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Diss Factsheets

Toxicological information

Eye irritation

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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:
other: This study was classified as reliable with restrictions because all tests conducted were in accordance with GLP and the test protocol followed is similar 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)
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 (Octane-1-thiol)
- Substance type: Heavy Mercaptan
- Physical state: Liquid

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
- Housing: Rabbits were housed individually in wire cages with stainless steel pans
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 day


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 milligrams or 0.1 mL

Duration of treatment / exposure:
exposure lasted 4 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 New Zealand white albino rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 seconds


SCORING SYSTEM: Draize et al. 1944


TOOL USED TO ASSESS SCORE: hand-held ophthalmoscope

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
ca. 0.4
Max. score:
110
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Octane-1-thiol demonstrated irritation in 3 out of 6 rabbits using the primary eye irritation test (unwashed). Clinical signs of irritation observed were slight redness at the 1 hour observation, with secreted discharge observed in one animal at day 4. All animals had recovered by day 7.
Other effects:
All animals were weighed on the day of arrival, the day of dosing and day 7. The combined mean weight gain from day of dosing to day 7 was approximately 254 grams.

Any other information on results incl. tables


 

Score

Number of Animals with Eye Response

 

 

 

 

 

 

 

Total

Animal Number

550

551

552

553

554

555

Ave.

Total

Observation, Prescreen

0

0

0

0

0

0

0

0

0

1 hour

2

2

0

0

2

0

1.0

0-2

3

24 hour

0

2

0

0

0

2

0.7

0-2

2

48 hour

0

2

0

0

0

0

0.3

0-2

1

72 hour

0

2

0

0

0

0

0.3

0-2

1

4 day

0

0

0

0

0

2

0.3

0-2

1

7 day

0

0

0

0

0

0

0

0

0

Combined Average

0.3

1.3

0

0

0.3

0.7

0.4

0-2

 

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 irritation in 4 out of 6 rabbits using the Primary Eye irritation test (unwashed). The mean Draize score of 0.4 was tabulated from the 6 rabbits including 6 observation periods.
Executive summary:

In a primary eye irritation study, 0.1 mL of octane-1-thiol was instilled into the conjunctival sac of the right eye of 6 young adult New Zealand white rabbits for 4 seconds while the untreated left eye served as control. Animals then were observed for 7 days. Irritation was scored by the method of the Draize Primary Eye Irritation Test (unwashed).

 

Octane-1-thiol demonstrated irritation in 4 out of 6 rabbits, with a mean Draize score of 0.4.  In this study, octane-1-thiol is slightly irritating to the eye because most of the effects observed were reversible in the first 24 hours post exposure, and all were reversible 7 days after exposure.

 

This study received a Klimisch score of 1 and was classified as reliable with restrictions because all tests conducted were in accordance with GLP and the test protocol followed is similar to OECD guideline 405.