Registration Dossier

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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995
Reference Type:
other: amendment
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animal species: rabbit / White New Zealand (SPF)
Animal supplier: Dr. K. Thomae GmbH, Biberach, Germany
Age of the animals: young adult animals
Animal identification: ear tattoo
Room temperature/ Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 -24 °C for temperature and of 30 -70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating,
No. of animals per cage: single housing
Bedding: no bedding in the cages; sawdust in the waste trays
Drinking water: about 250 ml tap water per animal per day
Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in tue study was assayed for chemical and microbiological contaminants.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL bulk volume (about 42 mg of the comminuted test substance)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 h

SCORING SYSTEM:
According to OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1-#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
other: area of cornea involved
Basis:
animal: #1 - #3
Time point:
24/48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 - #3
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
other: discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

 Readings  Animal  Cornea     Iris  Conjunctiva      
     Opacity  Area    Redness  Chemosis  Discharge
               
1 hour   1  0  0  0  2  2  2
   2  0  0  0  2  2  2
   3  0  0  0  2  2  2
 24 hours  1  0  0  0  2  1  1
   2  0  0  0  2  1  1
   3  0  0  0  2  1  1
 48 hours  1  0  0  0  1  0  1
   2  0  0  0  2  1  0
   3  0  0  0  1  0  0
 72 hours  1  0  0  0  1  0  0
   2  0  0  0  1  0  0
   3  0  0  0  1  0  0
 8 days  1  0  0  0  0  0  0
   2  0  0  0  0  0  0
   3  0  0  0  0  0  0
 MEAN  1  0.0    0.0  1.3  0.3  
   2  0.0    0.0  1.7  0.7  
   3  0.0    0.0  1.7  0.4  
 MEAN    0.0    0.0  1.6  0.4  

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met