Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1965-03-04 to 1965-06-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions: no data on mortality / dose group and how LD50 was calculated, only male animals used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Principles of method if other than guideline:
other: comparable to guideline study with acceptable restrictions: no data on mortality / dose group and how LD50 was calculated, only male animalsused; see test conditions
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
EC Number:
247-063-2
EC Name:
2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine
Cas Number:
25513-64-8
Molecular formula:
C9H22N2
IUPAC Name:
2,2,4-trimethylhexane-1,6-diamine; 2,4,4-trimethylhexane-1,6-diamine
Test material form:
other: liquid
Details on test material:
Purity not reported; density 0.867 g/ml (20 °C).
Actually the test substance is identified in the reference with CAS No. 25620-58-0. However, the production process has been yielding the 2,2,4 (or 2,4,4) isomer mixture (CAS No. 25513-64-8) all the time since the beginning of the production of this substance at this site. In previous years the substance was not identified with a precision sufficient for REACH. The correct CAS No. would have been 25513-64-8 all the time.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: 
_ Number of animals: 5 per dose
- Weight at study initiation: 110-130 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
ADMINISTRATION: 
- Doses: 50 % v/v solution in water   (= 0.4335 g test substance/ml);   0.5, 1.0, 1.5, 2.0 and 2.5 ml per kg b.w.
- Route: oral gavage
Doses:
217; 434; 650; 867; 1080 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS: organs not listed

- Post dose observation period: 14 days
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
910 mg/kg bw
Mortality:
MORTALITY: LD50 = 2.1 ml solution/kg bw
- Time of death: After 12 to 18 hours in lateral position, no data on  mortality / dose group
Clinical signs:
other: CLINICAL SIGNS: 1 hour after dosing, animals showed restlessness, thirst,  rough fur and tiredness. 
Gross pathology:
NECROPSY FINDINGS: Irriation of the intestinal mucosa, with some rats showing a slight increase in kidney weight and / or protein in the urine.
Other findings:
POTENTIAL TARGET ORGANS: Kidney

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
According to this study the LD50 value (oral) was determined to be 910 mg/kg bw in rats. Therefore under the conditions of this study 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is harmful if swallowed.
Executive summary:

The test item 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine was applied once to 5 dose-groups of rats (5 male Wistar rats per dose-group) in doses of 217; 434; 650; 867; 1080 mg/kg bw as 50 % v/v solution in water. The animals were observed for mortality and any sub-lethal effects for 14 days after dosing.

Animals died within 12- 18 hours after oral application of the test item in lateral position. Clinical signs were irritation of the intestinal mucosa with some rats showed slight increase in kidney weight and protein in the urine. In all dose groups an increase in activity, rough fure, decrease of food consumption and lethargie was observed beginning 1 hour after dosing.

According to this study the LD50 value (oral) was determined to be 910 mg/kg bw in rats. Therefore under the conditions of this study 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is harmful if swallowed.