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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:
Sep/Oct 1981
Reliability:
2 (reliable with restrictions)

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)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
EC Number:
813-543-0
Cas Number:
73984-93-7
Molecular formula:
C14H26N2S4
IUPAC Name:
1,3,4-Thiadiazole-2(3H)-thione, 5-(tert-dodecyldithio)-
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Denver, PA
- Weight at study initiation: 2.1 to 2.4 kg
- Fasting period before study: No
- Housing: Individually housed in stainless steel cages (61.0 x 45.5 x 42.0 cm)
- Diet: Rabbits were fed Purina Rabbit Chow Complete Blend (Ralston Purina Co.) ad libitum
- Water: ad libitum
- Acclimation period: approx. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 40 (relative)
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
1981-09-21 - 1981-10-5

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Each animal had one treated eye (right eye) and one untreated eye (left eye) which served as the control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Instilled into the right eye on day 1 and allowed to remain throughout the duration of the observation period (i.e. no rinsing).
Observation period (in vivo):
14 days, with ocular examinations on day 1, 2, 3, 4, 7 and 14 following test material administration.
Number of animals or in vitro replicates:
6 females
Details on study design:
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: fluorescein and ultraviolet light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not Applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Ocular irritation was not observed in any treated rabbits during the study.
Other effects:
During the course of the study, none of the animals exhibited a positive reaction.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test report describes a valid guideline study without information about GLP compliance. The test substance was not irritating to the rabbit eye under the conditions of the study.
Executive summary:

An eye irritation study was conducted using a similar procedure to that described in the current OECD Guideline 405 (Reckers, 1981). The test material (CAS No. 73984 -93 -7) was applied at a volume of 0.1 mL to the right eye of six female rabbits (strain: New Zealand White). The test article was left in the right eye (i.e. no rinsing was performed) and the rabbits were observed during application followed by a 14 -day observation period. The left eye served as control. The treated eye was scored at day 1, 2, 3, 4, 7 and 14 following instillation. Ocular irritation was not observed in any animal during the study.