Propane-1-thiol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980-12-19 to 1981-01-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study is classified as reliable with restrictions because it complies with GLP and adheres to OECD guideline 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

Method: other: UBTL Protocol No. 01A-50
Similar to OECD 405 and OPPTS 870.2400

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1-thiol

EC Number:

203-455-5

EC Name:

Propane-1-thiol

Cas Number:

107-03-9

Molecular formula:

C3H8S

IUPAC Name:

propane-1-thiol

Constituent 2

Reference substance name:

1-PROPANE-1-THIOL

IUPAC Name:

1-PROPANE-1-THIOL

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: University of Utah vivarium or other reputable breeder
- Housing: housed individually in wire cages with no sawdust or other dust producing material in the room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 +/- 3
- Humidity (%): 30 to 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hr / 12 hr

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

4 seconds

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-held ophthalmoscope adn then with fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

Draize system

Basis:

mean

Time point:

other: 1 hr.

Score:

8.3

Max. score:

14

Reversibility:

fully reversible

Results 2

Irritation parameter:

overall irritation score

Remarks:

Mean Draize score

Basis:

mean

Time point:

other: 24 hrs.

Score:

2

Max. score:

6

Reversibility:

fully reversible

Results 3

Irritation parameter:

overall irritation score

Remarks:

Mean Draize score

Basis:

mean

Time point:

other: 48 hrs., 72 hrs.

Score:

4.3

Max. score:

24

Reversibility:

fully reversible

Results 4

Irritation parameter:

overall irritation score

Remarks:

Mean Draize score

Basis:

mean

Time point:

other: 7 day

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period. Therefore, it can be concluded that the test substance is Cat 2 eye irritant. Average maximum score 6 per endpoint.

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 11

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 12

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 13

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 14

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4.5

Max. score:

6

Reversibility:

fully reversible within:

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 15

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 16

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 22

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 23

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 24

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 25

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 26

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

4.5

Max. score:

6

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 27

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Results 28

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

6

Remarks on result:

no indication of irritation

Remarks:

Only total eye irritation scores were reported for individual animals from observations at 24/48/72 hours. Eye irritation was observed in 3 out of 6 animals. All eyes appeared normal by day 7 of the observation period.

Any other information on results incl. tables

The star (*) indicates the observation of a lesion

Summary of Individual Scores

	Score								Number of Animals with Eye Response
	Unwashed						Total
Animal Number	562	563	564	569	570	590	Ave.	Range
Observation, Prescreen	0	0	0	0	0	0	0	0	0
1 hour	4	4	14	10*	6	12*	8.3	4-12	6
24 hour	0	2	4	6*	0	0	2.0	0-6	3
48 hour	0	2	0	24*	0	0	4.3	0-24	2
72 hour	0	2	0	24*	0	0	4.3	0-24	2
4 day	0	2	0	2*	0	0	0.7	0-2	2
7 day	0	0	0	0	0	0	0	0	0
Combined average	0.7	2.0	3.0	11.0	1.0	2.0	3.3	0.7-11

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, propane-1-thiol is an eye irritant in 3 out of 6 animals. All effects were fully reversible by day 7.

Executive summary:

In a primary eye irritation study, 0.1 millilitres of propane-1-thiol was placed on the everted lower lid of the right eye of six New Zealand white albino rabbits for seconds and then released.  The left eye remained untreated and served as a control. Eyes were not washed after exposure. Animals were observed for 7 days post dosing.  Irritation was scored by the method of Draize.

 

Ocular irritation was observed in all of the test animals following exposure (mean irritation score = 8.3, 2.0, 4.3, and 4.3 for 1, 24, 48, and 72 hours respectively). All signs of irritation dissipated at the end of the 7 day observation period.  The combined weight gain from day of dosing to day 7 was approximately 83 grams. In this study, propane-1-thiol is considered irritating to the eye based on the Draize method.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it complies with GLP and adheres closely to OECD guideline 405.