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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-01-12 to 1982-01-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was classified as reliable with restrictions because it was conducted in accordance to GLP, was reviewed by Quality Assurance and followed a protocol similar to OECD guideline 404.

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Animals were tested under occlusive conditions and exposure period was 24 hours
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Octane-1-thiol (CAS # 111-88-6)
IUPAC Name:
Octane-1-thiol (CAS # 111-88-6)
Details on test material:
- Name of test material (as cited in study report): n-Octyl Mercaptan
- Substance type: Heavy Mercaptan
- Physical state: Liquid

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

IN-LIFE DATES: From: 1981-01-06 To: 1981-01-19

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
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 secured with non adhesive tape and covered with plastic tube


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lightly sponged
- Time after start of exposure: 7 days


SCORING SYSTEM: Draize technique

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
Draize score
Basis:
mean
Time point:
other: 25 and 72 hours
Score:
ca. 0.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The Phillips octane-1-thiol sample elicited very slight erythema on both abraded and unabraded sites in 2 animals at 25 hours post dosing. One animal had slight erythema on the abraded site only. The other 3 animals appeared normal. At 72 hours post dosing, 2 animals had very slight erythema on both the abraded and unabraded sites. All other animals had either returned to normal or remained normal. On day 7, erythema and/or edema was not observed on any animal all appeared animals, except for one animal (#612) which had a very slight induration.

Any other information on results incl. tables

Animal Number

624

647

626

611

612

613

Ave.

Range

Observation, prescreen

0

0

0

0

0

0

0

0

25 hour

0

1.0

0.5

1.0

0

0

0.4

0-1

72 hour

0

0

1.0

2.0

0

0

0.5

0-2

7 day

0

0

0

0

0

0

0

0

Combined 25 & 72 hour

0

0.5

0.8

1.5

0

0

0.5

0-1.5

Combined 25 & 72 hour and 7 day

0

0.3

0.5

1.0

0

0

0.3

0-1.0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information (Not classified) Criteria used for interpretation of results: EU
Conclusions:
Octane-1-thiol demonstrated a slight irritance in 3 out of 6 rabbits using the Primary Skin Irritation Test. The mean Draize score of 0.3 (7 days) was tabulated from the 6 rabbits at 3 observation periods.
Executive summary:

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

 

The Phillips octane-1-thiol sample elicited very slight erythema on both abraded and unabraded sites in 2 animals at 25 hours past dosing. One animal had slight erythema on the abraded site only. The other 3 animals appeared normal. At 72 hours past dosing, 2 animals had very slight erythema on both the abraded and unabraded sites. All other animals had either returned to normal or remained normal. On day 7, erythema and/or edema was not observed on any animal all appeared animals, except for animal 612 which had a very slight induration. In this study, octane-1 -thiol is slightly irritating to the skin based on the Draize primary skin irritation test.

This study was classified as reliable with restrictions because it was conducted in accordance to GLP, was reviewed by Quality Assurance and followed a protocol similar to OECD guideline 404.