N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principle following a contemporary guideline, with incomplete reporting or methodological deficiencies. This reference does not provide a full report with regard to the methods used in this study. Some basic key information is reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: FHSA 1500.42

Deviations:

not specified

Principles of method if other than guideline:

The undiluted test material was applied to the eye of a single New Zealand White rabbit and the irritation evaluated after 24, 48 and 72 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

EC Number:

234-205-3

EC Name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Cas Number:

10595-60-5

Molecular formula:

C16H33N3

IUPAC Name:

N-(1,3-dimethylbutylidene)-N'-{2-[(1,3-dimethylbutylidene)amino]ethyl}ethane-1,2-diamine

Test material form:

other: watery liquid

Details on test material:

- Physical details: light amber, watery liquid with a highly noticeable odour.
- Storage conditions: ambient room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum Wayne diet
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single installation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1

Details on study design:

The undiluted test material was applied to the eye of a single New Zealand White rabbit and the irritation evaluated after 24, 48 and 72 hours.
The eye was stained with fluorescein at 24 hours to aid with scoring.

SCORING SYSTEM: Draize Scale for Ocular Irritation.

1. CONJUNCTIVAE

Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3

Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4

Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3

2. IRIS

Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2


3. CORNEA

Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4

Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

2

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: The area of corneal opacity was an average of 3.33 at 24, 48 and 72 hours

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

1

Max. score:

1

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

3

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

3.33

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

other: mean at 24, 48 and 72 hours

Score:

2.33

Max. score:

3

Reversibility:

not specified

Results 6

Irritation parameter:

overall irritation score

Remarks:

Draize scale

Basis:

animal #1

Time point:

other: mean at 24,48 and 72 hours

Score:

55.7

Max. score:

63

Reversibility:

not specified

Irritant / corrosive response data:

The test material caused injury to the cornea, iris and conjunctiva. Immediately upon installation, severe redness and chemosis of the conjunctiva as well as corneal opacity was noted.
Due to the severity of the response, no further animals were treated.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test material was seen to cause irritation to the eye.

Executive summary:

An eye irritation study was conducted broadly in accordance with the standardised guideline FHSA 1500.42.

0.1 mL of the undiluted test material was applied to the eye of a single New Zealand White rabbit and the irritation evaluated after 24, 48 and 72 hours using the Draize scale with total scores of 63, 53 and 51 respectively.

The test material caused injury to the cornea, iris and conjunctiva. Immediately upon installation, severe redness and chemosis of the conjunctiva as well as corneal opacity was noted.

As a result of severe reaction of the eye and conjunctiva, no further animals were dosed.

Under the conditions of this study, the test material was seen to cause irritation to the eye. However there is insufficient data to definitively classify the test material in accordance with EU criteria.