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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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
The procedure conforms to that described in the Code of Federal Regulations 16 Commercial practices Chapter II, part 1500.42, January 1, 1977. Six albino New Zealand rabbits were used for each test substance. One hour prior to instillation of the test substance, the ocular irritation grades were determined using a modified Draize grading system for ocular lesions. In addition both eyes of each rabbit were stained with 2% sodium fluorescein and examined to confirm the absence of corneal lesions. 0.1 ml of flake was placed in one eye of the animals. The eyes are examined at 24, 48, and 72 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methylene dianiline
- Physical state: creamy coloured flaky solid
- Analytical purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
the eyes remained unwashed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: Draize scoring


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see table 1 for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 h
Score:
1.22
Max. score:
3
Reversibility:
fully reversible within: 72 h (except 1 animal)
Remarks on result:
other: no rabbit had score ≥ 2, more details in table 1
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
other: 24-48-72 h
Score:
0.56
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: see table 1 for details
Irritant / corrosive response data:
No irritation responses were observed in the control eyes. Details on irritation responses in the exposed eyes are reported in table 1.

Any other information on results incl. tables

Table 1: Draize scoring of ocular irritation after treatment with test substance

Time point

 

Observations

 

Animal No

1

2

3

4

5

6

24 h

Cornea

0

0

2

2

1

1

Iris

0

0

0

0

0

0

Conjunctivae

2

2

2

2

2

2

Chemosis

1

1

1

1

1

1

48 h

 

 

 

Cornea

0

0

1

1

1

1

Iris

0

0

0

0

0

0

Conjunctivae

1

1

2

2

2

1

Chemosis

0

0

1

1

1

0

72 h

 

 

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

0

0

0

0

0

1

Chemosis

0

0

0

0

0

0

Mean

(24-48-72 h)

Cornea

0.0

0.0

1.0

1.0

0.67

0.67

Iris

0.0

0.0

0.0

0.0

0.0

0.0

Conjunctivae

1.0

1.0

1.33

1.33

1.33

1.33

Chemosis

0.33

0.33

0.67

0.67

0.67

0.67

Mean(24-48-72 h) for all 6 rabbits

Cornea

0.56

Iris

0.0

Conjunctivae

1.22

Chemosis

0.56

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU