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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal: #1, #3
Time point:
other: mean 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 6 days

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In a primary eye irritation study 100 mg of 1,3-Dioxan-2-one (TMC) was instilled into the conjunctival sac of 3 New Zealand White rabbits. All effects were fully reversible within 6 days. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.