N-(aminosulfonyl)-3-chloropropanimidamide hydrochloride

Eye irritation

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:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(aminosulfonyl)-3-chloropropanimidamide hydrochloride

EC Number:

700-156-6

Cas Number:

106649-95-0

Molecular formula:

C3H8ClN3O2S.HCl

IUPAC Name:

N-(aminosulfonyl)-3-chloropropanimidamide hydrochloride

Test material form:

solid: crystalline

Details on test material:

Test item: Chlorosulfamidine hydrochlorideCAS No.: 106649-95-0Batch No.: K41003NPhysical state: solid, crystalline substanceColour: whiteOdour: characteristicStorage: at a temperature of 15 to 30 °C

Test animals / tissue source

Species:

other: Chicken eyes

Details on test animals or tissues and environmental conditions:

Chicken heads collection and transport:Species of chicken: COBB 500. Source: TARAVIS KFT. 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 (19.3 ºC to 20.4 ºC) during the transport. All eyes used in the assay were from the same groups of eyes collected on one specific day. After collection, the heads were inspected for appropriate quality and wrapped with paper moistened with saline, then placed in a plastic box that can be closed (4-5 heads/box).Eyes selection:After removing the head from the plastic box, it was put on soft paper. The eyelids were carefully cut away with scissors, avoiding damaging the cornea. If the cornea was in good condition, the eyeball was carefully removed from the orbit.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

The three test item was treated with 0.03 g/eye chlorosulfamidine hydrochloride.The three positive control eyes were treated in a similar way with 0.03 g Imidazole.One negative control eye was treated with saline solution (9 g/L).

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, while taking care not to damage the cornea but attempting to remove all the residual test item if possible.

Observation period (in vivo):

The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120,180 and 240 minutes after the post-treatment rinse. Minor variations within ±5 minutes wereconsidered acceptable.The cornea thickness and cornea opacity were measured at all time points. Fluoresceinretention was determined at baseline (t=0) and 30 minutes after the post-treatment rinse.

Number of animals or in vitro replicates:

Three test item treated eyes, three positive control eyes and one negative control eye were used in this study.

Details on study design:

The purpose of this Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular corrosivity or severe irritancy of the test item Chlorosulfamidine hydrochloride by its ability to induce toxicity in enucleated chicken eyes. Each eye which was used in this study was collected in the slaughterhouse, eliminating the need for laboratory animals. The test compound was applied in a single dose onto the cornea of isolated chicken eyes in order to potentially classify the test compound as ocular corrosive and/or severe irritant. The damage by the test substance was assessed by determination of corneal swelling, opacity, fluorescein retention and morphological effects. These parameters were evaluated pretreatment and starting at approximately 30, 75, 120, 180, and 240 minutes after the posttreatment rinse. The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological effects. All of the endpoints, with the exception of fluorescein retention (which was determined only at pre-treatment and 30 minutes after test substance exposure) were determined at each of the above time points.

Results and discussion

In vitro

Results

Irritation parameter:

other: ICET

Remarks on result:

other: see

Remarks:

other information result

Other effects / acceptance of results:

In this ICET, Chlorosulfamidine hydrochloride caused ocular corrosion or severe irritation in the enucleated chicken eyes.Positive and negative controls showed the expected results. The experiment was considered to be valid.

Any other information on results incl. tables

Observation	Value	ICE Class
Mean maximum corneal swelling at up to 75 min	3 %	I
Mean maximum corneal swelling at up to 240 min	12 %	II
Mean maximum corneal opacity	3.7	IV
Mean fluorescein retention	1.2	II
Other Observation	Cornea opacity score 3 was observed in two eyes and score 4 was seen in one eye at 30 minutes after the post-treatment rinse

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this in vitro eye corrosives and severe irritants study, using the Isolated Chicken Eye model with Chlorosulfamidine hydrochloride, ocular corrosion or severe irritation potential was observed. According to the guideline OECD 438, Chlorosulfamidine hydrochloride has been categorized as “Category 1”.