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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in 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:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
EC Number:
618-690-2
Cas Number:
90982-32-4
Molecular formula:
C15H15ClN4O6S
IUPAC Name:
ethyl 2-({[(4-chloro-6-methoxypyrimidin-2-yl)carbamoyl]amino}sulfonyl)benzoate
Test material form:
solid
Remarks:
White
Details on test material:
95 to >99% purity
Specific details on test material used for the study:
Physical state: White solid;
Analytical purity: 97.4%;
Lot/batch No.: JUL05MA037;
Stability under test conditions: The test substance was expected to be stable for the duration of testing;
Storage condition of test material: Room temperature; pH of 1% aqueous dispersion: 6.0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Robinson Services, Inc. Clemmons, NC;
Age at study initiation: not stated;
Weight at study initiation: 2112-2278 g;
Housing: The animals were singly housed in suspended stainless steel caging with mesh floors;
Acclimation period: 12 or 13 days;
Environmental conditions: Animal Room Temperature and Relative Humidity Ranges: 20-22°C and 22-44%, respectively (Note: The humidity was below the targeted lower limit for three days during the study. A portable humidifier was used to increase the humidity levels during this time); Photoperiod: 12 hour light/dark cycle

Test system

Vehicle:
water
Controls:
other: The untreated left eye of each rabbit served as the control
Amount / concentration applied:
70 mg
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Initially, one-tenth of a milliliter (0.07 g) of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. Since irritation cleared by 48 hours and there was no significant irritation observed in this animal, the test was completed on two additional animals, as described above.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
According to the U.S. EPA and under the conditions of this study, chlorimuron ethyl is classified in Toxicity Category IV. A score of 1 for conjunctival redness is not considered to be a positive response.

In accordance with the provisions of Directive 67/548/EEC, classification is not required based on the results of this study.

According to the United Nations Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.

According to the provisions of Regulation (EC) No. 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required.
Other effects:
Discharge graded on 1-2 on a 4-point scale was observed in all three rabbits, one hour after instillation. No discharge was seen at the 24-hour observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the United Nations Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation from a single instillation via the ocular route. One-tenth of a milliliter (70 mg) of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al. (OECD 405).

There was no corneal opacity or iritis observed in any treated eye during the study. Conjunctival redness (scores of 1 and/or 2), chemosis (score of 1) and/or discharge (score of 1 or 2) were noted in the treated eye of all three rabbits. All animals were free of ocular irritation by 48 hours.