Butylamine

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:

1958

Report date:

1958

Materials and methods

Principles of method if other than guideline:

BASF-Test, see details in remarks on material and methods.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butylamine

EC Number:

203-699-2

EC Name:

Butylamine

Cas Number:

109-73-9

Molecular formula:

C4H11N

IUPAC Name:

butan-1-amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Butylamin

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the adjacent eye served as control treated with 0.9 % NaCl (saline).

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 50 µl

Duration of treatment / exposure:

single application

Observation period (in vivo):

5 weeks

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: effects not evaluable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effects

Any other information on results incl. tables

Findings: animal1/animal2

Time	Corneal opacity	Iritis	Erythema	Chemosis
1 h	3/3	-/-	0/0	1/1
24 h	3/3	-/-	0/0	1/1
48 h	3/3	-/-	0/0	1/1
72 h	3/3	-/-	0/0	1/1
8 days	3/x	-/x	0/x	-/x

x: animal 2 was sacrificied after 5 days due to paraplegia.

-: due to corneal opacity not evaluable

The original BASF grading was converted into the numerical grading according the OECD Draize system.

Mean values over 24 h, 48 h and 72 h:.

Animal1: Opacity: 3; Iritis: -; Erythema: 0; Chemosis: 1;

Animal2: Opacity: 3; Iritis: -; Erythema: 0; Chemosis: 1;

The application of the test substance caused after 10 minutes slight chemosis, necrosis and corneal opacity. Therefor a precise evaluation of erythema and iritis scores was not possible. The effects were not reversible within 5 weeks (animal1). Severe corneal opacity is considered to be an irreversible effect to ophthalmic tissue.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test substance induced irreversible effects on the eye.

Executive summary:

An eye irritation test was performed in two Vienna White rabbits. 50 μl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The eyes were not washed out after 24 hours. The animals were observed after 10 min, 1 h and 3 h on the day of treatment and up to 5 weeks afterwards. The application of the test substance caused after 10 minutes slight chemosis, necrosis and corneal opacity. Therefor a precise evaluation of erythema and iritis scores was not possible. The effects were not reversible within 5 weeks in animal 1.

The mean scores of eye irritation (24, 48 and 72 h) were for both animals: Opacity: 3; Iritis: not possible to examine; Erythema: 0; Chemosis: 1. The test substance induced irreversible effects on the eye.