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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method of Draize (1944)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Di(morpholin-4-yl) disulphide
EC Number:
203-103-0
EC Name:
Di(morpholin-4-yl) disulphide
Cas Number:
103-34-4
Molecular formula:
C8H16N2O2S2
IUPAC Name:
4-(morpholin-4-yldisulfanyl)morpholine
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or tissues and environmental conditions:
no

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of DTDM, as a finely ground powder
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hr

SCORING SYSTEM: The Draize Method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
8.4
Max. score:
20
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: "conjunctivae score" not detailed in the report
Irritant / corrosive response data:
Immediate = slight discomfort ; At 1 hour = moderate erythema, slight edema, copious discharge; At 24 hours = moderate to severe erythema, very slight edema, copious discharge containing whitish exudate ; At 48 hours and at 72 hours = gradual improvement; At 168 hours = all animals scored "0".

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
4,4'-dithiodimorpholine was not irritating for the eyes.
Executive summary:

In a pre-guideline study, 100.0 mg of 4,4'-dithiodimorpholine, as a finely ground powder, was applied to one eye of six albino rabbits. The other eye was not treated and served as a control. The cornea, iris and conjuntivea were examined immediately after treatment, and then at intervals of 1 hour, and at 24, 48, 72 and 168 hours. The Draize Method was used for scoring eye irritation. A slight discomfort was observed immediately after the instillation. At 1 hour, moderate erythema, slight edema and copious discharge were observed. At 24 hours, moderate to severe erythema, very slight edema, and copious discharge containing whitish exudate were still observed. At 48 and 72hours, the effects gradually improved. At 168 hours, all animals scored “0”. The average Draize score for 24, 48 and 72 hours was calculated for each animal and then averaged over the six animals. The average Draize score was 8.4 on a scale from 0-110. 4,4'-dithiodimorpholine is considered as not eye irritant.