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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38, No. 187, Section 1500.42, P.27019
Version / remarks:
Sept. 27, 1973
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Mecoprop
EC Number:
230-386-8
EC Name:
Mecoprop
Cas Number:
7085-19-0
Molecular formula:
C10H11ClO3
IUPAC Name:
2-(4-chloro-2-methylphenoxy)propanoic acid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 3.28 kg, females: 2.85 kg (mean weights).
- Housing: Cages were made of stainless steel with wire mesh walk floors. Floor area: 40 x 51 cm. Animals were housed 1 per cage. No bedding in the cages; sawdust in the waste trays.
- Diet: About 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study in the animal care unit; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours)

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 54 mg of the comminuted test material)
Duration of treatment / exposure:
The test material was not washed out.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The test material was not washed out.

SCORING SYSTEM:
- Based on the Draize appraisal.
- Readings were performed at 1, 24, 48 and 72 hours after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 72 h

Any other information on results incl. tables

Summary of Results

Readings

Animal

Cornea

Iris

Conjunctivae

Symptoms

Individual Irritation Index

Opacity

Area

Redness

Chemosis

Discharge

1 hour

1

1

4

1

2

2

2

PC

37

2

2

4

1

2

2

3

PC

59

3

2

4

1

2

2

2

PC

57

4

1

4

1

2

2

2

-

37

5

1

4

1

2

2

3

PC

39

6

2

4

1

2

2

2

PC

57

Mean

 

48

24 hours

1

2

4

2

3

2

3

PC/S/RE

66

2

3

4

2

3

2

2

PC/S/DC

84

3

2

4

2

3

2

3

PC/S/DC/RE

66

4

2

4

2

3

2

3

PC/S/DC

66

5

2

4

2

3

2

3

PC/S/DC

66

6

2

4

2

3

3

3

PC/S/DC

68

Mean

 

69

48 hours

1

2

4

2

3

3

3

PC/S/RE/DC

68

2

3

4

2

3

3

3

PC/S/DC

88

3

3

4

2

3

3

2

PC/S/DC/RE

86

4

2

4

2

3

2

3

PC/S/DC/RE

66

5

2*

4*

2*

3*

3

3

S1

68

6

2

4

2

3

3

3

PC/S/DC/RE

68

Mean

 

74

72 hours

1

3

4

2

3

3

3

PC/S/RE/DC/S3

88

2

3*

4*

2*

3*

4

3

S1/S3

90

3

3

4

2

3

3

3

PC/S/DC/RE/MV/S3

88

4

3

4

2

3

3

3

PC/S/DC/RE/MV/S3

88

5

3*

4*

2*

3*

4

3

S1/S3

90

6

3

4

2

3

3

3

PC/S/DC/RE/MV/S3

88

Mean

 

89

1392 / 18 = 77 (rounded to the nearest whole number). Primary irritation index is about 77.

* = If in 1 - 5 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead.

S1 = Irritation index could not be read because of suppuration

S3 = Study discontinued after 72 hours because of severe irritation

DC = Detachment of the cornea

MV = Marginal vascularization of the cornea

PC = Pupil contracted

RE = Small retractions in the eyelids

S = Suppuration

Applicant's summary and conclusion

Interpretation of results:
other: EU Category 1, H318: Causes serious eye damage
Conclusions:
Under the conditions of this study, the test material was classified in accordance with EU criteria.
Executive summary:

The potential of the test material to cause irritation to the eyes of rabbits was investigated in accordance with Fed. Reg. 38, No. 187, Section 1500.42, P.27019, a study similar in design to OECD 405.

Six Vienna white rabbits (three males and three females) were treated with an application of 0.1 mL (~54 mg) of test material into the conjunctival sac of the right eyelid. The untreated eye served as a negative control. The eyes were observed for 72 hours following application and assessed using the Draize scale.

Under the conditions of this study, the test material was classified.