Propan-1-ol

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:

comparable to guideline study with acceptable restrictions

Remarks:

(prior to GLP, only two animals, application volume 0.05 ml)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(only two animals, application volume 0.05 ml)

Principles of method if other than guideline:

Eye irritation was tested using an internal method (BASF test). The liquid test substance were applied to the conjunctival sac of the right eye of each of the animals. The adjacent eye treated with a control substance served as the control. Eyes were not washed after application of the test substance. Documentation and scoring of changes to the eyes were performed at the different times.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propan-1-ol

EC Number:

200-746-9

EC Name:

Propan-1-ol

Cas Number:

71-23-8

Molecular formula:

C3H8O

IUPAC Name:

propan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

Analytical purity: 99.5%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Weight at test initiation: 3.25 kg and 2.42 kg
- Sex: females

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye was treated with saline solution

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume): 50 µl
- Concentration (if solution): undiluted (100%)

Duration of treatment / exposure:

Following application, the eyes were not washed.

Observation period (in vivo):

10 d

Number of animals or in vitro replicates:

2

Details on study design:

SCORING
- Scoring system: The findings were originally scored according to a BASF internal numerical system. The scores were then converted to Draize scores
- Time schedule: Examination and scoring were performed after 10min, 1h, 3h, 24h, 48h, 72h, 6d, 7d and 10d after instillation of the eye with the test substance

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24, 48, 72h

Score:

1.7

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: At the end of the observation period (10d), cloudy to milky opacity was still present in the eyes of both animals with Draize scores attaining 2 and 3, respectively. Staphylom was also present in 1/2 animals at conclusion

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24, 48, 72h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 10d

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24, 48, 72h

Score:

1.5

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: After 10 days, slight redness was still present in the eye of one animal while a well defined redness was present in the eye of the other animal

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24, 48, 72h

Score:

1.5

Max. score:

4

Reversibility:

not reversible

Remarks:

in one animal within 10 days

Remarks on result:

other: A well defined swelling was still present in only one animal at termination

Any other information on results incl. tables

Table 1: Summary of Results

Readings (time after instillation)	Animal	Cornea Opacity	Iris	Conjunctiva Redness	Swelling	Further findings
10 min	1	1	0	1	1	smeary discharge
	2	1	0	1	1	-
1h	1	1	0	1	2	smeary discharge
	2	1	0	1	2	smeary discharge
3h	1	1	0	1	2	smeary discharge
	2	2	0	1	2	smeary discharge
24h	1	1	2	1	2	purulence
	2	1	0	1	2	scar, nictitating membrane partly grey
48h	1	2	2	1	2	purulence, smeary discharge, scar
	2	2	0	2	1	scar, smeary discharge
72h	1	2	1	2	1	scar, nictitating membrane partly white
	2	2	1	2	1	scar, greyish nictitating and partly grey mucous membranes, purulence
6d	1	3	0	1	1	smeary discharge
	2	3	2	2	1	crusty eye surroundings, greyish nictitating membrane, purulence
7d	1	2	0	2	1	smeary discharge, nictitating membrane partly white
	2	3	0	2	2	sacr, purulence, nictitating membrane partly white, eyelid borders partly necrotic
10d	1	2	0	1	0	smeary discharge, ingrowth of vessels
	2	3	0	2	2	scar, letheary folds over the cornea (staphylom)
Mean (24h-72h)	1	1.7	1.7	1.3	1.7
	2	1.7	0.3	1.7	1.3
Mean (24h-72h)	all animals	1.7	1.0	1.5	1.5

At the end of the observation period (10d), staphylom was present in the eye of one animal. Cornea opacity was still well defined in the eyes of both rabbits at termination (Draize scores of 2 and 3, respectively). The severity of corneal opacity increased in one animal towards the end of the observation. Redness was still manifesting in the eyes of both animals (Draize scores of 1 and 2, respectively).

Applicant's summary and conclusion

Interpretation of results:

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