Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 - 17 Apr 2009
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
OECD 405
Deviations:
yes
Remarks:
The increase of temperature (up to 23.5 C) in conventional animal room was observed during study. The limit prescribed in EU Methid B.4, for temperature of animal room is 20 +/- 3 C. This perturbation in air-conditioning was caused by the defect of an air
GLP compliance:
yes (incl. QA statement)
Remarks:
sukls28108/2009

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
EC Number:
700-283-7
Molecular formula:
Exact molecular formula is not known as it is a reaction mass. Empiric formula: C5H5FeC5H4COCmHn
IUPAC Name:
Reaction products of acetic acid and acetylferrocene and butan-1-ol and 2-methylpropan-1-ol and propan-1-ol and propan-2-ol
Details on test material:
According to INQ-C-0000036278-61-01, INQ-C-0000036386-62-01, and INQ_RESULT_INQ-C-0000036417-65-01 from ECHA, identification of a substance has been changed to UVCB substance. Name of the substance on the study results is the old name (reaction mass of butan-1-ol and propan-2-ol, ReduxCo), however these reports should be regarded valid as all studies were performed on the substance that is being registered - ReduxCo.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand Red

Test system

Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
24 hours after application of test substance, eye was irrigated with water.
Observation period (in vivo):
the eye was examined at 1, 24, 48 and 72 hours after application and than daily till 8th day.
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 5, 6
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal: 5, 6
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 5, 6
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: 5, 6
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Other effects:
No symptoms of systemic toxicity were observed in the animals during clinical observation in the test period and no mortality occurred.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Evaluation of results after single application demonstrated that the test substance, ReduxCo, is mildly irritating for eye of rabbit but the injury observed was largely not persistent.
Based on the test results and according to EC criteria, classification for ReduxCo is: not eye irritating/corrosive.
Executive summary:

Evaluation of results after single application demonstrated that the test substance, ReduxCo, is mildly irritating for eye of rabbit but the injury observed was largely not persistent.

Classification for ReduxCo: not eye irritating/corrosive.