1-aminopropan-2-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06. Oct 1965 - 14. Oct 1965

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:

1965

Report date:

1965

Materials and methods

Principles of method if other than guideline:

BASF-Test: 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The report describes findings after 1 and 24 hours and at the end of the observation period. For final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-aminopropan-2-ol

EC Number:

201-162-7

EC Name:

1-aminopropan-2-ol

Cas Number:

78-96-6

Molecular formula:

C3H9NO

IUPAC Name:

1-aminopropan-2-ol

Specific details on test material used for the study:

- Analytical purity: 98 %

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline control.

Amount / concentration applied:

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

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal 1-2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal 1-2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 72 h reading is missing

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal 1-2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: 72 h reading is missing

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: 72 h reading is missing

Irritant / corrosive response data:

The detailed findings of the study are given in table 1 as converted gradings from BASF internal into OECD Draize system gradings.

Any other information on results incl. tables

Table 1: Findings of two animals: animal 1/animal 2

Time

Opacity

Iritis

Erythema

Chemosis

1 h

2/2

0/0

1/1

0/0

24 h

3/3

2/0

3/3

0/0

48 h

3/3

2/0

3/3

0/0

72 h

-/-

-/-

-/-

-/-

8 d

3/3

2/0

3/3

0/0

The original readings at 72 h are missing. The original BASF grading was converted into the numerical grading according the OECD Draize system.

Mean values over 24 h and 48 h; The 72 h reading is missing:

Animal1: Opacity: 3; Iritis: 2; Erythema: 3;

Animal2: Opacity: 3; Iritis: 0; Erythema: 3;

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The application of the test substance caused corrosion to the exposed eyes predominantly expressed by severe corneal opacity, severe erythema and iritis. After 48 h crusty eyelids, suppuration and staphyloma were noted. Severe corneal opacity and staphyloma are considered to be irreversible effects to ophthalmic tissue.