3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

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:

BASF test: only 8 das observation period; eyes were not washed out after 24 h

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

EC Number:

230-745-9

EC Name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Cas Number:

7300-34-7

Molecular formula:

C10H24N2O2

IUPAC Name:

3-[4-(3-aminopropoxy)butoxy]propan-1-amine

Specific details on test material used for the study:

- Name of test material (as cited in study report): Butandiol-di(aminopropyl)-ether
- Physical state: liquid

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50 µl of the test item were applied to the right eye; the left eye serves as control and was treated with 50 µl NaCl; the test substance was not washed out after 24 h

Duration of treatment / exposure:

The test item was not washed out and remained in the eye for the entire course of the experiment

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: cannot be determined at day 8 due to severe corrosion

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Max. score:

3

Remarks on result:

other: strong erytheme at day 8

Irritant / corrosive response data:

Test item application had severe effects on rabbit eyes; after 8 days, severe pus formation can be observed accompanied by staphylom and scar formation, severe erythema and marked chemosis. Pus formation was observed during the entire course of the experiment; soft necosis was observed 24 and 48 and hard necrosis 72 h following test item application; due to the severe lesions, redness of the conjunctivae could not be assessed.

Any other information on results incl. tables

Irritation scores:

Time	Cornea		Conjuctivae		Iris		Chemosis
	A1	A2	A1	A2	A1	A2	A1	A2
24 h	3	3	n.a.	n.a.			2	3-4
48 h	3	3	n.a.	n.a.	2		3-4	3-4
72 h	3	3	n.a.	n.a.	2		2	3-4
8 d			2	2	2		2	2

A1/A2: Animal 1/Animal 2

n.a.: not assessable

No data concerning iritis for animal 2

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria