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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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
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:
according to guideline
Guideline:
other: Federal Hazardous Substances Act regulations CFR 16 p.125
Principles of method if other than guideline:
Determine the degree of irritation of the eyes of the albino rabbit.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(morpholinothio)thioxomethyl]morpholine
EC Number:
237-335-9
EC Name:
4-[(morpholinothio)thioxomethyl]morpholine
Cas Number:
13752-51-7
Molecular formula:
C9H16N2O2S2
IUPAC Name:
morpholin-4-yl morpholine-4-carbodithioate
Constituent 2
Reference substance name:
Cure-Rite® 18; purity: not noted
IUPAC Name:
Cure-Rite® 18; purity: not noted

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR part 3.

Temperature: 70 deg F +/- 2 deg F
Relative Humidity: 45% +/- 5%
Light was maintained at 12 hours dark/12 horus light.
Diet: Wayne 15% Rabbit Ration and tap water provided ad libitum.
Caging: stainless steel with elevated wire mesh flooring. 1 rabbit per cage.
Bedding: deotized animal cage board

Each animal was examined with fluorescein dye in order to detect any pre-existing corneal injury.

Test system

Vehicle:
not specified
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
The dose was applied to the right eye of each animal, the right eye remained untreated to serve as controls.
Exanimation of the treated eyes was done on day 1, 2, 3, 4, and 7 days after application.
Observation period (in vivo):
7 days.
Number of animals or in vitro replicates:
9 rabbits.
Details on study design:
the first six rabbits did not have their eyes washed subsequent to instillation. the 3 remaining rabbits had the treated eyes washed after 30 seconds for 1 minute with tepid tap water (rate of flow approximately 1000 ml/minute).

Examinations with fluorescein dye were made at the same intervals to confirm the results seen by gross observation. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
all animals
Time point:
other: 7 days
Score:
0
Irritation parameter:
cornea opacity score
Time point:
other: days 1-7
Score:
0
Max. score:
80
Irritation parameter:
iris score
Time point:
other: days 1-7
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
unwashed group (4 affected)
Time point:
other: day 1
Score:
3.3
Max. score:
20
Reversibility:
fully reversible
Remarks on result:
other: no irritation observed by day 2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
washed group
Time point:
other: days 1-7
Score:
0
Max. score:
20
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24/48/72 hour score not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24/48/72 hour score not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24/48/72 hour score not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: 24/48/72 hour score not specified
Irritant / corrosive response data:
4 out of 6 animals with unwashed treated eyes had a total ocular irritation score between 2 - 8 on day 1, followed by a score of 0 on days 2 - 7.
All 3 animals with washed treated eyes had a total ocular irritation score of 0 on days 1 - 7.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Federal Hazardous Substances Act Regulations, CFR 16 p125, section 1500.42
Conclusions:
The material is not a primary ocular irritant within the definition of the above regulations.
Material is not an ocular irritant in the unwashed or washed eye.