Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulphuric diamide
EC Number:
232-262-9
EC Name:
Sulphuric diamide
Cas Number:
7803-58-9
Molecular formula:
H4N2O2S
IUPAC Name:
Sulphuric diamide
Test material form:
solid: crystalline
Specific details on test material used for the study:
Supplier: Changzou Foreign Trade Corp.Batch No.: 0073A15 (A01141026)Physical state: Solid, crystalline substanceColour: WhiteOdour: PungentStorage in a cool, dry place, protected from light

Test animals / tissue source

Species:
chicken
Strain:
other: ROSS 308
Details on test animals or tissues and environmental conditions:
Source: TARAVIS KFT. Sárvár, HungaryHead collection was performed by a slaughter house technician. Heads were removed immediately after sedation of the chickens (sedation was happened by electric current). The heads were transported to TOXI-COOP ZRT. at the earliest convenience for use approximately within 2 hours from collection. The ambient temperature was optimal (20.1 ºC to 20.8 ºC) during the transport. All eyes used in the assay were from the same groups of eyes collected on one specific day.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The SULFAMIDE and Imidazole (positive control) were ground before use in the study. They were applied in an amount of 0.03 g/eye by powdering the entire surface of the cornea attempting to cover the cornea surface uniformly with the test substance or positive control.
Duration of treatment / exposure:
The time of application was monitored, then after an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with 20 mL saline solution at ambient temperature.
Duration of post- treatment incubation (in vitro):
The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Number of animals or in vitro replicates:
Three test item treated eyes and three positive control eyes were used in this study.

Results and discussion

In vitro

Results
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Observation

Value

ICE Class

Mean maximum corneal swelling at up to 75 min

1 %

I

Mean maximum corneal swelling at up to 240 min

2 %

I

Mean maximum corneal opacity

0.5

I

Mean fluorescein retention

1.0

II

Other Observation

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this in vitro eye corrosives and severe irritants study, using the Isolated Chicken Eye model with SULFAMIDE, no ocular corrosion or severe irritation potential was observed. According to the guideline OECD 438, SULFAMIDE has been categorized as “No Category”.

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