2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine

Endpoint summary

Description of key information

2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is of moderate oral acute toxicity with an oral LD50(rat) of 910 mg/kg bw ( Klimmer, 1965). According 
to REACH Annex VIII, 8.5. column 2, acute dermal and inhalative toxicity studies do not need to be conducted if the substance is classified 
as corrosive to the skin.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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

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

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

no further remarks

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. 

Endpoint conclusion

Dose descriptor:

LD50

Value:

910 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 LD₅₀value (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.

Justification for classification or non-classification

According to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamin is classified as acute Tox. 4 (oral); H302: harmful if swallowed .