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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:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF Japan, 59 NohSan No. 4200 (1985)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
EC Number:
603-520-1
Cas Number:
131807-57-3
Molecular formula:
C22H18N2O4
IUPAC Name:
5-methyl-5-(4-phenoxyphenyl)-3-(phenylamino)-1,3-oxazolidine-2,4-dione
Test material form:
solid
Specific details on test material used for the study:
Substance ID: DPX-JE874-221 Technical
Lot #: DPX-JE874-221
Purity: 97.4%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey
- Weight at study initiation: 2094 to 2277 g
- Housing: The rabbits were housed singly in suspended, stainless steel, wire-mesh cages.
- Diet: Approximately 125 grams/day
- Water: ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 2°C
- Humidity: 50 ± 10%
- Photoperiod: 12-hour light/12-hour dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated with the test substance and served as a control.
Amount / concentration applied:
Approximately 20 mg (a weight equivalent to a 0.1 mL volume of test substance)
Duration of treatment / exposure:
The treated and control eyes of all animals remained unwashed.
Observation period (in vivo):
Approximately 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
06 Males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not done

SCORING SYSTEM: Draize Scale

TOOL USED TO ASSESS SCORE: Illumination and magnification

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance produced conjunctival redness (score of 1 or 2) and chemosis (score of 1) in all treated rabbit eyes. Iritis (score of 1) was observed in 1 rabbit and discharge (score of 2) was observed in 1 rabbit only at the 1-hour evaluation. All ocular irritation resolved by 72 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is considered as non irritating to rabbit eyes
Executive summary:

The study was conducted according to OECD guideline 405 and EPA guideline 81-4.


The test substance was evaluated for acute eye irritation potential in 6 male young adult New Zealand White rabbits. Approximately 20 mg (occupying a volume of approximately 0.1 mL) was administered to 1 eye of each test animal. The eyes remained unwashed following treatment.


The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration of the test substance.


The test substance produced conjunctival redness (score of 1 or 2) and chemosis (score of 1) in all treated rabbit eyes. Iritis (score of 1) was observed in 1 rabbit and discharge (score of 2) was observed in 1 rabbit only at the 1-hour evaluation. All ocular irritation resolved by 72 hours after treatment.


The over all mean irritation scores of all the animals (at 24, 48 and 72 h post application) were 0.2, 0.4, 0.0, and 0.0 for conjunctival chemosis, conjunctival redness, iritis and corneal opacity, respectively.


On the basis of the overall averages of the mean values, and according to the guide to the labeling of dangerous substances published in the Official Journal of the European Communities (EEC Directive 93/21), the test substance can be classified as "Non-irritant" and labeled:


Symbol - None


Risk Phrase – None


According to the guidance provided by the U.S. EPA for toxicity classification and label statements for eye hazards of pesticides, the test substance is classified in Toxicity Category III since all positive irritant effects resolved by 48 hours after treatment.