Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: ECHA communication on permission to refer - Inquiry number: 06-2120740615-56-0000
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
EC Number:
407-520-0
EC Name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
Cas Number:
80657-64-3
Molecular formula:
C13H20O2
IUPAC Name:
A mixture of: ethyl exo-tricyclo[5.2.1.02,6]decane-endo-2-carboxylate; ethyl-endo-tricyclo[5.2.1.02,6]decane-exo-2-carboxylate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
1 ml
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score 1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score 2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score 3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
No corneal damage or iridial inflamation were observed. A diffuse crimson red colouration of the conjunctivae was observed in two animals, in one at the one at the one hour reading only. Considerable swelling with partial eversion of the eyelids was seen in two animals both at the one hour reading only.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met