Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Draize test according to Draize and Kelly (1952)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Comparable to guideline study with acceptable restrictions; short observation periode (up to 72 h).
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1996
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Method: other: Draize test according to Draize and Kelly (1952), Drug Cosmet. Industr. 71, 36 and FDA (1963), Fed. Reg. 28, 119, 5582
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
other TS: Compound WTR 15 Nonox TBC (corresponding to Vulkanox KB)

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:
not required
Amount / concentration applied:
undiluted
Amount applied: 100 other: mg
Duration of treatment / exposure:
whole observation period
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
see text field materials and methods

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no ulceration or opacity
Remarks on result:
other: no ulceration or opacity
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: fully reversible
Irritant / corrosive response data:
see text field results
Other effects:
no data

Any other information on results incl. tables

6 of 6 rabbits showed slight conjunctivitis after 24 hours.
Symptoms were completely reversible after 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).
Executive summary:

Transient slight conjunctivitis was seen one day after administration of BHT. The symptoms were completely reversible after 72 h (Bomhard 1996).