kg bw: Severe apathia, sedation, hypothermia, loss of general  reactions, reduced righting reflexes, temporarily Writhing reflexes as a  
sign of abdominal pain reactions, irregular respiration (dyspnea).   
125 mg/kg bw: Similar signs but less severe, recovery of surviving  animal   
60 mg/kg bw: Slight apathia (transient)   
30 mg/kg bw: No signs

Applicant's summary and conclusion