Orthosulfamuron

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 15 to July 18, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

Commission Directive 92/69/EEC, (B.5)
US EPA OPPTS 870.2400
MAFF 59 Nohsan No. 4200
Deviations: none

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

IR5878
ISO common name: Orthosulfamuron
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals:
Species and Strain: Male and Female New Zealand White rabbits
Age: 2 months
Body weight: 1.8 ÷ 2.3 kg
Housing: for the entire duration of the study the rabbits were kept in metal cages with stainless feeders.
Feed: diet “2 RB 15 GLP certificate” produced by Charles River Italia’s feed licensee Mucedola Srl, Settimo Milanese. The diet was supplemented by the Producer with vitamins and traces elements. The diet was available ad libitum to the animals. Water was distributed ad libitum to the animals
Environmental conditions:
Temperature and humidity measured during the study were 19 ± 2°C and 55 ± 10%, respectively.
Light: artificial lighting with a 12-hour circadian cycle (07:00 – 19:00).

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1g/animal

Observation period (in vivo):

The eyes were examined at 1,24,48 and 72 hours after the test article application. After the 24 hour reading the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.

Number of animals or in vitro replicates:

4 males and 2 females

Details on study design:

Both eyes of each experimental animal provisionally selected for the study were examined within 24 hours of testing. All these rabbits were free of eye irritation ocular defects or pre-existing corneal injury. 0.1g of the test article was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball . The lids were then gently held together for about one second in order to rpevent loss of the material. The other eye (the left eye) served as a control. At 24 hours a washout was performed following the application of one drop of sodium fluorescein.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

other: Conjunctivae Redness

Run / experiment:

Animal #9M

Value:

ca. 1

Results 2

Irritation parameter:

other: Conjunctivae Redness

Run / experiment:

Animal #15M

Value:

ca. 2

Results 3

Irritation parameter:

other: Conjunctivae Redness

Run / experiment:

Animal #20M

Value:

ca. 1

Results 4

Irritation parameter:

other: Conjunctivae Redness

Run / experiment:

Animal #41F

Value:

ca. 1

Results 5

Irritation parameter:

other: Conjunctivae Redness

Run / experiment:

Animal #43F

Value:

ca. 2

Results 6

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #9M

Value:

ca. 1

Results 7

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #15M

Value:

ca. 1

Results 8

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #20M

Value:

ca. 1

Results 9

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #21M

Value:

ca. 2

Results 10

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #41F

Value:

ca. 1

Results 11

Irritation parameter:

other: Conjunctivae Chemosis

Run / experiment:

Animal #43F

Value:

ca. 2

Other effects / acceptance of results:

Redness score (refers to palpebral and bulbar conjunctive, excluding cornea and iris) = 0 (normal), 1 (some blood vessels hyperemic), 2 (Diffuse, crimson colour, individual blood vessels not easily discernible), 3 (Diffuse beefy red)
Chemosis score (lids and or nictitating membranes) = 0 (no swelling), 1 (any swelling above normal), 2 (obvious swelling with partial eversion of lids), 3 (swelling with lids about half closed), 4 (swelling with lids more than half closed)

Any other information on results incl. tables

	Conjunctivae												Cornea						Iris
	Redness						Chemosis						Opacity						Iritis
Rabbit No.	9M	15M	20M	21M	41F	43F	9M	15M	20M	21M	41F	43F	9M	15M	20M	21M	41F	43F	9M	15M	20M	21M	41F	43F
Time
1 h	1	2*	1	2*	1	2*	1	1	1	2*	2*	2*	0	0	0	0	0	0	0	0	0	0	0	0
24 h	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
48 h	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
72 h	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test article IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit eyes.

Executive summary:

IR5878 as such was placed into the conjunctival sac of the right eye of New Zealand White rabbits (4 males and 2 females). 0.1 mg of IR5878 was applied to the eye of each animal for an exposure period of 24 hours.

IR5878 when administrated to rabbits by dermal route is to be considered as NON IRRITANT to the rabbit eyes.