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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-405 guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
GLP Certificate as an annexe in the study report.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1h, 24h, 48h and 72h; + day 4 and day 21 for reversibility
Number of animals or in vitro replicates:
3 per group
Details on study design:
0,1 ml instilled in one eye of each rabbit, after being heated at 80°C, the other eye serving as control.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
chemosis + lacrymation + redness + iris + cornea degree of clouding+ cornea extent of opacity
Basis:
mean
Time point:
other: 24 hours
Score:
>= 5 - <= 43.7
Max. score:
43.7
Reversibility:
fully reversible within: 9 days

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The Appyclean-6505 is irritating for the eyes with a specific concentration limit of 10%.