Propane-1-thiol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-01-06 to 1981-02-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

This study is classified as reliable with restrictions because it was conducted in accordance to GLP and was reviewed by Quality Assurance. There were no deviations from protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: UBTL test protocol NO. 02-50

Deviations:

no

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

Details on test material:

- Name of test material (as cited in study report): propane-1-thiol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: University of Utah vivarium
- Housing: housed individually in galvanized steel rabbit cage with screen floors and pans
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 to 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 New Zealand albino rabbits

Details on study design:

TEST SITE
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lightly sponged
-Test substance was removed after 24 hours
- Time after start of exposure: 7 days


SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 5

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 6

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 7

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 9

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 11

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 12

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Results 13

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

No score reported at 48 hours.

Irritant / corrosive response data:

Three of six animals treated with propane-1-thiol sample exhibited very slight erythema on both abraded and unabraded sites at 25 hours post dosing. The other 3 animals appeared normal. Animals were not scored for irritatation at 48 hours after dosing. At 72 hours post dosing, 1 animal had very slight erythema on the abraded site only. All other animals had either returned to normal or remained normal. On day 7, no erythema and/or oedema was observed in any animal.

Any other information on results incl. tables

Animal Number	627	628	646	614	615	616	Ave.	Range
Observation, prescreen	0	0	0	0	0	0	0	0
25 hour	1	0	0	0	1	1	0.5	0-1
72 hour	0	0	0	0	0.5	0	0.1	0-0.5
7 day	0	0	0	0	0	0	0	0
Combined 25 & 72 hour	0.5	0	0	0	0.8	0.5	0.3	0-0.8
Combined 25 & 72 hour and 7 day	0.3	0	0	0	0.5	0.3	0.2	0-0.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Propane-1-thiol was slightly irritating to 3 out of 6 rabbits. Results were scored at 25 and 72 hrs and 7 days post exposure using the Primary Skin Irritation Test. The mean Draize score of 0.2 was tabulated from the 6 rabbits at these 3 observation periods.

Executive summary:

In a primary dermal irritation study, intact and abraded skin of 6 young adult New Zealand albino rabbits was exposed to 0.5 mL of propane-1 -thiol for 24 hours to 1 square inch of abraded skin. Animals were then observed for 7 days. Irritation was scored by the method of Draize primary skin irritation test.

 

Propane-1-thiol was slightly irritating to 3 out of 6 rabbits; slight erythema was reported on both abraded and intact sites in 3 animals at 25 hours post dosing. The other 3 animals appeared normal. At 72 hours after dosing, 1 animal had slight erythema on the abraded site only. All other animals had either returned to normal or remained normal. On day 7, erythema and/or oedema was not observed in any animal. In this study, propane-1 -thiol is slightly irritating to the skin based on the Draize primary skin irritation test.

 

This study received a Klimisch score of 1 and is classified as reliable with restrictions because it was conducted in accordance to GLP and was reviewed by Quality Assurance. There were no deviations from protocol.