Registration Dossier

Administrative data

Description of key information

skin irritation/corrosion: 
In a primary dermal irritation study according to OECD 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) . In this study 1,3-Dioxan-2-one (TMC) is not a dermal irritant.
Eye irritation:
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. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with water
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In a primary dermal irritation study according to OECD Guideline 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) for 4 h under semi-occlusive conditions. Edema and erythema scores were 0 in all animals at all observation times. In this study 1,3-Dioxan-2-one (TMC) is not a dermal irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Number of animals or in vitro replicates:
3
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Human data on local irritation/corrosion are not available but relevant and reliable in vivo animal data regarding skin and eye irritation are available and are taken into consideration for 1,3 -Dioxan-2 -one (TMC):

Skin irritation/corrosion

In a primary dermal irritation study according to OECD 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) . In this study 1,3-Dioxan-2-one (TMC) is not a dermal irritant.

Eye irritation

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. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.

Respiratory irritation

 

No data on the respiratory irritation of 1,3 -Dioxan-2 -one are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.


Justification for selection of skin irritation / corrosion endpoint:
Guideline study, GLP

Justification for selection of eye irritation endpoint:
Guideline study, GLP

Justification for classification or non-classification

Based on the available data 1,3 -Dioxan-2 -one (TMC) should not be classified as irritating to the skin or eye and requires no labelling according to Regulation (EC) 1272/2008.