Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (comparable to guidelines/standards)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979
Reference Type:
publication
Title:
o-TOLUIDINE CAS No: 95-53-4 SIDS Initial Assessment Report.
Author:
OECD SIDS
Year:
2006
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Fed. Reg. 38, No. 187, §1500.42, p. 27019
Principles of method if other than guideline:
Draize test
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine
Test material form:
other: liquid
Details on test material:
- Name of test material: o-Toluidine
- Physical state: liquid
- Analytical purity: 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
-Source: Gaukler; Germany
-Sex: male and female
-Age at test initiation: no data
-Weight at test initiation: male: 3.12kg, 2.91kg, 2.76kg, 2.99kg; female: 2.50kg, 2.61kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
100 µl of the test substance were applied into the conjunctival sac of one eye of each of 6 White Vienna rabbits
Duration of treatment / exposure:
single eye instillation, the lids are then gently held together for one second and the animal is released
Observation period (in vivo):
The animals were observed once on the treatment day and 24, 48, 72 hours as well as 8 days after application
Number of animals or in vitro replicates:
6
Details on study design:
100 µl of the test substance were applied into the conjunctival sac of one eye of each of 6 White Vienna rabbits; the lids are then gently held together for one second and the animal is released.The animals were observed once on the treatment day and 24, 48, 72 hours as well as 8 days after application : SCORING SYSTEM: according to Draize Score


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, and 72 hours
Score:
0.6
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, and 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Treatment led to slight corneal opacity, slight to moderate conjunctival edema and redness. All findings were not fully reversible within the 8 days observation period. The control eyes, which were not treated did not show any reaction except for one animal, which showed slight conjunctival redness after 48h.

Any other information on results incl. tables

Time (hrs)

Individual scoring

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

Corneal opacity

24 h

1

1

1

1

1

1

48 h

1

1

1

*

1

1

72 h

1

1

1

1

1

1

Mean

1

1

1

1

1

1

Iris

24 h

0

0

0

0

1

0

48 h

0

0

1

*

1

1

72 h

1

1

1

1

1

1

Mean

0.33

0.33

0.66

0.5

1

0.66

Redness

24 h

2

2

2

2

2

2

48 h

2

2

2

*

2

2

72 h

2

2

2

2

2

2

Mean

2

2

2

2

2

2

Chemosis

24 h

2

2

2

2

2

2

48 h

1

2

2

2

2

2

72 h

1

2

1

2

1

1

Mean

1.33

2

1.66

2

1.66

1.66

*= evaluation not possible, because eyelids sticked together

Time (hrs)

Individual scoring

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

Corneal opacity

8 days

1

1

1

1

1

1

Iritis

8 days

1

1

1

1

1

1

Redness

8 days

1

1

1

1

1

1

Chemosis

8 days

1

1

0

1

1

0

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

BASF, 1979:

An eye irritation study was conducted on 6 rabbits, according to Fed. Reg. 38 No 187,1500.42, 1973. o-toluidine was judged to be irritating due to slight corneal opacity of the total corneal area, slight to moderate conjunctival edema and redness. The effects were not fully reversible within the short observation time of 8 days instead of 21 days as usual nowadays.