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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-11-24 to 1983-11-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
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:
2,2,4(or 2,4,4)-trimethylhexamethylenediamine of Hüls AG, purity 99.41 %; main impurity 1-amino-2-aminomethyl-3,3,5(or 3,5,5)-trimethylcyclopentane (0.29 %)

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 kg
- Number of animals: 1
- Diet: ad libitum Ssniff K4
- Water: ad libitum, tab water
- Controls: untreated eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 % +/-5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animal, untreated right eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml


Duration of treatment / exposure:
not rinsed; no removal of test substance
Observation period (in vivo):
1 , 24 hours
- Postexposure observation period: 24 hours
Number of animals or in vitro replicates:
1
Details on study design:
Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1 and 24 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet

Results and discussion

In vivo

Results
Irritation parameter:
other:
Basis:
animal #1
Time point:
other: 1 and 24 hours
Reversibility:
not reversible
Remarks on result:
other: The undiluted substance produced serious injury immediately (corrosive  effects, opalescence). 24 hours after treatment conjunctiva showed necrosis and test was interrupted.
Irritant / corrosive response data:
The undiluted substance produced serious injury immediately (corrosive  effects, opalescence). 24 hours after treatment conjunctiva showed  
necrosis and test was interrupted.
Other effects:
No other effects.

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test item 2,2,4(or 2,4,4) -trimethylhexane -1,6- diamine is considered to be corrosive to eyes of rabbits.
Executive summary:

The acute eye irritation properties of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine were estimated in a Draize test according to OECD TG 405. An amount of 0.1 ml of the undiluted test substance was instilled into the left eye of one male albino rabbit, and the untreated right eye served as control. The eye remained unrinsed and there was no removal of test substance. The undiluted substance produced serious injury immediately (corrosive  effects, opalescence). 24 hours after treatment conjunctiva 

showed necrosis and the test was interrupted. Therefore, under the conditions of this test 2,2,4(or 2,4,4) -trimethyl hexane -1,6-

diamine is considered to be corrosive to eyes.