2-Propanamine, compd. with boron trifluoride, reaction products with Bu glycidyl ether

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The Consumer Product Safety Commission of the U .S .A. , The Code of Federal Regulations, Title 16, Section 1500.42

Deviations:

yes

Remarks:

Due to the severity of the reactions only two animals were used

Principles of method if other than guideline:

TEST FOR EYE IRRITANTS
From: Code of Federal Regulations, Title 16, Section 1500.42
Six a lbino rabhitr a r e used for e a ch test substance. Artimal facilities for such procedures shall be so
designed and maintained as to exclude sawdust, wood chips, or other extraneous materials that might produce
eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those
animals without eye defects or irritation shall be used. The animal is held firmly but gently until quiet. The test
mateiial is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form
a cup into which the test substance is dropped. The lids are then gently held together for one second and the
animal is released. The other eye, remaining untreated, serves as a control. For testing liquids, 0.1 milliliter
is used. FOF solids OT pastes, 100 milligram of the test substance is used, except that for substances in flake,
granule, powder, or other particulate form the amount that has a volume of 0.1 milliliter (after compacting
as much as possible without crushing or altering the individual particles, such as by tapping the measuring
container) shall be used whenever this volume weighs less than 1 00 milligram. In Puch a case, the weight of the
0.1 milliliter test dose should be recorded. The eyes are not washed following instillation of test material except
as noted below.
The eyes are examined and the grade of ocular reaction is recorded a t 24, 48 and 72 hours. Reading of
reaction is facilitated by use of a binocular loupe, hand sl it-lamp, or other expert means. After the recording
of observations a t 24 hours, any or all eyes may be further examined after applying fluorescein. For this
optional test, one drop of fluorescein sodium ophthalmic solution U .S . P. or equivalent is dropped direct1 y
on the cornea. After flushing out the excess fluorescein with sodium chloride solution U .S . P. or equivalent,
injured areas of the cornea appear yellow; this is best v i s u l a i z d in a darkened room under ultra-violet
illumination. Any or all eyes may be washed with sodium chloride solution U .S.P. or equivalent after the 24
hour reading .
An animal shall be considered as exhibiting a positive reaction if the test substance produces a t any
of the readings ulceration of the cornea (other than a fine stippling), or opacity of the cornea (other than a
slight dulling of the normal lustre), or inflammation of the iris (other than a slight deepening of the folds
(or rugae) or a slight circumcorneol injection of the blod vessels), or if such substance produces in the
conjunctivae (excluding the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse
crimson-red with individual vessels not easily discernible.
The test shall be considered positive if four or more of the animals in the test group exhibit a positive
reaction. If only one animal exhibits a positive reaction, the test shall be regarded as negative. If two or
three animals exhibit a positive reaction, the test is repeated using a different group of six animals. The
second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or
two animals in the second test exhibit a positive reaction, the test shall be repeated with a different group of
six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits
a positive response.
To assist testing laboratories and other interested persons in interpreting the results obtained when a
substance is tested in accordance with the method described in paragraph 1 of this section , an "Illustrated
Guide for Grading Eye Irritation by Hazardous Substances" will be sold by the Superintendent of Documents,
Government Printing Off ice, Washington, D .C . The guide will contain colour plate depicting responses of
varying intensity to specific test solutions. The grade of response and the substance used to produce the response
will be indicated.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Propanamine, compd. with boron trifluoride, reaction products with Bu glycidyl ether

EC Number:

270-846-5

EC Name:

2-Propanamine, compd. with boron trifluoride, reaction products with Bu glycidyl ether

Cas Number:

68478-97-7

Molecular formula:

C10H23BF3NO2

IUPAC Name:

2-propanamine, compd. with boron trifluoride, reaction products with butyl glycidyl

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml of pure material to one eye

Duration of treatment / exposure:

Single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2 animals

Details on study design:

See section - Principles of method...

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

3

Max. score:

4

Reversibility:

not specified

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not specified

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

1

Max. score:

2

Reversibility:

not specified

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not specified

Results 12

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

1

Max. score:

2

Reversibility:

not specified

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not specified

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

3

Reversibility:

not specified

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not specified

Results 16

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not specified

Results 17

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 18

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 19

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not specified

Results 20

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not specified

Results 21

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Due to the severity of the reactions two animals only were used. Both animals were sacrificed on day 7.
Corneal opacities developed in both animals. Severe vacuolation of the cornea was seen in one animaI.
Vascularization was observed in the other animaI. lritis was observed in both animals, and in one this effect was severe.
A diffuse crimson red colouration of the conjunctivae and considereable swelling with the eye lids about haIf closed was observed in both animaIs.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl ether was tested for eye irritation using in vivo method with rabbits described in The Consumer Product Safety Commission of the U.S.A., The Code of Federal Regulations, Title 16, Section 1500.42. Test material was found to be irritating to eyes.

Executive summary:

Boron (2-propanamine) trifluoro-, rxn prod with butyl glycidyl ether was tested for eye irritation using in vivo method with rabbits described in The Consumer Product Safety Commission of the U.S.A., The Code of Federal Regulations, Title 16, Section 1500.42. Test material was found to be irritating to eyes.