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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
Nature of substance: dry substance

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
not required
Amount / concentration applied:
57 MG
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.6
Max. score:
3
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score over 3 timepoints)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
There were no signs of toxicity or ill health in any rabbit
during the observation period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
A single instillation of RSS-4,dry substance into the eye of the rabbit elicited well defined conjuctival irritation only. All reactions had resolved four or seven days after instillation. The ocular irritation characteristics of RSS-4 have been assessed against the labelling criteria in accordance with Commission Directive 93/21EEC and it does not require labelling R36 "Irritating to eyes".