2-[[3-(dimethylamino)propyl]methylamino]ethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 August 1980 (started); 30 September 1980 (reported)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study report provides basic data, but some details missing including duration of treatment, individual animal data and scoring system

Data source

Reference

Reference Type:

other: research report

Title:

Unnamed

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

In general the techniques of tests as published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71: 36, 1952) were followed.

GLP compliance:

no

Remarks:

study was conducted before implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

2-[[3-(dimethylamino)propyl]methylamino]ethanol

EC Number:

279-903-9

EC Name:

2-[[3-(dimethylamino)propyl]methylamino]ethanol

Cas Number:

82136-26-3

Molecular formula:

C8H20N2O

IUPAC Name:

2-{[3-(dimethylamino)propyl](methyl)amino}ethan-1-ol

Details on test material:

- Name of test compound: ABBOTT-51806
- Lot No. 7753-37

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

weight at study initiation: 2.82 kg (mean)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL/animal

Duration of treatment / exposure:

not specified

Observation period (in vivo):

30 days

Number of animals or in vitro replicates:

9 males, half of which had their eyes rinsed with water (20-30s) after treatment

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: corneal opacity

Basis:

mean

Reversibility:

other: washed eye: reversible within 30 days; unwashed eye: reversible within 22 days

Remarks on result:

other: moderate corneal opacity in all animals (no difference between unwashed and washed eye)

Results 2

Irritation parameter:

other: iritis

Basis:

mean

Reversibility:

other: washed eye: reversible within 30 days; unwashed eye: reversible within 22 days

Remarks on result:

other: slight to moderate iritis in all animals (no difference between unwashed and washed eye)

Results 3

Irritation parameter:

other: conjunctivitis

Basis:

mean

Reversibility:

other: washed eye: reversible within 7 days; unwashed eye: reversible within 8 days

Remarks on result:

other: moderate conjunctivitis in all animals (no difference between unwashed and washed eye)

Results 4

Irritation parameter:

other: chemosis

Basis:

mean

Reversibility:

not specified

Remarks on result:

other: moderate chemosis in all animals (no difference between unwashed and washed eye)

Results 5

Irritation parameter:

other: discharge

Basis:

mean

Reversibility:

not specified

Remarks on result:

other: discharge in all animals (no difference between unwashed and washed eye)

Irritant / corrosive response data:

scores (including the reversibility of the effects observed) for individual animals: not available

Applicant's summary and conclusion

Interpretation of results:

other: interpretation of results not possible (due to limited documentation), but also not necessary as the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Conclusions:

Signs of ocular irritation were observed after test substance administration, i.e.
- corneal opacity (reversible within 30 days for washed eye, within 22 days for unwashed eye),
- iritis (reversible within 30 days for washed eye, within 22 days for unwashed eye),
- conjunctival redness (reversible within 7 days for washed eye, within 8 days for unwashed eye),
- chemosis and
- discharge.

Executive summary:

The substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol was tested in a primary ocular irritation study comparable to OECD guideline 405 (prior to introduction of GLP).

Nine male New Zealand White rabbits were used; for 3 animals substance was washed out after 20-30 seconds, whereas for the remaining animals eyes were not washed.

Signs of ocular irritation were observed after test substance administration, i.e. corneal opacity (reversible within 30 days for washed eye, within 22 days for unwashed eye), iritis (reversible within 30 days for washed eye, within 22 days for unwashed eye), conjunctival redness (reversible within 7 days for washed eye, within 8 days for unwashed eye), chemosis and discharge.

In conclusion, undiluted 2-[[3-(dimethylamino)propyl]methylamino]ethanol caused severe irritation when instilled directly into the eyes of rabbits.

The presented experimental data would not be sufficient to classify the substance, but this is not necessary as the substance is classified as skin corrosive (sub-category 1B; H314); such a substance is automatically considered to be severely damaging to the eye and is classified but not labelled for serious eye damage in addition to skin corrosion.