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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1983
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Basic Blue 45 MeSO4

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd. Huntingdon, UK
- Housing: single cage
- Weight: 3.0 - 3.2 kg
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): as lib.
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60% r.h.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline after 24 h

SCORING SYSTEM: Draize system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not fully reversible within: 21 d
Remarks on result:
not determinable
Remarks:
heavy staining
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Max. score:
2
Reversibility:
not fully reversible within: 21 d
Remarks on result:
not determinable
Remarks:
heavy staining
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
All animals reacted with severe irritation symptoms at the conjunctivae (reversible within 14 d). From 24 h after treatment the cornea was completely stained blue, the substance was not removable with physiological saline; an effect on deeper tissues and layers of the cornea can be considered (not reversible within 21 d). Effects on iris could not be determined to heavy blue staining. Chemosis reaction was found moderate to severe (reversible within 14 d).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on an OECD 405 study with rabbits, the substance causes severe damage to eyes. The substance is classifiable according to GHS Category 1 due to the lack of reversibility within 21 d (cornea staining).