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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited documentation, only 2 animals tested, only 50 µl applicated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1967

Materials and methods

Principles of method if other than guideline:
The test substance was applied as a single instillation (50 µl) as powder, the substance was not washed out, only 2 rabbits were used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity ca. 90-96% (0-3% urea, 2% potassium sulfate)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
no further data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: treated with talcum powder
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 microliter (50 mm3)
Duration of treatment / exposure:
single instillation of the test substance as powder, the substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none, substance not washed out

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
0.5
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1/2 animals score 0; 1/2 animals score 1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48/72 hours
Score:
0

Any other information on results incl. tables

Summary:

The treatment led to slight redness. All findings were reversible after 8 days of observation period. The control eyes which were treated with talcum powder did show the same reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean score observed for redness of the conjunctivae is 0.167 ( for 24, 48 and 72 hours) which is below 2.5.
These finding were reversible within 48 hours.