Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to Guideline. Not conducted under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-o-toluidine
EC Number:
201-756-6
EC Name:
3-chloro-o-toluidine
Cas Number:
87-60-5
Molecular formula:
C7H8ClN
IUPAC Name:
3-chloro-2-methylaniline
Details on test material:
- Test substance number: 85/48
- name of test substance: 3-chlor-2-methylanilin

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler: D-6065 Offenbach/Main, FRG
- Mean weight at study initiation: 3.02 kg (male), 3.20 kg (females)
- Housing: single
- Diet: Kliba 341, 4 MM; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland; approx. 130 g/animal/day
- Water: approx. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 mL of the unchanged test item
Duration of treatment / exposure:
15 days, since no wash out was performed.
Observation period (in vivo):
15 days
reading time points: 1 h, 24 h, 48 h, 72 h, 8 days and 15 days after application
Number of animals or in vitro replicates:
3 (1 male; 2 females)
Details on study design:
SCORING SYSTEM: according to Draize, as recommended by the OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal: #1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: individual scores: 2 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
animal: #1, 2 and 3
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: individual scores: 2 - 2 - 2

Any other information on results incl. tables

In animal #1, loss of corneal tissue was noted 1 h after application. Suppuration was observed in animal #2 24 h after instillation. On day 15, loss of hair was noted for animal #1. Marginal vascularization of the cornea was seen in animal #1 and 2 on day 8 and in animal #2 on day 15. Moreover, small retractions in the eyelids were noted in all animals an day 8 and in animals #2 and 3 on day 15. As outlined in the raw data, slight opacity covered the complete corneal surface in all animals throughout the study period. The reversibility of these finding till day 21 is doubtful.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the irreversible signs of corneal opacity in all rabbits, 3-chloro-o-toluidine has to be classified for eye irritation R41 or Category 1 according to EEC/67/548 and Regulation (EU) No. 1272/2008, respectively.